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NCT00371033 · ClinicalTrials.gov registry record · Phase 3
Efficacy & Safety Study of Pregabalin to Treat Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
A Phase 3 study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 324
- Enrollment target
- 11
- Study locations
NCT00371033: Completed Phase 3 study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00371033 is a Phase 3 study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 324 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). The trial reports 11 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00371033, a Phase 3 study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS), has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 324 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this study is to determine whether pregabalin is an effective treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome.
Primary Outcome
Decrease (improvement) in the National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) score of at least 6 points from baseline to week 6. The NIH-CPSI measures the 3 key domains of CP/CPPS: pain (location, frequency, and severity; possible score, 0-21), urinary symptoms (irritative and obstructive; possible score, 0-10), and impact/quality of life (possible score, 0-12), for a total possible score of 0 to 43. A 6-point decrease in NIHCPSI score has been shown to be clinically
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pregabalin
Study Locations (11)
California
- Charles R Drew University of Medicine & Science - Los Angeles
- David Geffen School of Medicine at UCLA - Los Angeles
- Stanford University Medical Center - Stanford
Illinois
- Northwestern University Feinberg School of Medicine - Chicago
Maryland
- University of Maryland - Baltimore
Massachusetts
- Harvard Medical School - Boston
Mississippi
- University of Mississippi Medical Center - Jackson
Ohio
- Cleveland Clinic Foundation - Cleveland
Pennsylvania
- Temple University School of Medicine - Philadelphia
Washington
- University of Washington Harborview Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-04-30 |
| Phase | Phase 3 |
What the finished NCT00371033 record still lists
NCT00371033 is an interventional study that assigns participants to a tested intervention. The registered 324 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00371033 lists 11 locations in 9 states (California, Illinois, Maryland).
Frequently Asked Questions
What is clinical trial NCT00371033 about?
NCT00371033 is a clinical study titled "Efficacy & Safety Study of Pregabalin to Treat 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.
What is the current status of trial NCT00371033?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 324 participants. The study started on 2006-03. Estimated completion is 2008-04-30.
What conditions does trial NCT00371033 study?
This clinical trial studies the following conditions: Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS).
What interventions are being tested in trial NCT00371033?
The interventions under investigation include: Placebo (DRUG), Pregabalin (DRUG).
Who is sponsoring clinical trial NCT00371033?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00371033 being conducted?
This trial has 11 study locations across California, Illinois, Maryland, Massachusetts, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00371033's enrollment target sits among peer trials
324 1079th of 2000 higher than 920 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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