Clinical Trial: Trial Investigating the Long Term Safety and Tolerability of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multi-Centre Trial Investigating the Long Term Safety and Tolerability of Desmopressin (FE 992026) Orally Disintegrating Tablets for the Treatment of Nocturia Due to Nocturnal
Brief Summary: Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year
Detailed Summary:
Sponsor: Ferring Pharmaceuticals
Current Primary Outcome:
- The frequency and severity of adverse events [ Time Frame: Up to 1 year ]During long-term treatment
- Clinically significant changes in laboratory values and vital signs [ Time Frame: Up to 1 year ]During long-term treatment
- The incidence and severity of hyponatraemia [ Time Frame: Up to 1 year ]Measured by serum sodium levels during long-term treatment
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in mean number of nocturnal voids [ Time Frame: Week 12, 24, 40 and 52 ]
- Change from baseline in mean time to first awakening to void [ Time Frame: Week 12, 24, 40 and 52 ]
- Change from baseline in mean nocturnal urin volume [ Time Frame: Week 12, 24, 40 and 52 ]
- Change from baseline in mean Nocturnal Polyuria Index (NPI) [ Time Frame: Week 12, 24, 40 and 52 ]
- Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) [ Time Frame: Week 12, 24, 40 and 52 ]
- Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: Week 12, 24, 40 and 52 ]
- Change from baseline in bother score [ Time Frame: Week 12, 24, 40 and 52 ]Assessed by the Hsu 5-point Likert bother scale
Original Secondary Outcome: Same as current
Information By: Ferring Pharmaceuticals
Dates:
Date Received: February 9, 2017
Date Started: January 11, 2017
Date Completion: September 30, 2018
Last Updated: May 2, 2017
Last Verified: May 2017