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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
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.
Details
| Lead sponsor | Ferring Pharmaceuticals |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 799 |
| Start date | 2007-05 |
| Completion | 2008-02 |
Conditions
- Nocturia
Interventions
- desmopressin acetate
- Placebo
Primary outcomes
- Part I: Change From Baseline in Mean Number of Nocturnal Voids at Week 4 — - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
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. - Part I: Percentage of Participants With Greater Than 33 Percent Reduction From Baseline in Mean Number of Nocturnal Voids at Week 4 — - Week 3 to Day 1 (Baseline), Week 4 (end of Part I)
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.
Countries
United States, Canada