NocturiaPhase 3NCT02904759
Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects
A Phase 3 study testing Desmopressin in people with Nocturia, run by Ferring Pharmaceuticals at 1 site in Japan.
Trial summary
The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of male subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Nocturia
- What is being tested?
- Desmopressin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 342 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2016to 29 Sep 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent prior to performance of any trial-related activity
- Man ≥20 years of age
- Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1
- ≥2 nocturnal voids at the end of screening period prior to Visit 2
- Nocturnal polyuria at the end of screening period prior to Visit 2
- Bothered by nocturia on the Hsu 5-point Likert bother scale at Visit 1 and Visit 2
- Has given agreement about contraception during the trial
Who cannot join
- Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 2
- History or evidence of significant obstructive sleep apnoea
- History or diagnosis of any of the following urological diseases at Visit 1:
- Interstitial cystitis or bladder pain disorder
- Suspicion of moderate or severe benign prostate hyperplasia (BPH), defined as international prostate symptom score (IPSS) ≥8 points and:
- Urinary flow <5 mL/s or
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- Post-void residual volume >150 mL
- Stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on prior history
- Chronic pelvic pain syndrome
- Surgical treatment, including transurethral resection, for bladder outlet obstruction (BOO) or BPH within the past 6 months prior to Visit 1
- Symptoms of severe over-active bladder (OAB):
- Defined as an over-active bladder symptom score (OABSS) ≥12 at Visit 1
- Defined as a mean of >8 voids and a mean of ≥1 urgency episode per 24 hours at the end of the screening period prior to Visit 2
- Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence at Visit 1
- Complication of cancer or a history of cancer which has not been in remission for the last 5 years at Visit 1
- Current or a history of urologic malignancies, any lower urinary tract surgery, previous pelvic irradiation, or neoplasia at Visit 1
- History of any neurological disease affecting bladder function or muscle strength at Visit 1
- Habitual or psychogenic polydipsia based on medical history at Visit 1 or 24 hour urine output of >2.8 L based on the voiding diary at Visit 2
- Central or nephrogenic diabetes insipidus at Visit 1
- Syndrome of inappropriate antidiuretic hormone secretion at Visit 1
- Suspicion or evidence of cardiac failure at Visit 1
- Uncontrolled hypertension at Visit 1
- Uncontrolled diabetes mellitus at Visit 1
- Hyponatraemia (serum sodium level <135 mmol/L) at Visit 1
- Renal insufficiency at Visit 1
- Hepatic and/or biliary diseases at Visit 1
- Known or suspected hypersensitivity to desmopressin ODTs or previous desmopressin treatment for nocturia at Visit 1
- Known alcohol or substance abuse at Visit 1
- Work or lifestyle that may interfere with regular night-time sleep at Visit 1, e.g., shift workers
- Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial at Visit 1
- Use of any prohibited therapy during the trial period
Trial locations and contacts
1 site in 1 country.
Japan1 site
Investigational site (there may be other sites in this country)
Tokyo
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Multi-centre Trial Investigating the Efficacy and Safety of Desmopressin (FE 992026) Orally Disintegrating Tablets During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects
The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of male subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.
