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

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Collaborator: Alza Corporation, DE, USA
• Treatments: Pentosan Sulfuric Polyester

Criteria

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.