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NCT00615836 · ClinicalTrials.gov registry record · Phase 3
An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
A Phase 3 study of Nocturia, sponsored by Ferring Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 554
- Enrollment target
- 20
- Study locations
NCT00615836: Completed Phase 3 study of Nocturia, sponsored by Ferring Pharmaceuticals.
NCT00615836 is a Phase 3 study of Nocturia that has completed, run by Ferring Pharmaceuticals. The registered enrollment target is 554 participants, above the 255-participant average among 9 other Nocturia trials with a reported enrollment target (117% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00615836, a Phase 3 study of Nocturia, has completed, sponsored by Ferring Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 554 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to investigate the long term efficacy and safety of several doses of the Melt formulation of desmopressin in a broad population of adult patients with nocturia.
Primary Outcome
Participants completed a voiding diary for 3 consecutive 24-hour periods prior to the study visit in which they recorded each nocturnal urination (void). The mean number of voids per night was the average number of voids from the 3-day diary. Baseline refers to Baseline of Study CS29 and the number of weeks represents the total exposure to study drug. Participants in the 10μg arm are included only until the time of dose escalation.
Conditions Studied
Interventions
- DRUG Desmopressin Melt
Study Locations (20)
California
- Advanced Urology Medical Center - Anaheim
- Impact Clinical Trials - Beverly Hills
- California Professional Research - Newport Beach
- San Diego Uro-Reseach - San Diego
- Radiant Research - Santa Rosa
- West Coast Clinical Research - Tarzana
- Western Clinical Research - Torrance
Florida
- South Florida Medical Research - Aventura
- Women's Health Research Group, LLC - Clearwater
- Radiant Research - St. Petersburg - Pinellas Park
- Sunrise Medical Research - Plantation
- Radiant Research - Stuart
- Tampa Bay Urology - Tampa
- Radiant Research - West Palm Beach
Colorado
- Urology Associates PC - Denver
- Downtown Women's Health Care - Denver
- Genitourinary Surgical Consultants - Denver
Arizona
- Radiant Research - Scottsdale
Arkansas
- Arkansas Primary Care Clinic, PA - Little Rock
Connecticut
- Connecticut Clinical Research Center, LLC - Middlebury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 554 participants |
| Start Date | 2007-12 |
| Est. Completion | 2010-05 |
| Phase | Phase 3 |
What the finished NCT00615836 record still lists
NCT00615836 is an interventional study that assigns participants to a tested intervention. The registered 554 participants enrollment target is mid-sized for trials with a published cap, above the 255-participant average among 9 other Nocturia trials with a reported enrollment target (117% higher).
The record links to 1 condition, with Nocturia appearing as the primary indexed condition, and to 1 intervention - of which Desmopressin Melt is the first listed.
NCT00615836 names 20 study sites across 6 states, led by California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT00615836 about?
NCT00615836 is a clinical study titled "An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults". The purpose of this study was to investigate the long term efficacy and safety of several doses of the Melt formulation of desmopressin in a broad population of adult patients with nocturia.
What is the current status of trial NCT00615836?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 554 participants. The study started on 2007-12. Estimated completion is 2010-05.
What conditions does trial NCT00615836 study?
This clinical trial studies the following conditions: Nocturia.
What interventions are being tested in trial NCT00615836?
The interventions under investigation include: Desmopressin Melt (DRUG).
Who is sponsoring clinical trial NCT00615836?
This trial is sponsored by Ferring Pharmaceuticals, which has 83 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00615836 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Nocturia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00615836's enrollment target sits among peer trials
554 3rd of 9 higher than 7 of 9 other Nocturia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Nocturia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia
COMPLETED · Phase 3
-
Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary
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-
Long Term Safety Assessment of SER120 in Patients With Nocturia
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Mandibular Advancement Device and Changes in Nocturia
RECRUITING · NA
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Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A
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Multi-center Trial to Improve Nocturia and Sleep in Older Adults
RECRUITING · NA
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