Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-Center Study With a Double Blind Extension Investigating the Efficacy and Safety of a Fast- Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
1 other identifier
interventional
799
2 countries
80
Brief Summary
The purpose of this study is to investigate the efficacy and safety of several doses of the melt formulation of desmopressin in a broad population of adult patients with nocturia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2007
Shorter than P25 for phase_3
80 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
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 22, 2007
CompletedFirst Posted
Study publicly available on registry
May 23, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
November 2, 2015
CompletedNovember 2, 2015
September 1, 2015
9 months
May 22, 2007
June 16, 2015
September 29, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4
The number of nocturnal voids was the average over 3 consecutive 24-hours periods prior to Day 1 and prior to the week 4 visit as recorded in participant diaries. This was the first co-primary outcome.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4
Percentage of participants in each treatment arm that had a greater than 33% reduction from baseline to the end of Part I (week 4) in mean number of nocturnal voids. Nocturnal void data were recorded in participant diaries. This was the second co-primary outcome.
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Secondary Outcomes (10)
Part II: Change From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
Part II: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids to Days 29, 57, 113 and 169
- Week 3 to Day 1 (Baseline), Days 29, 57, 113 and 169
Part I: Change From Baseline in Total Reported Sleep Time at Week 4
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in Initial Period of Undisturbed Sleep at Week 4
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
Part I: Change From Baseline in Quality of Life Assessed by The International Consultation on Incontinence Modular Questionnaire - Nocturia (ICIQ-N) at Week 4
- Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
- +5 more secondary outcomes
Study Arms (5)
Placebo
PLACEBO COMPARATORParticipants took a placebo 'melt' for 28 days to complete part 1 of the study. In part 2, placebo patients were randomized to one of the other 4 treatment arms based on assignments predetermined at the initial randomization, to receive active desmopressin melt for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
desmopressin melt 10 μg
EXPERIMENTALParticipants took desmopressin melt 10 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
desmopressin melt 25 μg
EXPERIMENTALParticipants took desmopressin melt 25 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
desmopressin melt 50 μg
EXPERIMENTALParticipants took desmopressin melt 50 μg for 28 days to complete part 1 of the study. Participants continued on this dose in part 2 of the study for between 1 and 6 months (until the database for part 1 was locked and treatment was unblinded).
desmopressin melt 100 μg
EXPERIMENTALParticipants will take desmopressin melt 100 μg for 28 days to complete part 1 of the study. Participants will continue on this dose in part 2 of the study for between 1-6 months (until the database for part 1 is locked and treatment is unblinded).
Interventions
Oral lyophilisate of desmopressin acetate placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime in the assigned dosage: 10, 25, 50 or 100 μg
Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.
Eligibility Criteria
You may qualify if:
- Written informed consent prior to the performance of any study-related activity.
- Patients 18 years and older with an average of ≥ 2 nocturnal voids per night as determined by a 3 day frequency-volume chart during the screening period.
You may not qualify if:
- Males:
- Clinical suspicion of bladder outlet obstruction and/or urine flow \< 5 ml/s. If medical history and/or physical examination suggest bladder outlet obstruction, uroflowmetry should be performed to confirm the diagnosis
- Surgical treatment for bladder outlet obstruction/benign prostatic hyperplasia performed within the past 6 months
- Females:
- Pregnancy. Females of reproductive age must have documentation of a reliable method of contraception.
- Use of pessary for pelvic prolapse.
- Unexplained pelvic mass.
- Males and Females:
- Clinical suspicion of urinary retention and/or post void residual volume \> 150 ml. If medical history and/or physical examination suggest urinary retention, bladder ultrasound or catheterization should be performed to confirm the diagnosis.
- Current or past urologic malignancy (e.g., bladder cancer, prostate cancer).
- Clinical evidence of current genitourinary tract pathology that could interfere with voiding.
- History of neurogenic detrusor activity (previously known as detrusor hyperreflexia).
- Suspicion or evidence of cardiac failure.
- Uncontrolled hypertension.
- Uncontrolled diabetes mellitus.
- +25 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
Radiant Research
Birmingham, Alabama, 35209, United States
Radiant Research
Scottsdale, Arizona, 85251, United States
Arkansas Primary Care Clinic
Little Rock, Arkansas, 72204, United States
Advanced Urology Medical Center
Anaheim, California, 92801, United States
Impact Clinical Trials
Beverly Hills, California, 90211, United States
Atlantic Urology Medical Group
Long Beach, California, 90806, United States
California Professional Research
Newport Beach, California, 92660, United States
San Diego Uro-Research
San Diego, California, 92103, United States
Radiant Research
Santa Rosa, California, 95404, United States
West Coast Clinical Research
Tarzana, California, 91356, United States
Western Clinical Research
Torrance, California, 90505, United States
Urology Associates PC
Denver, Colorado, 80210, United States
Downtown Women's Health Care
Denver, Colorado, 80218, United States
Genitourinary Surgical Consultants
Denver, Colorado, 80220, United States
Connecticut Clinical Research Center, LLC
Middlebury, Connecticut, 06762, United States
South Florida Medical Research
Aventura, Florida, 33180, United States
Women's Medical Research Group, LLC
Clearwater, Florida, 33759, United States
Medsearch Professional Group
Miami, Florida, 33145, United States
Sunrise Medical Research
Plantation, Florida, 33324, United States
Radiant Research
Stuart, Florida, 34996, United States
Southeastern Research Group, Inc.
