NCT00477490

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 799 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nocturia

Interventions

Type	Name	Description
DRUG	desmopressin acetate	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
DRUG	Placebo	Oral placebo placed under the participant's tongue, without water, once daily approximately 1 hour before bedtime.

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2007-05-23
• Last updated: 2015-11-02
• Results posted: 2015-11-02

Locations

80 sites across 2 countries: United States, Canada