NocturiaPhase 2NCT03201419
A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults
A Phase 2 study testing FE 201836 and Desmopressin in people with Nocturia, run by Ferring Pharmaceuticals at 72 sites in 7 countries.
Trial summary
The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nocturia
- What is being tested?
- FE 201836 and Desmopressin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 72 sitesin 7 countries
- Study dates
- 27 Jul 2017to 31 Oct 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age (at the time of written consent)
- Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1
- ≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2
- The largest single voided volume must be ≥200 mL (at least 1 void ≥200 mL) as documented in the 3-day e-Diary prior to Visit 2
- Nocturnal polyuria, defined as Nocturnal Polyuria index >33%, a ratio of Nocturnal Urine Volume in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2
- ≥20% decrease in the nocturnal diuresis rate (mL/min) (that was recorded at Visit 2) as documented in the 3-day e-Diary prior to Visit 3
Who cannot join
- Current diagnosis of Obstructive Sleep Apnoea (OSA)
- Restless Legs Syndrome (RLS)
- Bladder Outlet Obstruction (BOO) or urine flow <5 mL/s, as confirmed by uroflowmetry upon suspicion during screening prior to Visit 2
- Urinary incontinence defined as an average of >1 episode/day in the 3-day e-Diary prior to Visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary)
- Any pelvic or lower urinary tract surgery and/or radio therapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for Bladder Outlet Obstruction or Benign Prostatic Hyperplasia, hysterectomy or female incontinence procedures
- Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder-related pain, chronic pelvic pain syndrome, or stone in the bladder or urethra causing symptoms
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- A history of cancer with the last date of disease activity/presence of malignancy within the last 12 months prior to Visit 1, except for adequately treated basal cell carcinoma of the skin
- History of any neurological disease affecting bladder function or muscle strength (e.g., Multiple Sclerosis, Parkinson's, spinal cord injury, spina bifida)
- Habitual (fluid intake >3L per day) or psychogenic polydipsia
- Uncontrolled hypertension, as judged by the investigator
- Uncontrolled diabetes mellitus, as judged by the investigator
- Central or nephrogenic diabetes insipidus
- Known history of Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion
- History of gastric retention
- Suspicion or evidence of congestive heart failure, (New York Heart Association (NYHA) class II, III, IV)
- Hyponatraemia:
- Serum sodium level <135 mmol/L at Visit 1(re-tested, with results available within 7 days)
- Serum sodium level <130 mmol/L at Visit 3 (re-tested, with results available within 7 days)
- Use of any prohibited therapy listed below:
- Current or former (within 3 months prior to screening) treatment with any other investigational medicinal product (IMP)
- Unstable electrostimulation or behavioural bladder training program less than 3 months prior to screening (stable electrostimulation or behavioural bladder training program started at least 3 months before screening are acceptable)
- Thiazide diuretics
- Antiarrhythmic agents
- V2-receptor antagonists/agonists (e.g., vaptans/desmopressin, vasopressin)
- Loperamide
- Botulinum toxin (cosmetic non-urological use is acceptable)
- Valproate
Trial locations and contacts
72 sites in 7 countries.
72 sites in 7 countries
United States43 sites
South Florida Medical Research
Aventura, Florida, 33180
American Health Network of Indiana, LLC
Avon, Indiana, 46123
Achieve Clinical Research, LLC
Birmingham, Alabama, 35216
American Health Research, Inc.
Charlotte, North Carolina, 28207
Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Tampa Bay Medical Research, Inc.
Clearwater, Florida, 33761
Ericksen Research & Development, LLC
Clinton, Utah, 84015
Clinical Research of South Florida
Coral Gables, Florida, 33134
Avail Clinical Research, LLC
DeLand, Florida, 32720
Downtown Women's Health Care
Denver, Colorado, 80209
Genitourinary Surgical Consultants, P.C.
