CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 324 enrolled
Drug / intervention
Pregabalin +1 moredrug
Likely dose
Pregabalin 150 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00371033
NCT00371033Phase 3Completed

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)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Sep 1, 2006·Updated Sep 22, 2025

In Brief

A Phase 3 clinical trial evaluating Pregabalin and Placebo for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS). Completed, enrolled 324 participants across 11 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2006
Enrollment StartMar 1, 2006
Primary CompletionJan 1, 2008
Study CompletionApr 30, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.8 years ago

Interventions

Pregabalindrug

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.

Placebodrug

Placebo at same frequency as pregabablin