NocturiaPhase 2NOCNCT01184859
Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo
A Phase 2 study testing Desmopressin in people with Nocturia, run by Ferring Pharmaceuticals at 36 sites in Japan.
Trial summary
This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients. The trial is designed to characterize the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct dose recommendations in the target patient… Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Nocturia
- What is being tested?
- Desmopressin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 36 sitesJapan
- Study dates
- Jul 2010to Apr 2011
- 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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Given written informed consent prior to any trial-related activity is performed
- Aged 55-75 years
- Mean number of nocturnal voids of at least two per night
- Reached post-menopause (applicable to females only)
Who cannot join
- Evidence of bladder outlet obstruction (BOO); or a urine flow of less than 5 mL/s (applicable to males only)
- A surgical treatment for BOO or prostatic hyperplasia within the past 6 months (applicable to males only)
- Showing symptoms of any of the following diseases and having a mean number of nocturnal voids exceeding four per night: Benign prostatic hyperplasia, overactive bladder, interstitial cystitis, severe stress urinary incontinence
- Psychosomatic or habitual polydipsia
- Urinary retention; or a post void residual volume in excess of 150 mL
- A history or complication of urologic malignancy (e.g. bladder cancer or prostate cancer)
Show all 24Show fewer
- Complication of genito-urinary pathology (e.g. infection, stone, or neoplasia)
- Complication of neurogenic detrusor activity
- Complication or suspicion of heart failure
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Complication of hepatobiliary disease
- Abnormal serum creatinine level
- Complication of hyponatraemia, or serum sodium level <135 mEq/L
- Central or nephrogenic diabetes insipidus (CDI or NDI)
- Syndrome of inappropriate antidiuretic hormone (SIADH)
- Obstructive sleep apnea
- Alcohol dependency or drug abuse
- A job or lifestyle that may interfere with regular night-time sleep
- Previous desmopressin treatment
- Treatment with another investigational product within the past 3 months
- A need for treatment with a prohibited concomitant drug for a complication or other problem
- A mental condition, the lack of decision-making ability, dementia or a speech handicap
- Any other reason that the Investigator believes inappropriate
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
Japan36 sites
Tokyo Women's Medical University Medical Center East
Arakawa City, Tokyo
Kokuho Asahi Central Hospital
Asahi, Chiba
Takayama Clinic
Awagi, Hyōgo
Takayama Hospital
Chikushino-shi, Fukuoka
University of Yamanashi Hospital
Chūō, Yamanashi
Harasanshin Hospital
Fukuoka, Fukuoka
Saku Hospital
Fukuoka, Fukuoka
Southwest Urological Clinic
Fukuoka, Fukuoka
Yakuin Urogenital Hospital
Fukuoka, Fukuoka
Fukushima Red Cross Hospital
Fukushima, Fukushima
Ohara General Hospital
Fukushima, Fukushima
Saiseikai Fukushima General Hospital
Fukushima, Fukushima
Hamamatsu University School of Medicine University Hospital
Hamamatsu, Shizuoka
Jigenji Kubo Clinic
Kagoshima, Kagoshima-ken
Kawahara Hinyoukika
Kagoshima, Kagoshima-ken
Yagi Clinic
Kagoshima, Kagoshima-ken
Kasukabe Chuo General Hospital
Kasukabe, Saitama
National Hospital Organization Kobe Medical Center
Kobe, Hyōgo
Houshikai Group Kano Hospital
Koga, Fukuoka
Koganeibashi Sakura Clinic
Koganei, Tokyo
Jyusendo General Hospital
Kōriyama, Fukushima
Kunitachi Sakura Hospital
Kunitachi, Tokyo
St. Mary's Hospital
Kurume, Fukuoka
Rakusai Newtown Hospital
Kyoto, Kyoto
Shinshu University Hospital
Matsumoto, Nagano
Japanese Red Cross Mito Hospital
Mito, Ibaraki
Suzuki Urological Clinic
Nagano, Nagano
Japanese Red Cross Nagoya Daiichi Hospital
Nagoya, Aichi-ken
Social Insurance Nihonmatsu Hospital
Nihommatsu, Fukushima
National Center for Geriatrics and Gerontology
Ōbu, Aichi-ken
Nanri Urological Clinic
Saga, Saga-ken
Senbokufujii Hospital
Sakai, Osaka
Tohoku University Hospital
Sendai, Miyagi
Kumamoto Rosai Hospital
Yatsushiro, Kumamoto
Yokohama Shin-midori General Hospital
Yokohama, Kanagawa
University of Fukui Hospital
Yoshida, Fukui
About this study
Official title: A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo in Water-loaded Male and Female Japanese Nocturia Patients (Single Dose), and to Study the Efficacy of 4 Different Dose Levels of Minirin Melt and Placebo After 28 Days of Dosing (Multiple Doses)
This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients. The trial is designed to characterize the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct dose recommendations in the target patient population. In particular, the trial is designed to link the duration of action to the clinical endpoint. Furthermore, the trial is designed to describe the safety of four different dose levels of desmopressin.