- Conditions
- Nocturia
- Being tested
- Desmopressin, Placebo
- Medical subject headings
- Nocturia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesmopressinDrug
Also called FE 992026
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin 25 µg | Experimental | Desmopressin ODT Receives: Drug: Desmopressin |
| Desmopressin 50 µg | Experimental | Desmopressin ODT Receives: Drug: Desmopressin |
| Placebo | Placebo comparator | Placebo ODT Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean number of nocturnal voids during 12 weeks of treatment
Assessed by the 3-day voiding diary
Measured: Week 1, 4, 8 and 12
Secondary outcomes (7)
Change from baseline in mean time to first awakening to void
Assessed by the 3-day voiding diary
Measured: Week 1, 4, 8 and 12
Change from baseline in mean nocturnal urine volume
Assessed by the 3-day voiding diary
Measured: Week 1, 4, 8 and 12
Change from baseline in mean Nocturnal Polyuria Index (NPI)
Assessed by the 3-day voiding diary
Measured: Week 1, 4, 8 and 12
Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)
Measured: Week 8 and 12
Change from baseline in Insomnia Severity Index (ISI)
Measured: Week 8 and 12
Change from baseline in bother score
Assessed by the Hsu 5-point Likert bother scale
Measured: Week 8 and 12
Frequency and severity of adverse events
Measured: From screening to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion29 Sep 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 342 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
- NCT02904759
- Sponsor's protocol ID
- 000130
- Status last verified
- Sep 2019
- First submitted
- 14 Sep 2016
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Yamaguchi O, Juul KV, Falahati A, Yoshimura T, Imura F, Kitamura M. Efficacy and safety of 25 and 50 mug desmopressin orally disintegrating tablets in Japanese patients with nocturia due to nocturnal polyuria: Results from two phase 3 studies of a multicenter randomized double-blind placebo-controlled parallel-group development program. Low Urin Tract Symptoms. 2020 Jan;12(1):8-19. doi: 10.1111/luts.12276. Epub 2019 Aug 9.
PubMed 31397969
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Multi-centre Trial Investigating the Efficacy and Safety of Desmopressin (FE 992026) Orally Disintegrating Tablets During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT02904759
- Acronym / sponsor ID
- 000130
- Conditions
- Nocturia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
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 is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of male subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Desmopressin 25 µg | Experimental | Drug: DesmopressinDesmopressin ODT |
| Desmopressin 50 µg | Experimental | Drug: DesmopressinDesmopressin ODT |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo ODT |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Written informed consent prior to performance of any trial-related activity
- Man ≥20 years of age
- Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1
- ≥2 nocturnal voids at the end of screening period prior to Visit 2
- Nocturnal polyuria at the end of screening period prior to Visit 2
Key exclusion criteria (31 listed)
- Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 2
- History or evidence of significant obstructive sleep apnoea
- History or diagnosis of any of the following urological diseases at Visit 1:
- Surgical treatment, including transurethral resection, for bladder outlet obstruction (BOO) or BPH within the past 6 months prior to Visit 1
- Symptoms of severe over-active bladder (OAB):
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 |
|---|---|---|
| DesmopressinAlso: FE 992026 | Drug | Desmopressin 25 µg, Desmopressin 50 µg |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in mean number of nocturnal voids during 12 weeks of treatment
Time frame: Week 1, 4, 8 and 12
Assessed by the 3-day voiding diary
7 secondary outcomes
Change from baseline in mean time to first awakening to void
Time frame: Week 1, 4, 8 and 12
Change from baseline in mean nocturnal urine volume
Time frame: Week 1, 4, 8 and 12
Change from baseline in mean Nocturnal Polyuria Index (NPI)
Time frame: Week 1, 4, 8 and 12
Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)
Time frame: Week 8 and 12
Change from baseline in Insomnia Severity Index (ISI)
Time frame: Week 8 and 12
Change from baseline in bother score
Time frame: Week 8 and 12
Frequency and severity of adverse events
Time frame: From screening to week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Results publication: PubMed 31397969Yamaguchi O, Juul KV, Falahati A, Yoshimura T, Imura F, Kitamura M. Efficacy and safety of 25 and 50 mug desmopressin orally disintegrating tablets in Japanese patients with nocturia due to nocturnal polyuria: Results from two phase 3 studies of a multicenter randomized double-blind placebo-controlled parallel-group development program. Low Urin Tract Symptoms. 2020 Jan;12(1):8-19. doi: 10.1111/luts.12276. Epub 2019 Aug 9.
- ArticleLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desmopressin in people with Nocturia, run by Ferring Pharmaceuticals at 1 site in Japan.
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 7 inclusion and 31 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 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 mean number of nocturnal voids during 12 weeks of treatment (time frame: Week 1, 4, 8 and 12). 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 NCT02904759, 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 11 Sep 2019.