NCT01262456

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 395 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nocturia

Interventions

Type	Name	Description
DRUG	Desmopressin
DRUG	Placebo

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-12-17
• Last updated: 2015-10-15
• Results posted: 2015-10-15

Locations

56 sites across 2 countries: United States, Canada