Denver, Colorado, 80220
HWC Women's Research Center
Englewood, Ohio, 45322
Finlay Medical Research Corp
Greenacres City, Florida, 33467
American Health Network of Indiana, LLC
Greenfield, Indiana, 46140
Medication Management, LLC
Greensboro, North Carolina, 27408
Peters Medical Research
High Point, North Carolina, 27262
MCA Research - Partner
Houston, Texas, 77079
Beyer Research
Kalamazoo, Michigan, 49009
Clinical Research Consortium, an AMR company
Las Vegas, Nevada, 89119-5190
Clinical Trials Research
Lincoln, California, 95648
Pharmax Research Clinic
Miami, Florida, 33126
Doctors Research Institute Corporation
Miami, Florida, 33145
Sanitas Research
Miami, Florida, 33155
Coastal Clinical Research, an AMR company
Mobile, Alabama, 36608
Coastal Carolina Research Center, Inc
Mt. Pleasant, South Carolina, 29464
PMG Research of Charleston, LLC
Mt. Pleasant, South Carolina, 29464
Tri Valley Urology Medical Group
Murrieta, California, 92562
Bayside Clinical Research LLC
New Port Richey, Florida, 34655
Mid Hudson Medical Research, PLLC
New Windsor, New York, 12553
Clinical Research Associates of Tidewater, an AMR company
Norfolk, Virginia, 23507
Advanced Research Institute
Ogden, Utah, 84405
Quality Clinical Research Center, Inc.
Omaha, Nebraska, 68114
Pines Care Research Center, Inc
Pembroke Pines, Florida, 33026
Clinical Research Center of Florida
Pompano Beach, Florida, 33060
Premier Medical Group of the Hudson Valley, PC
Poughkeepsie, New York, 12601
NECCR Primacare Research, LLC
Providence, Rhode Island, 02908
PMG Research of Raleigh, LLC
Raleigh, North Carolina, 27609
Remedica LLC
Rochester, Michigan, 48307
San Diego Clinical Trials
San Diego, California, 92120
Meridien Research, Inc.
St. Petersburg, Florida, 33709
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, 02472
Advanced Rx Clinical Research Group, Inc.
Westminster, California, 92683
PMG Research of Wilmington, LLC
Wilmington, North Carolina, 28401
Canada10 sites
Milestone Research
London
SKDS Research Inc.
Newmarket
Ultra-Med Inc.
Pointe-Claire, Quebec
Clinique Médicale St-Louis (Recherche) inc d/b/a/ Centre de Recherche Saint-Louis
Québec
DIEX Recherche Quebec Inc.
Québec
Bluewater Health-Norman Site
Sarnia
CHUS - Hôpital Fleurimont
Sherbrooke
DIEX Recherche Sherbrooke Inc.
Sherbrooke
Ferring Investigational Site
Toronto
DIEX Recherche Victoriaville Inc.
Victoriaville
Belgium5 sites
ULB Hopital Erasme
Brussels
UZ Antwerpen
Edegem
Universitair Ziekenhuis Gent
Ghent
AZ Groeninge - Campus Vercruysselaan
Kortrijk
UZ Leuven
Leuven
Czechia5 sites
Urologie Benešov - Afimed s.r.o.
Benešov
Fakultni nemocnice Brno, Dept of Klinika nemoci plicnich a tuberkulozy
Brno
Krajska nemocnice Liberec, a.s.
Liberec
Urocentrum Plzen
Pilsen
Thomayerova nemocnice, PARENT
Prague
Hungary5 sites
Jahn Ferenc Del-pesti Korhaz es Rendelointezet
Budapest
Synexus Magyarorszag Kft.
