Clinical Trial: Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Female Subjects
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Randomised, Double-blind, Placebo-controlled, Multi-centre Trial Investigating the Efficacy and Safety of Desmopressin (FE 992026) Orally Disintegrating Tablets During 12 Weeks of Treatment for Noct
Brief Summary: The purpose of this trial is to demonstrate efficacy of desmopressin ODT against placebo for the treatment of female subjects with nocturia due to nocturnal polyuria, during 12 weeks of treatment.
Detailed Summary:
Sponsor: Ferring Pharmaceuticals
Current Primary Outcome: Change from baseline in mean number of nocturnal voids during 12 weeks of treatment [ Time Frame: Week 1, 4, 8 and 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in mean time to first awakening to void [ Time Frame: Week 1, 4, 8 and 12 ]Assessed by the 3-day voiding diary
- Change from baseline in mean nocturnal urine volume [ Time Frame: Week 1, 4, 8 and 12 ]Assessed by the 3-day voiding diary
- Change from baseline in mean Nocturnal Polyuria Index (NPI) [ Time Frame: Week 1, 4, 8 and 12 ]Assessed by the 3-day voiding diary
- Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) [ Time Frame: Week 8 and 12 ]
- Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: Week 8 and 12 ]
- Change from baseline in bother score [ Time Frame: Week 8 and 12 ]Assessed by the Hsu 5-point Likert bother scale
- Frequency and severity of adverse events [ Time Frame: From screening to week 12 ]
Original Secondary Outcome: Same as current
Information By: Ferring Pharmaceuticals
Dates:
Date Received: September 14, 2016
Date Started: September 2016
Date Completion: September 2017
Last Updated: May 2, 2017
Last Verified: May 2017