NCT00236990

An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland

A Double-Blind, Randomized, Placebo-Controlled Trial of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Prostatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of ELMIRON® in the treatment of chronic non-bacterial inflammation of the prostate gland.

Detailed description

The objective of this randomized, double-blind, placebo-controlled study is to determine the effectiveness and safety of ELMIRON® 100 mg three times per day for 12 weeks, as compared with placebo, in patients with chronic non-bacterial inflammation of the prostate gland. Safety evaluations will be assessed throughout the study. The hypothesis of the study is that ELMIRON® will be more effective than placebo, as based on the change in the total National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score from baseline to the final visit (Week 12) and is generally well-tolerated. Patients will receive oral ELMIRON® 100 mg three times per day orally or matching placebo three times per day for 12 weeks.

Conditions

• Prostatitis

Interventions

Type	Name	Description
DRUG	pentosan polysulfate sodium

Timeline

• Completion: 2005-09-01
• First posted: 2005-10-12
• Last updated: 2011-07-01