Budapest
Bagoly Egeszseghaz
Kecskemét
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz, Josa Andras Oktatokorhaz Urologia
Nyíregyháza
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok
Germany3 sites
Gemeinschaftspraxis fuer Urologie und Andrologie
Duisburg
Urologische Gemeinschaftspraxis
Emmendingen
Klinikum Weiden, Klinik f. Urologie, Andrologie und Kinderurologie
Weiden
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, With Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Adults
The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults
- Conditions
- Nocturia
- Being tested
- FE 201836, Desmopressin, Placebo oral solution, Placebo ODT
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FE 201836Drug
Also called Velmupressin
Oral solution for daily intake
DesmopressinDrug
Also called NOCDURNA
Desmopressin Orally Disintegrating Tablet (ODT)
Placebo oral solutionDrug
Manufactured to mimic experimental drug
Placebo ODTDrug
Manufactured to mimic experimental drug
| Study group | Role | What they receive |
|---|---|---|
| FE 201836 500 μg (Randomized Treatment Period) | Experimental | FE 201836 500 μg oral solution and placebo orally disintegrating tablet (ODT), administered once daily Receives: Drug: FE 201836; Drug: Placebo ODT |
| FE 201836 350 μg (Randomized Treatment Period) | Experimental | FE 201836 350 μg oral solution and placebo ODT, administered once daily Receives: Drug: FE 201836; Drug: Placebo ODT |
| FE 201836 250 μg (Randomized Treatment Period) | Experimental | FE 201836 250 μg oral solution and placebo ODT, administered once daily Receives: Drug: FE 201836; Drug: Placebo ODT |
| FE 201836 150 μg (Randomized Treatment Period) | Experimental | FE 201836 150 μg oral solution and placebo ODT, administered once daily Receives: Drug: FE 201836; Drug: Placebo ODT |
| FE 201836 100 μg (Randomized Treatment Period) | Experimental | FE 201836 100 μg oral solution and placebo ODT, administered once daily Receives: Drug: FE 201836; Drug: Placebo ODT |
| FE 201836 50 μg (Randomized Treatment Period) | Experimental | FE 201836 50 μg oral solution and placebo ODT, administered once daily Receives: Drug: FE 201836; Drug: Placebo ODT |
| Placebo (Randomized Treatment Period) | Experimental | Placebo oral solution and placebo ODT, administered once daily Receives: Drug: Placebo oral solution; Drug: Placebo ODT |
| Desmopressin 25 μg (Randomized Treatment Period) | Experimental | Desmopressin 25 μg ODT and placebo oral solution, administered once daily (female subjects) Receives: Drug: Desmopressin; Drug: Placebo oral solution |
| Desmopressin 50 μg (Randomized Treatment Period) | Experimental | Desmopressin 50 μg ODT and placebo oral solution, administered once daily (male subjects) Receives: Drug: Desmopressin; Drug: Placebo oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean number of nocturnal voids equal to 2, and 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval are presented in this endpoint.
Measured: Baseline, during 12 weeks of treatment
Secondary outcomes (45)
Change From Baseline in Mean Number of Nocturnal Voids at Week 1
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
MMRM=Mixed Model for Repeated Measurements.
For all visit-specific results, the tables present the number of subjects with an observation of the endpoints in question at the specific visit. All secondary analyses are performed using the observed-case approach based on repeated measurements for all subjects in the ITT-RT population. That is, these secondary analyses are based on all subjects with at least one non-missing post-baseline observation (with a baseline value if relevant).
Measured: Baseline, Week 1
Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Measured: Baseline, Week 4
Change From Baseline in Mean Number of Nocturnal Voids at Week 8
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Measured: Baseline, Week 8
Change From Baseline in Mean Number of Nocturnal Voids at Week 12
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning.
The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in nocturnal voids are estimated using a baseline value of 2.
Measured: Baseline, Week 12
Responder Rate in Nocturnal Voids at Week 1
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% in the reduction mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Measured: Week 1
Responder Rate in Nocturnal Voids at Week 4
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Measured: Week 4
Responder Rate in Nocturnal Voids at Week 8
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Measured: Week 8
Responder Rate in Nocturnal Voids at Week 12
Defined as 50% reduction in nocturnal voids from baseline.
Adjusted visit-specific estimated odds of at least 50% reduction in the mean number of nocturnal voids are estimated using a baseline value of 2.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Measured: Week 12
Responder Rate in Nocturnal Voids During 12 Weeks of Treatment
Defined as 50% reduction in nocturnal voids from baseline.
Estimated odds of at least 50% reduction in the aggregated mean number of nocturnal voids for a subject with 2 nocturnal voids at baseline are presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
The estimated odd equals the probability of response divided by the probability of non-response; these odds may vary between 0 and infinity. For example, if the probability of responding is 80%, the odd of responding is 4, as it is 4 times more likely to respond (80%) then it is not to respond (20%).
Measured: During 12 weeks of treatment
Change From Baseline in Mean NI Diary Total Score at Week 1
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall quality of life (QoL) impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items.Responses are scored from 0 to 4 (lowest t o highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Measured: Baseline, Week 1
Change From Baseline in Mean NI Diary Total Score at Week 4
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Measured: Baseline, Week 4
Change From Baseline in Mean NI Diary Total Score at Week 8
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Measured: Baseline, Week 8
Change From Baseline in Mean NI Diary Total Score at Week 12
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Total Score are estimated using a baseline value of 40.