- Conditions
- Nocturia
- Being tested
- Desmopressin, Placebo
- Keywords
- nocturia, bladder function
- 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 FE992026, Minirin Melt
Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration
PlaceboDrug
Placebo melt tablet for sublingual administration
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin 10µg | Experimental | Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days. Receives: Drug: Desmopressin |
| Desmopressin 25µg | Experimental | Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days. Receives: Drug: Desmopressin |
| Desmopressin 50µg | Experimental | Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days. Receives: Drug: Desmopressin |
| Desmopressin 100µg | Experimental | Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days. Receives: Drug: Desmopressin |
| Placebo | Placebo comparator | Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1
Participants were water-loaded to suppress the endogenous release of vasopressin, thus all antidiuretic activity was generated by desmopressin only. Water-loading was initiated 2 hours before dosing on Day 1. Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.
Measured: Day 1
Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2
Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average number of nocturnal voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
Measured: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Secondary outcomes (14)
Area Under the Urine Osmolality Curve (AUCosm)
Area under the urine osmolality curve, from dose administration to end of action (AUCosm).
Measured: Day 1
Area Under the Urine Production Curve (AUCurine Prod)
Area under the urine production curve, from dose administration to end of action (AUCurine prod)
Measured: Day 1
Time When Urine Production <0.12 ml/kg/Min
Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration due to water-loading should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.
Measured: Day 1
Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2
Duration of first period of undisturbed sleep is defined as the length of time from initial sleep to first awakening.
Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average length of first period of undisturbed sleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
Measured: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Total Sleep Time at Approximately Day 32
Total sleep time is defined as the time spent asleep from initial sleep to final awakening.
Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average of the total time asleep of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
Measured: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Number of Daytime Voids at Approximately Day 32
Number of daytime voids was recorded over three consecutive days per week in diaries kept by study participants. The average number of daytime voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Measured: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32
Number of voids in 24 hours was recorded over three consecutive days per week in diaries kept by study participants. The average number of 24-hour voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Measured: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Nocturnal Urine Volume at Approximately Day 32
Nocturnal urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Measured: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in 24-Hour Urine Volume at Approximately Day 32
Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. The average 24-hour urine volume of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Measured: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32
Twenty-four hour urine volume was recorded over three consecutive days per week in diaries kept by study participants. Urine volume per body weight was calculated. The average 24-hour urine volume per kg of body weight of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Measured: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32
Nocturnal polyuria index is defined as a proportion of nocturnal urine volume to the 24-hour urine volume. Urine volume and time of day of those voids was recorded over three consecutive days per week in diaries kept by study participants. The average nocturnal polyuria index of the 3 days recorded in the last week of the study (between study days 25-32) was compared to the average baseline readings.
Measured: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Nocturia-Related Quality of Life Based on Evaluation Provided by Nocturia Quality of Life Questionnaire (N-QoL) at Approximately Day 32
N-QoL assesses the impact of nocturia on quality of life (QoL) and treatment outcomes. N-QoL is a self-administered questionnaire with 13 items using scales of 0 = no negative impact to QoL to the upper number = signficant negative impact to QoL. The sleep/energy domain consists of 7 questions with a scale of 0 to 28. The bother/concern domain consists of 5 questions for a scale of 0 to 20. The 13th question is an overall assessment scored from 0 to 10. The Total Score includes all 13 questions with a scale of 0 (no negative impact to QoL) to 58 (significant negative impact to QoL).
Measured: Approximately Day 4 (start of period 2) and Day 32
Change From Baseline in Sleep Related Quality of Life Based on the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Approximately Day 32
The Global Score of the Pittsburgh Sleep Quality Index (PSQI) is comprised of Questions 2-9 with a total scale of 0 (no difficulty sleeping) to 21 (severe difficulty). The change in Global Score is Global Score at the end of period 2 (day 32) - Global Score at the start of Period 2 (day 4). A negative change indicates an improvement in quality of life.
Measured: Approximately Day 4 (start of period 2) and Day 32
Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)
Serum sodium levels were monitored throughout the trial as part of the clinical chemistry panel. If the value was ≤125 mEq/L, the participant was to be withdrawn from the trial and treatment stopped immediately. This outcome reports participants' lowest recorded serum sodium levels during the second treatment period.
