A Clinical Study to Investigate the Efficacy, Safety and Pharmacokinetics of ASP3652 in Patients With Chronic Abacterial Prostatitis / Chronic Pelvic Pain Syndrome (CP/CPPS)

Summary

In this study several doses of ASP3652, given orally for 12 weeks, will be compared with placebo in the treatment of patients with Chronic abacterial Prostatitis / Chronic Pelvic Pain Syndrome.

Timeline

Start

2011-06

Primary completion

2013-02

Completion

2013-02

Outcome

Missed primary endpoint

paper During the execution phase the study was stopped early, that is 32% less than planned maximum sample size, due to futility. PMID 30178528 ↗

paper This resulted in the early stopping of a trial recruiting patients on ineffective treatment. PMID 30178528 ↗

Publications

• Martina R, Houbiers J, Melis J, van Till O. A combined proof of concept and dose finding study with multiple endpoints: A Bayesian adaptive design in chronic prostatitis/chronic pelvic pain syndrome. Biom J. 2019 May;61(3):476-487. doi: 10.1002/bimj.201700210. Epub 2018 Sep 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP3652	Unknown	—	Oral

Indications