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

Phase 2

Completed

• Conditions: Prostatitis
• Interventions: Drug: pentosan polysulfate sodium

• Registration Number: NCT00236990
• Lead Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Brief 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.

Study Timeline

• Study Completion: 2005-09
• Study First Submitted: 2005-10-07
• Study First Submitted QC: 2005-10-07
• Study First Posted: 2005-10-12
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-30
• Last Update Posted: 2011-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 283

Inclusion Criteria

• Diagnosis of chronic non-bacterial prostatitis/chronic pelvic pain syndrome
• symptoms of discomfort or pain in the perineal and/or pelvic region (lower abdomen) for at least three of the last six months for which there is no recognized cause
• symptoms persist despite treatment with antibiotics for non-bacterial prostatitis in the past six months.

Exclusion Criteria

• Clinically significant medical problems or other organ abnormalities
• psychiatric disorders
• urinary tract infection during the last three months
• history of bladder, urethral or prostate cancer
• Prostate Specific Antigen (PSA) greater than or equal to 4 ng/mL
• diagnosis or treatment for genital herpes or herpes flare within the last year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
001	pentosan polysulfate sodium	pentosan polysulfate sodium

Primary Outcome Measures

Name	Time	Method
The change in total NIH-CPSI score from baseline to Week 12

Secondary Outcome Measures

Name	Time	Method
Participant-reported Global Response Assessment at Week 12. Brief Male Sexual Function Index at Weeks 4, 8, and 12. Pelvic Pain Urgency and Frequency symptom scale at Weeks 4, 8, and 12.