Measured: Baseline, Week 12
Change From Baseline in Aggregated Mean NI Diary Total Score During 12 Weeks of Treatment
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). The NI Diary Total Scores are calculated by summing the 11 core items. Responses are scored from 0 to 4 (lowest to highest impact). The NI Diary Total is standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the mean over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean NI Diary Total Score equal to 40 is presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Measured: Baseline, during 12 weeks of treatment
Percentage of Nights With at Most One Nocturnal Void During 12 Weeks of Treatment
The percentages of nights during the treatment period with at most one nocturnal void are presented in this endpoint.
Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
Measured: During 12 weeks of treatment
Percentage of Nights With No Nocturnal Voids During 12 Weeks of Treatment
The percentages of nights during the treatment period with complete response, i.e. no nocturnal voids are presented in this endpoint.
Level estimated for baseline value of mean number of nocturnal voids equal to 2 is presented in this endpoint.
Measured: During 12 weeks of treatment
Change From Baseline in Mean NI Diary Overall Impact Score at Week 1
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Measured: Baseline, Week 1
Change From Baseline in Mean NI Diary Overall Impact Score at Week 4
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Measured: Baseline, Week 4
Change From Baseline in Mean NI Diary Overall Impact Score at Week 8
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Measured: Baseline, Week 8
Change From Baseline in Mean NI Diary Overall Impact Score at Week 12
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NI Diary Overall Impact Score are estimated using a baseline value of 40.
Measured: Baseline, Week 12
Change From Baseline in Aggregated Mean NI Diary Overall Impact Score During 12 Weeks of Treatment
The NI Diary is a 12-item questionnaire with 11 core items (Q1-Q11) and an overall QoL impact question (Q12). For the overall impact question (Q12), response options range from 0 (not at all) to 4 (a great deal). The NI Diary Overall Impact Scores are standardized from 0 to 100 (lowest to highest impact).
The score at each visit was calculated as the average over the three consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean NI Diary Overall Impact Score equal to 40 is presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Measured: Baseline, during 12 weeks of treatment
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 1
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Measured: Week 1
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 4
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Measured: Week 4
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 8
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Measured: Week 8
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 12
The PGI-I is a 1-item questionnaire designed to assess the patient's impression of changes in urinary symptoms. The PGI-I was scored from 1 (very much better) to 7 (very much worse).
Visit-specific PGI-I in urinary symptoms is presented in this endpoint.
Measured: Week 12
Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores at Week 1
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Measured: Baseline, Week 1
Change From Baseline in PGI-S Scores at Week 4
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Measured: Baseline, Week 4
Change From Baseline in PGI-S Scores at Week 8
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Measured: Baseline, Week 8
Change From Baseline in PGI-S Scores at Week 12
The PGI-S is a 1-item questionnaire designed to assess patient's impression of disease severity. The PGI-S was scored from 1 (none) to 4 (severe).
Change from baseline in visit-specific PGI-S is presented in this endpoint.
Level estimated for baseline value of PGI-S equal to 3 is presented in this endpoint.
Measured: Baseline, Week 12
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 1
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Measured: Baseline, Week 1
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 4
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Measured: Baseline, Week 4
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 8
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Measured: Baseline, Week 8
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 12
The Hsu 5-point Likert Bother scale is a questionnaire designed to assess the subjective bothersomeness and functional disruptiveness of nocturia. The Hsu 5 point Likert Bother Scale was scored from 0 (not at all) to 4 (extremely).
Change from baseline in visit-specific Hsu Bother is presented in this endpoint.
Level estimated for baseline value of Hsu Bother equal to 3 is presented in this endpoint.
Measured: Baseline, Week 12
Change From Baseline in ISI at Week 4
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).
Change from baseline in visit-specific ISI is presented in this endpoint.
Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Measured: Baseline, Week 4
Change From Baseline in ISI at Week 8
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).
Change from baseline in visit-specific ISI is presented in this endpoint.
Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Measured: Baseline, Week 8
Change From Baseline in ISI at Week 12
The ISI is a 7-item questionnaire which comprises of four 'sleep-related' items and three 'wake-related' items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28 (higher score suggests more severe insomnia).
Change from baseline in visit-specific ISI is presented in this endpoint.
