Status:
COMPLETED
An Extension Study Investigating the Efficacy and Safety of a Fast-Dissolving ("Melt") Formulation of Desmopressin for the Treatment of Nocturia in Adults
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Nocturia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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.
Detailed Description
FE992026 CS31 was a multicenter open-label extension study for patients who were enrolled in Study FE992026 CS29 (NCT00477490) and had completed at least Visit 3E in Part II of that study. The CS29 s...
Eligibility Criteria
Inclusion
- Written informed consent prior to the performance of any study-related activity.
- Was randomized into Part II of Protocol FE992026 CS29 (NCT00477490), entitled "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" and have completed at least Visit 3E in Part II (Day 15).
Exclusion
- Patients using loop diuretics (furosemide, torsemide, ethacrynic acid).
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT00615836
Start Date
December 1 2007
End Date
May 1 2010
Last Update
December 15 2015
Active Locations (73)
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1
Radiant Research
Scottsdale, Arizona, United States, 85251
2
Arkansas Primary Care Clinic, PA
Little Rock, Arkansas, United States, 72204
3
Advanced Urology Medical Center
Anaheim, California, United States, 92801
4
Impact Clinical Trials
Beverly Hills, California, United States, 90211