NocturiaPhase 3NCT01262456
Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients
A Phase 3 study testing Desmopressin in people with Nocturia, run by Ferring Pharmaceuticals at 56 sites in 2 countries.
Trial summary
The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- 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
- 395 participants
- Where
- 56 sitesin 2 countries
- Study dates
- Feb 2011to Jan 2012
- Phase
- Phase 3
- 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
- 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
- Male sex 18 years of age or older
- At least 2 voids every night in a consecutive 3-day period during the screening period based on the patient diary.
Who cannot join
- Evidence of severe daytime voiding dysfunction defined as: Urge urinary incontinence (more than 1 episode/day in the 3-day diary period), Urgency (more than 1 episode/day in the 3-day diary period), Frequency (more than 8 daytime voids/day in the 3-day diary period)
- Interstitial Cystitis
- Chronic prostatitis/chronic pelvic pain syndrome
- Suspicion of bladder outlet obstruction (BOO) or a urine flow of less than 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO
- Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia within the past 6 months
- Urinary retention or a post void residual volume in excess of 250 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
Show all 25Show fewer
- Habitual or psychogenic fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours
- Central or nephrogenic diabetes insipidus.
- Syndrome of inappropriate anti-diuretic hormone.
- Current or a history of urologic malignancies e.g. urothelium, prostate, or kidney cancer
- Genitourinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms
- Neurogenic detrusor activity (detrusor overactivity)
- Suspicion or evidence of cardiac failure
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Hyponatraemia: Serum sodium level must be within normal limits
- Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
- Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL
- History of obstructive sleep apnea
- Previous desmopressin treatment for nocturia
- Treatment with another investigational product within 3 months prior to screening
- Concomitant treatment with any prohibited medication, i.e. loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
- Known alcohol or substance abuse
- Work or lifestyle that may interfere with regular nighttime sleep 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
Trial locations and contacts
56 sites in 2 countries.
56 sites in 2 countries
United States51 sites
Radiant Research, Inc.
Akron, Ohio
Hartwell Research Group, LLC
Anderson, South Carolina
Pinnacle Research Group, LLC
Anniston, Alabama
Radiant Research, Inc.
Atlanta, Georgia
South Florida Medical Research
Aventura, Florida
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania
Medical University of South Carolina
Charleston, South Carolina
ClinSearch, LLC
Chattanooga, Tennessee
Radiant Research, Inc.
Chicago, Illinois
Community Research
Cincinnati, Ohio
Women's Medical Research Group, LLC
Clearwater, Florida
Southeastern Medical Research Institute
Columbus, Georgia
Complete HealthCare
Columbus, Ohio
Radiant Research Inc.
Dallas, Texas
Avail Clinical Research, LLC
DeLand, Florida
Genitourinary Surgical Consultants
Denver, Colorado
Radiant Research, Inc.
Denver, Colorado
Radiant Research, Inc.
Edina, Minnesota
Anderson & Collins Clinical Research Inc.
Edison, New Jersey
Urology Center Research Institute
Englewood, New Jersey
Family Medical Center
Foothill Rance, California
AccuMed Research Associates
Garden City, New York
Radiant Research, Inc.
Greer, South Carolina
Medical Affiliated Research Center, Inc.
Huntsville, Alabama
Beyer Research
Kalmazoo, Michigan
FPA Clinical Research
Kissimmee, Florida
Radiant Research
Las Vegas, Nevada
Sunrise Medical Research
Lauderdale Lakes, Florida
Axis Clinical Trials
Los Angeles, California
Advanced Pharma CR, LLC
Miami, Florida
Connecticut Clinical Research Center, LLC
Middlebury, Connecticut
Exemplar Research Inc.
Morgantown, West Virginia
Carolina Urologic Research Center
Myrtle Beach, South Carolina
University Urology Associates
New York, New York
Accelovance
Peoria, Illinois
Penn Urology
Philadelphia, Pennsylvania
DMI Research
Pinellas Park, Florida
Quality Research Incorporated
San Antonio, Texas
Radiant Research, Inc.
San Antonio, Texas
Wilford Hall Medical Center
San Antonio, Texas
Radiant Research, Inc.
Santa Rosa, California
Radiant Research, Inc.
Scottsdale, Arizona
Accelovance
South Bend, Indiana
FutureCare Studies, Inc.
Springfield, Massachusetts
Radiant Research, Inc.
St Louis, Missouri
Pinellas Urology, Inc
St. Petersburg, Florida
Midtown Medical Center
Tampa, Florida
Premiere Pharmaceutical Research
Tempe, Arizona
Advanced Research Institute, Inc.