Level estimated for baseline value of ISI equal to 15 is presented in this endpoint.
Measured: Baseline, Week 12
Change From Baseline in Mean Duration of First Undisturbed Sleep Period (FUSP) at Week 1
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occured.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Measured: Baseline, Week 1
Change From Baseline in Mean Duration of FUSP at Week 4
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Measured: Baseline, Week 4
Change From Baseline in Mean Duration of FUSP at Week 8
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Measured: Baseline, Week 8
Change From Baseline in Mean Duration of FUSP at Week 12
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The duration of FUSP at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in FUSP are estimated using a baseline value of 180 (min).
Measured: Baseline, Week 12
Change From Baseline in Aggregated Mean Duration of FUSP During 12 Weeks of Treatment
The FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occurred.
The visit-specific means were aggregated into a mean of current and preceding visits.
Level estimated for baseline value of mean duration of FUSP (minutes) equal to 180 is presented in this endpoint.
The 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval is presented for this endpoint.
Measured: Baseline, During 12 Weeks of Treatment
Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 1
The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.
Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.
Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
Measured: Baseline, Week 1
Change From Baseline in Nocturnal Diuresis Rate Profiles at Week 12
The nocturnal diuresis rate (mL/min) is calculated as the mean of the nocturnal diuresis for each of the three nights, with the single-night nocturnal diuresis calculated as the ratio of NUV to total time in bed.
Change from baseline in visit-specific mean nocturnal diuresis (mL/min) is presented.
Level estimated for baseline value of mean nocturnal diuresis (mL/min) equal to 1.3 is presented in this endpoint.
Measured: Baseline, Week 12
Change From Baseline in Mean NUV in Week 1
The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.
The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
Measured: Baseline, Week 1
Change From Baseline in Mean NUV at Week 12
The NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep including the first void within 30 minutes of rising in the morning.
The NUV at each visit was calculated as the average over the 3 consecutive 24-hour periods just prior to the respective visit. Adjusted visit-specific mean changes from baseline in NUV are estimated using a baseline value of 750 (mL).
Measured: Baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2017
- Study start27 Jul 2017
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NocturiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The trial consisted of a 2 week period of screening/lifestyle changes during which no treatment was given, a 2 week enrichment period (including a 1 week single blind active run-in period \[FE 201836 500 µg\] and a 1 week washout period) followed by a 12 week randomized treatment period for each subject. Prior to the first interim analysis, the first 129 subjects were randomized to daily treatment with FE 201836 500 µg, placebo, or desmopressin (25 µg for females and 50 µg for males) in a 2:2:1 ratio. After the first interim analysis, subjects were randomized to daily treatment with FE 201836 (50 µg, 100 µg, 150 µg, 250 µg, 350 µg, or 500 µg), placebo, or desmopressin (25 µg for females and 50 µg for males) using response adaptive allocation probabilities.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03201419
- Sponsor's protocol ID
- 000233
- Other IDs
- 2016-003851-31, 2016
- Status last verified
- Oct 2020
- First submitted
- 26 Jun 2017
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hudgens S, Howerter A, Polek E, Andersson FL. Psychometric validation and interpretation of the Nocturia Impact Diary in a clinical trial setting. Qual Life Res. 2022 Jun;31(6):1837-1848. doi: 10.1007/s11136-021-03060-4. Epub 2021 Dec 21.
PubMed 34932192
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, With Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Adults
- ClinicalTrials.gov ID
- NCT03201419
- Acronym / sponsor ID
- 000233
- Conditions
- Nocturia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 28 Jun 2017 (actual)
- Results
- Posted 23 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial was to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
- Model description
- The trial consisted of a 2 week period of screening/lifestyle changes during which no treatment was given, a 2 week enrichment period (including a 1 week single blind active run-in period [FE 201836 500 µg] and a 1 week washout period) followed by a 12 week randomized treatment period for each subject. Prior to the first interim analysis, the first 129 subjects were randomized to daily treatment with FE 201836 500 µg, placebo, or desmopressin (25 µg for females and 50 µg for males) in a 2:2:1 ratio. After the first interim analysis, subjects were randomized to daily treatment with FE 201836 (50 µg, 100 µg, 150 µg, 250 µg, 350 µg, or 500 µg), placebo, or desmopressin (25 µg for females and 50 µg for males) using response adaptive allocation probabilities.
