Investigation of the Superiority Effect of Desmopressin to Placebo in Terms of Night Voids Reduction in Nocturia Adult Female Patients
COMFORT
A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablet for the Treatment of Nocturia in Adult Females
1 other identifier
interventional
268
2 countries
45
Brief Summary
A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the safety and efficacy of desmopressin oral melt tablets against placebo during 3 months of treatment in adult females with nocturia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2010
Shorter than P25 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 19, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedResults Posted
Study results publicly available
October 15, 2015
CompletedOctober 15, 2015
September 1, 2015
1 year
October 18, 2010
June 19, 2015
September 16, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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 endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints.
Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month 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 endpoint. The trial was to be declared positive only if the 25 μg desmopressin group had a statistically significant positive effect as compared to placebo on both co-primary endpoints.
Day 1 (Baseline); Week 1, Months 1, 2, 3 (3-month treatment period)
Secondary Outcomes (7)
Change From Baseline in Mean Number of Nocturnal Voids at Month 3
Day 1 (Baseline), Month 3
Adjusted Probability of Participants Achieving a >33% Reduction From Baseline in Number of Nocturnal Voids at Month 3
Day 1 (Baseline), Month 3
Change From Baseline in Mean Time to First Nocturnal Void at Month 3
Day 1 (Baseline), Month 3
Change From Baseline in Nocturnal Urine Volume at Month 3
Day 1 (Baseline), Month 3
Change From Baseline in 24-Hour Urine Volume at Month 3
Day 1 (Baseline), Month 3
- +2 more secondary outcomes
Study Arms (2)
Desmopressin 25 μg
EXPERIMENTALParticipants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
Placebo
PLACEBO COMPARATORParticipants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent prior to performance of any trial-related activity
- Female sex 18 years of age or older
- At least 2 voids every night in a consecutive 3-day period during the screening period
You may not qualify if:
- 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
- Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
- Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours)
- Central or nephrogenic diabetes insipidus
- Syndrome of inappropriate anti-diuretic hormone secretion
- Current or a history of urologic malignancies e.g. bladder 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Medical Affiliated Research Center Inc.
Huntsville, Alabama, United States
Radiant Research Inc.
Scottsdale, Arkansas, United States
Family Medical Center
Foothill Ranch, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Radiant Research Inc.
Santa Rosa, California, United States
Downtown Woman's Health Care
Denver, Colorado, United States
Front Range Clinical Research
Wheat Ridge, Colorado, United States
South Florida Medical Research
Aventura, Florida, United States
Women's Medical Research Group, LLC
Clearwater, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
FPA Clinical Research
Kissimmee, Florida, United States
Sunrise Medical Research
Lauderdale Lakes, Florida, United States
DMI Research
Pinellas Park, Florida, United States
Southeastern Institute
Columbus, Georgia, United States
Southeastern Medical Research Institute
Columbus, Georgia, United States
Radiant Research Inc.
Chicago, Illinois, United States
NorthShore University HealthSystem
Evanston, Illinois, United States
Accelovance
Peoria, Illinois, United States
Accelovance
South Bend, Indiana, United States
FutureCare Studies
Springfield, Massachusetts, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Beyer Research
Paw Paw, Michigan, United States
Remedica, LLC
Rochester, Michigan, United States
Radiant Research, Inc.
Edina, Minnesota, United States
Radiant Research, Inc.
St Louis, Missouri, United States
Radiant Research
Las Vegas, Nevada, United States
Anderson & Collins Clinical Research Inc
Edison, New Jersey, United States
ACCUMED Research Associates
Garden City, New York, United States
Center for Urologic Research of WNY, LLC
Williamsville, New York, United States
Radiant Research, Inc.
Akron, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Complete HealthCare for Women
Columbus, Ohio, United States
HWC Women's Research Center
Englewood, Ohio, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, United States
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, United States
Radiant Research, Inc.
Greer, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Radiant Research Inc.
Dallas, Texas, United States
Quality Research, Inc.
San Antonio, Texas, United States
Radiant Research, Inc.
San Antonio, Texas, United States
Exemplar Research Inc.
Morgantown, West Virginia, United States
CanMed Clinical Research Inc.
Victoria, British Columbia, Canada
The Male/Female Health Research Center
Barrie, Ontario, Canada
Urology Associates/Urologic Medical Research
Kitchener, Ontario, Canada
Investigational site
North Bay, Ontario, Canada
Related Publications (2)
Sand PK, Dmochowski RR, Reddy J, van der Meulen EA. Efficacy and safety of low dose desmopressin orally disintegrating tablet in women with nocturia: results of a multicenter, randomized, double-blind, placebo controlled, parallel group study. J Urol. 2013 Sep;190(3):958-64. doi: 10.1016/j.juro.2013.02.037. Epub 2013 Feb 20.
PMID: 23454404RESULTJuul KV, Malmberg A, van der Meulen E, Walle JV, Norgaard JP. Low-dose desmopressin combined with serum sodium monitoring can prevent clinically significant hyponatraemia in patients treated for nocturia. BJU Int. 2017 May;119(5):776-784. doi: 10.1111/bju.13718. Epub 2016 Dec 10.
PMID: 27862898DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Development Support
- Organization
- Ferring Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Development Support
Ferring Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 19, 2010
Study Start
November 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
October 15, 2015
Results First Posted
October 15, 2015
Record last verified: 2015-09