Trinity, Florida
Bay State Clinical Trials, Inc.
Watertown, Massachusetts
Front Range Clinical Research, LLC
Wheat Ridge, Colorado
Canada5 sites
The Male/ Female Health and Research Centre
Barrie, Ontario
Urology Associates / Urologic Medical Research
Kitchener, Ontario
Investigational Site
North Bay, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
Can-Med Clinical Research, Inc.
Victoria, British Columbia
About this study
Official title: A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males
The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.
- 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 FE992026, MINIRIN®, Nocturin®
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Desmopressin 50 μg Double-Blind / 100 μg Open-Label | Experimental | Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period. Receives: Drug: Desmopressin |
| Desmopressin 75 μg Double-Blind / 100 μg Open-Label | Experimental | Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period. Receives: Drug: Desmopressin |
| Placebo Double-Blind / Desmopressin 100 μg Open-Label | Placebo comparator | Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period. Receives: Drug: Desmopressin; 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 Averaged Over a 3-Month Period
The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below.
Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.
Measured: Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)
Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3
Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
This was the second co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.
Measured: Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)
Secondary outcomes (9)
Change From Baseline in Mean Number of Nocturnal Voids at Month 3
Comparison of the mean number of nocturnal voids at baseline and at the 3-month visit. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to the relevant visits as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
Measured: Day 1 (Baseline), Month 3
Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3
Probability of participants achieving 33% responder status at Month 3 employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the Month 3 visit as recorded in participant diaries. The first morning void was not counted as a nocturnal void.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
Measured: Day 1 (Baseline), Month 3
Change From Baseline in Mean Time to First Nocturnal Void at Month 3
The time to first void was defined as the time from going to bed with the intention of sleeping until first nocturnal void or until waking in the morning in the case where there was no nocturnal void. The first morning void was not counted as a nocturnal void. The time to first void was derived from the sleep and voiding diary. The mean time to first void was calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
Measured: Day 1 (Baseline), Month 3
Change From Baseline in Nocturnal Urine Volume at Month 3
The nocturnal urine volume was derived from the 3-day urine volume diary. The nocturnal urine volume included the volume of the first morning void. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
Measured: Day 1 (Baseline), Month 3
Change From Baseline in 24-Hour Urine Volume at Month 3
Twenty-four hour urine volume was derived from the 3-day urine volume diary. Mean urine volumes were calculated as the average over 3 consecutive 24-hour periods prior to the Month 3 visit.
The secondary efficacy outcomes (#3-7) used a hierarchical step-down approach in the order listed. The active treatment groups were compared to placebo using a step-down approach from highest dose (75 µg) to lowest dose (50 µg).
Measured: Day 1 (Baseline), Month 3
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period
A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.
Measured: From Day 1 through Month 3 (double-blind period)
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period
A TEAE was any adverse event (AE) occurring after start of treatment and within the time of residual drug effect, i.e., within 1 day for desmopressin. An adverse drug reaction (ADR) was any AE assessed by the investigator as possibly or probably related to study drug.
Measured: Month 1 of open-label period (Month 4 of treatment)
Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period
Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.
Measured: Day 1 through Month 3 (double-blind period)
Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period
Serum sodium levels were monitored at each study visit since hyponatremia is a potential serious adverse event associated with daily doses of desmopressin. The serum sodium level must have been within the normal reference range at the Screening Visit for the participant to be eligible for enrollment. A participant was to be withdrawn from the trial if the serum sodium level was <=125 mmol/L at any time.
Measured: Month 1 of open-label period (Month 4 of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 395 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
- NCT01262456
- Sponsor's protocol ID
- FE992026 CS41
- Status last verified
- Sep 2015
- First submitted
- 15 Dec 2010
- Last updated
- 15 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Weiss JP, Herschorn S, Albei CD, van der Meulen EA. Efficacy and safety of low dose desmopressin orally disintegrating tablet in men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013 Sep;190(3):965-72. doi: 10.1016/j.juro.2012.12.112. Epub 2013 Feb 20.
