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

McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.283 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

283

Conditions

Prostatitis

Interventions

pentosan polysulfate sodiumDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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