Measured: Days 4- 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2011
- Study completionApr 2011
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.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184859
- Sponsor's protocol ID
- FE992026 CS36
- Acronym
- NOC
- Status last verified
- Apr 2012
- First submitted
- 18 Aug 2010
- Last updated
- 25 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo in Water-loaded Male and Female Japanese Nocturia Patients (Single Dose), and to Study the Efficacy of 4 Different Dose Levels of Minirin Melt and Placebo After 28 Days of Dosing (Multiple Doses)
- ClinicalTrials.gov ID
- NCT01184859
- Acronym / sponsor ID
- NOC / FE992026 CS36
- Conditions
- Nocturia
- Keywords
- nocturia, bladder function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 19 Aug 2010 (estimated)
- Results
- Posted 25 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients. The trial is designed to characterize the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct dose recommendations in the target patient population. In particular, the trial is designed to link the duration of action to the clinical endpoint. Furthermore, the trial is designed to describe the safety of four different dose levels of desmopressin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Desmopressin 10µg | Experimental | Drug: DesmopressinStudy period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days. |
| Desmopressin 25µg | Experimental | Drug: DesmopressinStudy period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days. |
| Desmopressin 50µg | Experimental | Drug: DesmopressinStudy period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days. |
| Desmopressin 100µg | Experimental | Drug: DesmopressinStudy period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days. |
| Placebo | Placebo comparator | Drug: PlaceboStudy period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Given written informed consent prior to any trial-related activity is performed
- Aged 55-75 years
- Mean number of nocturnal voids of at least two per night
- Reached post-menopause (applicable to females only)
Key exclusion criteria (24 listed)
- Evidence of bladder outlet obstruction (BOO); or a urine flow of less than 5 mL/s (applicable to males only)
- A surgical treatment for BOO or prostatic hyperplasia within the past 6 months (applicable to males only)
- Showing symptoms of any of the following diseases and having a mean number of nocturnal voids exceeding four per night: Benign prostatic hyperplasia, overactive bladder, interstitial cystitis, severe stress urinary incontinence
- Psychosomatic or habitual polydipsia
- Urinary retention; or a post void residual volume in excess of 150 mL
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: FE992026, Minirin MeltDesmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration | Drug | Desmopressin 100µg, Desmopressin 10µg, Desmopressin 25µg, Desmopressin 50µg |
| PlaceboPlacebo melt tablet for sublingual administration | Drug | Placebo |
Primary outcome
Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1
Time frame: Day 1
Participants were water-loaded to suppress the endogenous release of vasopressin, thus all antidiuretic activity was generated by desmopressin only. Water-loading was initiated 2 hours before dosing on Day 1. Urine volume was registered and samples for osmolality check were collected every 30 minutes as long as there was an antidiuretic action defined as a urine production <0.12 mL/kg/min. The hydration should have lasted until end of action, defined as when the urine production returned to >0.12 mL/kg/min, but no longer than 12 hours.
Change From Baseline in Number of Nocturnal Voids After 28 Days of Treatment - Period 2
Time frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Records of nocturia and sleep over three consecutive days per week were kept in voiding-sleep diaries by study participants. The average number of nocturnal voids of the 3 days recorded in the last week of the study (between study days 25-32) was compared to average baseline readings.
14 secondary outcomes
Area Under the Urine Osmolality Curve (AUCosm)
Time frame: Day 1
Area Under the Urine Production Curve (AUCurine Prod)
Time frame: Day 1
Time When Urine Production <0.12 ml/kg/Min
Time frame: Day 1
Change From Baseline in Duration of First Period of Undisturbed Sleep After 28 Days of Treatment - Period 2
Time frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Total Sleep Time at Approximately Day 32
Time frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Number of Daytime Voids at Approximately Day 32
Time frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Number of 24-hour Urine Voids at Approximately Day 32
Time frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Nocturnal Urine Volume at Approximately Day 32
Time frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in 24-Hour Urine Volume at Approximately Day 32
Time frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in 24-Hour Urine Production Per Body Weight at Approximately Day 32
Time frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Nocturnal Polyuria Index at Approximately Day 32
Time frame: 3 days between study days -6 to 0 (Baseline), and days 25 to 32
Change From Baseline in Nocturia-Related Quality of Life Based on Evaluation Provided by Nocturia Quality of Life Questionnaire (N-QoL) at Approximately Day 32
Time frame: Approximately Day 4 (start of period 2) and Day 32
Change From Baseline in Sleep Related Quality of Life Based on the Global Score of the Pittsburgh Sleep Quality Index (PSQI) at Approximately Day 32
Time frame: Approximately Day 4 (start of period 2) and Day 32
Participant Counts of Minimum Observed Serum Sodium Levels During the Second Treatment Period (Days 4-32)
Time frame: Days 4- 32
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Clinical Development Support study director
Ferring Pharmaceuticals
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desmopressin in people with Nocturia, run by Ferring Pharmaceuticals at 36 sites 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 4 inclusion and 24 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 25 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites 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 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 25 May 2012). 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?
Duration of Action Defined as the Time With Urine Osmolality Above 200 mOsm/kg - Period 1 (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2012.