| Arm | Type | Receives |
|---|---|---|
| FE 201836 500 μg (Randomized Treatment Period) | Experimental | Drug: FE 201836, Drug: Placebo ODTFE 201836 500 μg oral solution and placebo orally disintegrating tablet (ODT), administered once daily |
| FE 201836 350 μg (Randomized Treatment Period) | Experimental | Drug: FE 201836, Drug: Placebo ODTFE 201836 350 μg oral solution and placebo ODT, administered once daily |
| FE 201836 250 μg (Randomized Treatment Period) | Experimental | Drug: FE 201836, Drug: Placebo ODTFE 201836 250 μg oral solution and placebo ODT, administered once daily |
| FE 201836 150 μg (Randomized Treatment Period) | Experimental | Drug: FE 201836, Drug: Placebo ODTFE 201836 150 μg oral solution and placebo ODT, administered once daily |
| FE 201836 100 μg (Randomized Treatment Period) | Experimental | Drug: FE 201836, Drug: Placebo ODTFE 201836 100 μg oral solution and placebo ODT, administered once daily |
| FE 201836 50 μg (Randomized Treatment Period) | Experimental | Drug: FE 201836, Drug: Placebo ODTFE 201836 50 μg oral solution and placebo ODT, administered once daily |
| Placebo (Randomized Treatment Period) | Experimental | Drug: Placebo oral solution, Drug: Placebo ODTPlacebo oral solution and placebo ODT, administered once daily |
| Desmopressin 25 μg (Randomized Treatment Period) | Experimental | Drug: Desmopressin, Drug: Placebo oral solutionDesmopressin 25 μg ODT and placebo oral solution, administered once daily (female subjects) |
| Desmopressin 50 μg (Randomized Treatment Period) | Experimental | Drug: Desmopressin, Drug: Placebo oral solutionDesmopressin 50 μg ODT and placebo oral solution, administered once daily (male subjects) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥18 years of age (at the time of written consent)
- Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1
- ≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2
- The largest single voided volume must be ≥200 mL (at least 1 void ≥200 mL) as documented in the 3-day e-Diary prior to Visit 2
- Nocturnal polyuria, defined as Nocturnal Polyuria index >33%, a ratio of Nocturnal Urine Volume in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2
Key exclusion criteria (27 listed)
- Current diagnosis of Obstructive Sleep Apnoea (OSA)
- Restless Legs Syndrome (RLS)
- Bladder Outlet Obstruction (BOO) or urine flow <5 mL/s, as confirmed by uroflowmetry upon suspicion during screening prior to Visit 2
- Urinary incontinence defined as an average of >1 episode/day in the 3-day e-Diary prior to Visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary)
- Any pelvic or lower urinary tract surgery and/or radio therapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for Bladder Outlet Obstruction or Benign Prostatic Hyperplasia, hysterectomy or female incontinence procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FE 201836Also: VelmupressinOral solution for daily intake | Drug | FE 201836 100 μg (Randomized Treatment Period), FE 201836 150 μg (Randomized Treatment Period), FE 201836 250 μg (Randomized Treatment Period), FE 201836 350 μg (Randomized Treatment Period), FE 201836 50 μg (Randomized Treatment Period), FE 201836 500 μg (Randomized Treatment Period) |
| DesmopressinAlso: NOCDURNADesmopressin Orally Disintegrating Tablet (ODT) | Drug | Desmopressin 25 μg (Randomized Treatment Period), Desmopressin 50 μg (Randomized Treatment Period) |
| Placebo oral solutionManufactured to mimic experimental drug | Drug | Desmopressin 25 μg (Randomized Treatment Period), Desmopressin 50 μg (Randomized Treatment Period), Placebo (Randomized Treatment Period) |
| Placebo ODTManufactured to mimic experimental drug | Drug | FE 201836 100 μg (Randomized Treatment Period), FE 201836 150 μg (Randomized Treatment Period), FE 201836 250 μg (Randomized Treatment Period), FE 201836 350 μg (Randomized Treatment Period), FE 201836 50 μg (Randomized Treatment Period), FE 201836 500 μg (Randomized Treatment Period), Placebo (Randomized Treatment Period) |
Primary outcome
Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment
Time frame: Baseline, during 12 weeks of treatment
Nocturnal voids were defined as voids occuring from 5 minutes after bedtime until rising in the morning. The number of nocturnal voids at each visit was calculated as the average over the 3 consecutive 24 hour periods just prior to the respective visit. The visit-specific means were aggregated into a mean of current and preceding visits. Level estimated for baseline value of mean number of nocturnal voids equal to 2, and 95% credibility interval (2.5 and 97.5 percentiles of the posterior distribution) instead of confidence interval are presented in this endpoint.
