Clinical Trial: Study of Minirin Melt® in Adult Patients With Nocturia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Non-interventional Study on Safety and Efficacy of Minirin Melt® in Adult Patients With Nocturia

Brief Summary: Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia

Detailed Summary:
Sponsor: Ferring Pharmaceuticals

Current Primary Outcome: Change from baseline in mean number of nocturnal voids [ Time Frame: Baseline and treatment-related visits up to 3 months ]

Calculated by 72 hour frequency volume chart (FVC)


Original Primary Outcome: Same as current

Current Secondary Outcome: Reduction from baseline in the mean number of nocturnal voids [ Time Frame: Baseline and treatment-related visits up to 3 months ]

Assessed as a (50% decrease) or reduction of nocturnal diuresis (>20%)


Original Secondary Outcome: Same as current

Information By: Ferring Pharmaceuticals

Dates:
Date Received: March 20, 2017
Date Started: July 13, 2015
Date Completion: May 30, 2019
Last Updated: April 10, 2017
Last Verified: April 2017