Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) Clinical Trial
Official title:
A Randomized, Placebo-controlled Multi-center Clinical Trial to Evaluate the Efficacy and Safety of Pregabalin for the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Primary Objectives
1. To compare six (6) weeks of treatment with pregabalin versus placebo in CP/CPPS
participants with respect to the primary endpoint in the NIH-CPSI
2. To evaluate the safety and tolerability of six (6) weeks of pregabalin in CP/CPPS
participants
Design
Eligible participants will receive either pregabalin or placebo, randomly assigned at a
ratio of 2:1. Study treatment will be for 6 weeks with dose starting at 150mg going up to
300mg and finally to 600mg daily, to maximum tolerated dose. Participants will be advised to
take the study medication 3 times per day. There are 3 clinic visits and 2 telephone
contacts. Participants will be offered optional active treatment for an additional 6 weeks
at the end of the first 6 weeks. For those participating in both phases there are a total of
4 clinic visits and 5 telephone contacts.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment