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NCT00103402 · ClinicalTrials.gov registry record · Phase 3
Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome
A Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 3
- Development phase
- 272
- Enrollment target
NCT00103402: Completed Phase 3 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT00103402 is a Phase 3 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 272 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00103402, a Phase 3 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 272 participants
- Enrollment target
Study Summary
The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg capsule), FDA approved medication for an indication in benign prostatic hyperplasia (BPH). The effectiveness of alfuzosin in improving lower urinary tract symptoms in patients with BPH has been documented in a number of placebo-controlled studies. A number of small studies have also suggested that alfuzosin ameliorates CP/CPPS symptoms through a similar alpha-blockade mechanism. This study will enable further testing of this hypothesis
Primary Outcome
For the National Institutes of Health Chronic Prostatitis Symptom Index (NIHCPSI) total score, higher scores indicate more severe symptoms and scores range from 0 to 43. The primary outcome was a decline of at least 4 from baseline to 12 weeks
Interventions
- DRUG Placebo
- DRUG Alfuzosin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2005-02 |
| Est. Completion | 2008-01 |
| Phase | Phase 3 |
What the finished NCT00103402 record still lists
NCT00103402 is an interventional study that assigns participants to a tested intervention. The registered 272 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 (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00103402 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00103402 about?
NCT00103402 is a clinical study titled "Trial to Compare Alfuzosin Versus Placebo in the Treatment of Chronic Prostatitis/Chronic Pelvic Pain Syndrome". The purpose of this randomized clinical trial is to evaluate the efficacy and safety of the alpha adrenergic blocker Alfuzosin (Uroxatral) in men with relatively new onset of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Alfuzosin is a once daily (10 mg capsule), FDA approved medicatio...
What is the current status of trial NCT00103402?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 272 participants. The study started on 2005-02. Estimated completion is 2008-01.
What interventions are being tested in trial NCT00103402?
The interventions under investigation include: Placebo (DRUG), Alfuzosin (DRUG).
Who is sponsoring clinical trial NCT00103402?
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00103402's enrollment target sits among peer trials
272 1214th of 2000 higher than 785 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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