NCT00371033

Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.

Detailed description

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.

Conditions

• Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)

Interventions

Type	Name	Description
DRUG	Pregabalin	Pregabalin 150 mg/d (50 mg orally 3 times daily) for 2 weeks, then 300 mg/d (100 mg orally 3 times daily) for 2 weeks, and then 600 mg/d (200 mg orally 3 times daily) for 2 weeks.
DRUG	Placebo	Placebo at same frequency as pregabablin

Timeline

• Start date: 2006-03-01
• Primary completion: 2008-01-01
• Completion: 2008-04-30
• First posted: 2006-09-01
• Last updated: 2025-09-22
• Results posted: 2025-09-22

Locations

11 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study