NCT03702777

A Study of ASP8302 in Participants With Underactive Bladder

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2a, Proof-of-Concept Study of ASP8302 in Subjects With Underactive Bladder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study objectives of this study are to evaluate the efficacy of ASP8302 compared with placebo in participants with underactive bladder (UAB), to investigate the safety and tolerability of ASP8302 compared with placebo in participants with UAB, to investigate the pharmacokinetics of ASP8302 in participants with UAB and to support the development of the UAB - Patient Reported Outcome (PRO).

Detailed description

The study will comprise a screening visit, followed by a treatment period and a 2-week follow-up period, in total 8 weeks. Participants will visit the clinic at screening (visit 1) and every 2 weeks (visit 2, 3, 4, and 5). During the course of the study assessments will be performed at the visits.

Conditions

• Underactive Bladder

Interventions

Type	Name	Description
DRUG	ASP8302	Oral Capsule
DRUG	Placebo	Oral Capsule

Timeline

• Start date: 2018-11-20
• Primary completion: 2020-04-28
• Completion: 2020-04-28
• First posted: 2018-10-11
• Last updated: 2024-11-21

Locations

29 sites across 6 countries: Germany, Japan, Netherlands, Poland, Slovakia, United Kingdom