NCT01552343

Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary

A Double-blind, Randomized, Placebo-controlled Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess psychometric properties (reliability and validity) of the Nocturia Impact (NI) diary. To assess the association between reduction of number of nocturnal voids and the mean changes in NI scores (sensitivity of the NI total score to change in nocturia). To assess which NI diary items account for the main difference in change in total NI score in treatment versus placebo.

Conditions

• Nocturia

Interventions

Type	Name	Description
DRUG	Desmopressin	Desmopressin orally disintegrating tablets. Female participants took a 25 μg tablet and male participants took a 75 μg tablet one hour prior to bedtime for one month.
DRUG	Placebo	Placebo to match the 25 μg tablet of active drug taken by female participants or the 75 μg tablet taken by males. One placebo tablet taken one hour prior to bedtime for one month.

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2012-03-13
• Last updated: 2017-07-11
• Results posted: 2017-05-05

Locations

10 sites across 1 country: United States