Study of Minirin Melt® in Adult Patients With Nocturia
Terminated
- Conditions
- Nocturia
- Registration Number
- NCT03089073
- Lead Sponsor
- Ferring Pharmaceuticals
- Brief Summary
Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 835
Inclusion Criteria
- Adult aged between 19 and 65 years
- Patients having nocturia
- Decision made to prescribe Minirin Melt according to prescription information
- Willingness and ability to provide written informed consent
Exclusion Criteria
- When patients have habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24hours)
- When patients have a history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuresis
- When patients have moderate and severe renal insufficiency (creatinine clearance below 50ml/min)
- When patients have known hyponatremia
- When patients have secretion Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH)
- When patients have hypersensitivity to the active substances or to any of the excipients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in mean number of nocturnal voids Baseline and treatment-related visits up to 3 months Calculated by 72 hour frequency volume chart (FVC)
- Secondary Outcome Measures
Name Time Method Reduction from baseline in the mean number of nocturnal voids Baseline and treatment-related visits up to 3 months Assessed as a (50% decrease) or reduction of nocturnal diuresis (\>20%)
Trial Locations
- Locations (1)
Daegu Fatima Hospital (there may be other sites in this country)
🇰🇷Daegu, Korea, Republic of