NCT01613586

A Randomized Study Comparing Placebo and ASP3652 in the Treatment of Women With Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC)

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Adaptive, Combined Proof of Concept and Dose-Finding Study to Investigate Efficacy, Safety, Pharmacodynamics and Pharmacokinetics of ASP3652 in the Treatment of Female Patients With Bladder Pain Syndrome / Interstitial Cystitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Astellas Pharma Europe B.V. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study several dose levels of ASP3652, given orally for 12 weeks, will be compared with placebo in the treatment of female patients with Bladder Pain Syndrome / Interstitial Cystitis.

Detailed description

This study consists of a screening phase, an initial 3 weeks Run-in period, a 12 weeks Treatment period and a 2 weeks Follow-up (FU) period. This study will investigate the efficacy and safety of a 12 week treatment with ASP3652 in female patients with Bladder Pain Syndrome / Interstitial Cystitis (BPS/IC). Different dose levels of ASP3652 will be compared with placebo. ASP3652 is administered as oral tablets. The objectives of the study are to investigate efficacy of ASP3652 in patients with BPS/IC, to assess the optimal dose of ASP3652, to investigate safety and tolerability and to investigate pharmacokinetics and pharmacodynamics of ASP3652 in patients with BPS/IC in an out-patient setting.

Conditions

• Cystitis, Interstitial
• Urinary Bladder Disease
• Pain
• Urologic Diseases

Interventions

Type	Name	Description
DRUG	ASP3652	Oral
DRUG	Placebo	Oral

Timeline

• Start date: 2012-05-31
• Primary completion: 2014-03-18
• Completion: 2014-03-18
• First posted: 2012-06-07
• Last updated: 2024-11-05

Locations

60 sites across 12 countries: Belgium, Czechia, Denmark, Germany, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Russia, Spain