Trial Investigating the Long Term Safety and Tolerability of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Subjects
Phase 3
Completed
- Conditions
- Nocturia
- Interventions
- Registration Number
- NCT03051009
- Lead Sponsor
- Ferring Pharmaceuticals
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 503
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Desmopressin ODT 25 μg (female previous on 25 μg) Desmopressin ODT 25 μg Subjects received 25 μg in trial 000129. Desmopressin ODT 25 μg (female) Desmopressin ODT 25 μg New female subjects Desmopressin ODT 25 μg (female previously on placebo) Desmopressin ODT 25 μg Subjects received placebo in trial 000129 Desmopressin ODT 50 μg (male previous on 50 μg) Desmopressin ODT 50 μg Subjects received 50 μg in trial 000130 Desmopressin ODT 50 μg (male previous on placebo) Desmopressin ODT 50 μg Subjects received placebo in trial 000130 Desmopressin ODT 50 μg (male) Desmopressin ODT 50 μg New male subjects Desmopressin ODT 25 μg (male) Desmopressin ODT 25 μg Subjects received placebo in trial 000130 Desmopressin ODT 25 μg (male previous on 25 μg) Desmopressin ODT 25 μg Subjects received 25 μg in trial 000130
- Primary Outcome Measures
Name Time Method The frequency and severity of adverse events Up to 1 year During long-term treatment
Clinically significant changes in laboratory values and vital signs Up to 1 year During long-term treatment
The incidence and severity of hyponatraemia Up to 1 year Measured by serum sodium levels during long-term treatment
- Secondary Outcome Measures
Name Time Method Change from baseline in Insomnia Severity Index (ISI) Week 12, 24, 40 and 52 Change from baseline in mean number of nocturnal voids Week 12, 24, 40 and 52 Change from baseline in mean time to first awakening to void Week 12, 24, 40 and 52 Change from baseline in mean nocturnal urin volume Week 12, 24, 40 and 52 Change from baseline in mean Nocturnal Polyuria Index (NPI) Week 12, 24, 40 and 52 Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL) Week 12, 24, 40 and 52 Change from baseline in bother score Week 12, 24, 40 and 52 Assessed by the Hsu 5-point Likert bother scale
Trial Locations
- Locations (1)
Investigational site (there may be other sites in this country)
🇯🇵Tokyo, Japan