45 secondary outcomes
Change From Baseline in Mean Number of Nocturnal Voids at Week 1
Time frame: Baseline, Week 1
Change From Baseline in Mean Number of Nocturnal Voids at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Mean Number of Nocturnal Voids at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Mean Number of Nocturnal Voids at Week 12
Time frame: Baseline, Week 12
Responder Rate in Nocturnal Voids at Week 1
Time frame: Week 1
Responder Rate in Nocturnal Voids at Week 4
Time frame: Week 4
Responder Rate in Nocturnal Voids at Week 8
Time frame: Week 8
Responder Rate in Nocturnal Voids at Week 12
Time frame: Week 12
Responder Rate in Nocturnal Voids During 12 Weeks of Treatment
Time frame: During 12 weeks of treatment
Change From Baseline in Mean NI Diary Total Score at Week 1
Time frame: Baseline, Week 1
Change From Baseline in Mean NI Diary Total Score at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Mean NI Diary Total Score at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Mean NI Diary Total Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Aggregated Mean NI Diary Total Score During 12 Weeks of Treatment
Time frame: Baseline, during 12 weeks of treatment
Percentage of Nights With at Most One Nocturnal Void During 12 Weeks of Treatment
Time frame: During 12 weeks of treatment
Percentage of Nights With No Nocturnal Voids During 12 Weeks of Treatment
Time frame: During 12 weeks of treatment
Change From Baseline in Mean NI Diary Overall Impact Score at Week 1
Time frame: Baseline, Week 1
Change From Baseline in Mean NI Diary Overall Impact Score at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Mean NI Diary Overall Impact Score at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Mean NI Diary Overall Impact Score at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Aggregated Mean NI Diary Overall Impact Score During 12 Weeks of Treatment
Time frame: Baseline, during 12 weeks of treatment
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 1
Time frame: Week 1
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 4
Time frame: Week 4
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 8
Time frame: Week 8
Patient Global Impression of Improvement (PGI-I) Urinary Symptoms Scores at Week 12
Time frame: Week 12
Change From Baseline in Patient Global Impression of Severity (PGI-S) Scores at Week 1
Time frame: Baseline, Week 1
Change From Baseline in PGI-S Scores at Week 4
Time frame: Baseline, Week 4
Change From Baseline in PGI-S Scores at Week 8
Time frame: Baseline, Week 8
Change From Baseline in PGI-S Scores at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 1
Time frame: Baseline, Week 1
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Hsu 5-point Likert Bother Scale at Week 12
Time frame: Baseline, Week 12
Change From Baseline in ISI at Week 4
Time frame: Baseline, Week 4
Change From Baseline in ISI at Week 8
Time frame: Baseline, Week 8
Change From Baseline in ISI at Week 12
Time frame: Baseline, Week 12
Change From Baseline in Mean Duration of First Undisturbed Sleep Period (FUSP) at Week 1
Time frame: Baseline, Week 1
Change From Baseline in Mean Duration of FUSP at Week 4
Time frame: Baseline, Week 4
Change From Baseline in Mean Duration of FUSP at Week 8
Time frame: Baseline, Week 8
Change From Baseline in Mean Duration of FUSP at Week 12
Time frame: Baseline, Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 34932192Hudgens S, Howerter A, Polek E, Andersson FL. Psychometric validation and interpretation of the Nocturia Impact Diary in a clinical trial setting. Qual Life Res. 2022 Jun;31(6):1837-1848. doi: 10.1007/s11136-021-03060-4. Epub 2021 Dec 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
72 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FE 201836 and Desmopressin in people with Nocturia, run by Ferring Pharmaceuticals at 72 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, Canada, Belgium, Czechia, Hungary and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Aggregated Mean Number of Nocturnal Voids During 12 Weeks of Treatment (time frame: Baseline, during 12 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03201419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.