Pain Clinical Trial
Official title:
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
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.
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.
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