Tallahassee, Florida, 32308, United States
Tampa Bay Urology
Tampa, Florida, 33607, United States
Radiant Research
West Palm Beach, Florida, 33407, United States
Southeastern Medical Research Institute
Columbus, Georgia, 31904, United States
Investigational site - PC
Dunwoody, Georgia, 30338, United States
Accelovance
Peoria, Illinois, 61602, United States
Radiant Research, Kansas City
Overland Park, Kansas, 66202, United States
Benchmark Research
Metairie, Louisiana, 70006, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106, United States
Pierremont Women's Clinic
Shreveport, Louisiana, 71111, United States
FutureCare Studies, Inc.
Springfield, Massachusetts, 01103, United States
Radiant Research Inc.
St Louis, Missouri, 63141, United States
Women's Clinic of Lincoln, P.C
Lincoln, Nebraska, 68510, United States
Investigational site
Las Vegas, Nevada, 89109, United States
AdvanceMed Research
Lawrenceville, New Jersey, 08648, United States
Lawrenceville Urology
Lawrenceville, New Jersey, 08648, United States
Morristown Urology
Morristown, New Jersey, 07960, United States
Urology Group of New Mexico, PC
Albuquerque, New Mexico, 87109, United States
Upstate Urology
Albany, New York, 12206, United States
Investigational site - Adult & Pediatric Urology
Carmel, New York, 10512, United States
AccuMed Research Associates
Garden City, New York, 11530, United States
University Urology Associates
New York, New York, 10016, United States
Ferring Pharmaceutical Inc
Suffern, New York, 10901, United States
Northeast Urology Research
Concord, North Carolina, 28025, United States
PharmQuest
Greensboro, North Carolina, 27401, United States
New Hanover Medical Research
Wilmington, North Carolina, 28401, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, 27103, United States
Radiant Research
Cincinnati, Ohio, 45249, United States
Radiant Research - Akron
Mogadore, Ohio, 44260, United States
Urologic Consultants of SE PA
Bala-Cynwyd, Pennsylvania, 19004, United States
Philadelphia Clinical Research, LLC
Philadelphia, Pennsylvania, 19114, United States
Radiant Research
Philadelphia, Pennsylvania, 19115, United States
Advanced Clinical Concepts
Reading, Pennsylvania, 19611, United States
University Medical Group
Greenville, South Carolina, 29605, United States
Radiant Research, Greer
Greer, South Carolina, 29651, United States
Palmetto Medical Research
Mt. Pleasant, South Carolina, 29464, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Advanced Research Associates
Corpus Christi, Texas, 78414, United States
Health Central Women's Care
Dallas, Texas, 75231, United States
Accelovance
Houston, Texas, 77024, United States
Regional Medical Center and Diagnostic
Humble, Texas, 77338, United States
Radiant Research San Antonio
San Antonio, Texas, 78228, United States
Urology San Antonio Research, PA
San Antonio, Texas, 78229, United States
Virginia Urology Center
Richmond, Virginia, 23235, United States
Urology of Virginia PC
Virginia Beach, Virginia, 23454, United States
Women's Clinical Research Center
Seattle, Washington, 98105, United States
Investigational site - Medical Professional
Seattle, Washington, 98166, United States
Seattle Urology Research Center
Seattle, Washington, 98166, United States
Southern Interior Medical Center
Kelowna, British Columbia, V1Y-2H4, Canada
Can-Med Clinical Research Inc.
Victoria, British Columbia, V8T 5G1, Canada
Investigational site - Clinical Research
Victoria, British Columbia, V8V 3N1, Canada
Investigational site - Professional Corporation
Fredericton, New Brunswick, E3B 5B8, Canada
The Male/Female Health and Reserach
Barrie, Ontario, L4M 7G1, Canada
Brantford Urology Research
Brantford, Ontario, N3R 4N3, Canada
Guelph Urology Associates
Guelph, Ontario, N1H 5J1, Canada
Investigational site
North Bay, Ontario, P1B 4Z2, Canada
The Fe/Male Health Centres
Oakville, Ontario, L6H 3P1, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
Related Publications (5)
Juul KV, Klein BM, Norgaard JP. Long-term durability of the response to desmopressin in female and male nocturia patients. Neurourol Urodyn. 2013 Apr;32(4):363-70. doi: 10.1002/nau.22306. Epub 2012 Sep 12.
PMID: 22972524BACKGROUNDWeiss JP, Zinner NR, Klein BM, Norgaard JP. Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial. Neurourol Urodyn. 2012 Apr;31(4):441-7. doi: 10.1002/nau.22243. Epub 2012 Mar 22.
PMID: 22447415RESULTJuul 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: 27862898DERIVEDBliwise DL, Holm-Larsen T, Goble S. Increases in duration of first uninterrupted sleep period are associated with improvements in PSQI-measured sleep quality. Sleep Med. 2014 Oct;15(10):1276-8. doi: 10.1016/j.sleep.2014.05.013. Epub 2014 Jun 13.
PMID: 25172115DERIVEDJuul KV, Klein BM, Sandstrom R, Erichsen L, Norgaard JP. Gender difference in antidiuretic response to desmopressin. Am J Physiol Renal Physiol. 2011 May;300(5):F1116-22. doi: 10.1152/ajprenal.00741.2010. Epub 2011 Mar 2.
PMID: 21367921DERIVED
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
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2007
First Posted
May 23, 2007
Study Start
May 1, 2007
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
November 2, 2015
Results First Posted
November 2, 2015
Record last verified: 2015-09