PubMed 23454402
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males
- ClinicalTrials.gov ID
- NCT01262456
- Acronym / sponsor ID
- FE992026 CS41
- Conditions
- Nocturia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Posted 15 Oct 2015
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 confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Desmopressin 50 μg Double-Blind / 100 μg Open-Label | Experimental | Drug: DesmopressinParticipants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period. |
| Desmopressin 75 μg Double-Blind / 100 μg Open-Label | Experimental | Drug: DesmopressinParticipants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period. |
| Placebo Double-Blind / Desmopressin 100 μg Open-Label | Placebo comparator | Drug: Desmopressin, Drug: PlaceboParticipants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants completing the double-blind period were switched to desmopressin 100 μg for the 1-month open-label extension period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent prior to performance of any trial-related activity
- Male sex 18 years of age or older
- At least 2 voids every night in a consecutive 3-day period during the screening period based on the patient diary.
Key exclusion criteria (25 listed)
- Evidence of severe daytime voiding dysfunction defined as: Urge urinary incontinence (more than 1 episode/day in the 3-day diary period), Urgency (more than 1 episode/day in the 3-day diary period), Frequency (more than 8 daytime voids/day in the 3-day diary period)
- Interstitial Cystitis
- Chronic prostatitis/chronic pelvic pain syndrome
- Suspicion of bladder outlet obstruction (BOO) or a urine flow of less than 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO
- Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia within the past 6 months
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®, Nocturin® | Drug | Desmopressin 50 μg Double-Blind / 100 μg Open-Label, Desmopressin 75 μg Double-Blind / 100 μg Open-Label, Placebo Double-Blind / Desmopressin 100 μg Open-Label |
| Placebo | Drug | Placebo Double-Blind / Desmopressin 100 μg Open-Label |
Primary outcome
Change From Baseline in Mean Number of Nocturnal Voids Averaged Over a 3-Month Period
Time frame: Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)
The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during-treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. Change from baseline values for Week 1, and Months 1, 2 and 3 are reported below. Comparison of the mean number of nocturnal voids at baseline and over a 3-month treatment period (obtained by longitudinal analysis of Week 1, and Months 1, 2 and 3) are reported in the statistical analysis. This was the first co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary outcomes in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.
Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids for All During-Treatment Visits up to Month 3
Time frame: Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)
Probability of participants achieving 33% responder status during 3 months of treatment employed a longitudinal analysis assessing nocturnal void information captured in the 3-day diary. A 33% responder was defined as a participant with a decrease of at least 33% in the mean number of nocturnal voids relative to baseline. The number of nocturnal voids was the average over 3 consecutive 24-hour periods prior to Day 1 and prior to the during treatment visits (Week 1, Months 1, 2, 3) as recorded in participant diaries. The first morning void was not counted as a nocturnal void. This was the second co-primary outcome. Superiority to placebo was to be simultaneously demonstrated on the 2 co-primary endpoints in a step-down approach from highest (75 μg) to lowest dose (50 μg), thereby controlling the family-wise error rate at the 5% nominal significance level.
9 secondary outcomes
Change From Baseline in Mean Number of Nocturnal Voids at Month 3
Time frame: Day 1 (Baseline), Month 3
Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3
Time frame: Day 1 (Baseline), Month 3
Change From Baseline in Mean Time to First Nocturnal Void at Month 3
Time frame: Day 1 (Baseline), Month 3
Change From Baseline in Nocturnal Urine Volume at Month 3
Time frame: Day 1 (Baseline), Month 3
Change From Baseline in 24-Hour Urine Volume at Month 3
Time frame: Day 1 (Baseline), Month 3
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Double-Blind Period
Time frame: From Day 1 through Month 3 (double-blind period)
Summary of Participants With Treatment-Emergent Adverse Events (TEAEs) in the Open-Label Period
Time frame: Month 1 of open-label period (Month 4 of treatment)
Minimum Post-Treatment Serum Sodium Levels in the Double-Blind Period
Time frame: Day 1 through Month 3 (double-blind period)
Minimum Post-Treatment Serum Sodium Levels in the Open-Label Period
Time frame: Month 1 of open-label period (Month 4 of treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23454402Weiss JP, Herschorn S, Albei CD, van der Meulen EA. Efficacy and safety of low dose desmopressin orally disintegrating tablet in men with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013 Sep;190(3):965-72. doi: 10.1016/j.juro.2012.12.112. Epub 2013 Feb 20.
Related trials for Nocturia
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Active, not recruitingPhase 1/2
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
Survivorship, Prostate Cancer
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
56 sites in 2 countries: 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 56 sites in 2 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 3 inclusion and 25 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 15 Oct 2015). 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 Mean Number of Nocturnal Voids Averaged Over a 3-Month Period (time frame: Day 1 (Baseline), Week 1, Months 1, 2, 3 (3-month double-blind treatment period)). 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?
On the ClinicalTrials.gov record for NCT01262456, 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 15 Oct 2015.