Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients
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
1 other identifier
interventional
395
2 countries
56
Brief 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.
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 Feb 2011
Shorter than P25 for phase_3
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 15, 2010
CompletedFirst Posted
Study publicly available on registry
December 17, 2010
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
October 15, 2015
CompletedOctober 15, 2015
September 1, 2015
11 months
December 15, 2010
June 18, 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 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.
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.
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
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
- +4 more secondary outcomes
Study Arms (3)
Desmopressin 50 μg Double-Blind / 100 μg Open-Label
EXPERIMENTALParticipants 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
EXPERIMENTALParticipants 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 COMPARATORParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
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
- 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
- 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Pinnacle Research Group, LLC
Anniston, Alabama, United States
Medical Affiliated Research Center, Inc.
Huntsville, Alabama, United States
Radiant Research, Inc.
Scottsdale, Arizona, United States
Premiere Pharmaceutical Research
Tempe, Arizona, United States
Family Medical Center
Foothill Rance, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Radiant Research, Inc.
Santa Rosa, California, United States
Genitourinary Surgical Consultants
Denver, Colorado, United States
Radiant Research, Inc.
Denver, Colorado, United States
Front Range Clinical Research, LLC
Wheat Ridge, Colorado, United States
Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, 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
Advanced Pharma CR, LLC
Miami, Florida, United States
DMI Research
Pinellas Park, Florida, United States
Pinellas Urology, Inc
St. Petersburg, Florida, United States
Midtown Medical Center
Tampa, Florida, United States
Advanced Research Institute, Inc.
Trinity, Florida, United States
Radiant Research, Inc.
Atlanta, Georgia, United States
Southeastern Medical Research Institute
Columbus, Georgia, United States
Radiant Research, Inc.
Chicago, Illinois, United States
Accelovance
Peoria, Illinois, United States
Accelovance
South Bend, Indiana, United States
FutureCare Studies, Inc.
Springfield, Massachusetts, United States
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States
Beyer Research
Kalmazoo, 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
Urology Center Research Institute
Englewood, New Jersey, United States
AccuMed Research Associates
Garden City, New York, United States
University Urology Associates
New York, New York, United States
Radiant Research, Inc.
Akron, Ohio, United States
Community Research
Cincinnati, Ohio, United States
Complete HealthCare
Columbus, Ohio, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, United States
Penn Urology
Philadelphia, Pennsylvania, United States
Hartwell Research Group, LLC
Anderson, South Carolina, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Radiant Research, Inc.
Greer, South Carolina, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Radiant Research Inc.
Dallas, Texas, United States
Quality Research Incorporated
San Antonio, Texas, United States
Radiant Research, Inc.
San Antonio, Texas, United States
Wilford Hall Medical Center
San Antonio, Texas, United States
Exemplar Research Inc.
Morgantown, West Virginia, United States
Can-Med Clinical Research, Inc.
Victoria, British Columbia, Canada
The Male/ Female Health and Research Centre
Barrie, Ontario, Canada
Urology Associates / Urologic Medical Research
Kitchener, Ontario, Canada
Investigational Site
North Bay, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Related Publications (1)
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.
PMID: 23454402RESULT
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
December 15, 2010
First Posted
December 17, 2010
Study Start
February 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
October 15, 2015
Results First Posted
October 15, 2015
Record last verified: 2015-09