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

McNeil-PPC

Status and phase: Completed; Phase 2

Conditions: Prostatitis

Treatments: Drug: pentosan polysulfate sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00236990

CR004687

Details and patient eligibility

About

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.

Full 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.

Enrollment: 283 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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283 participants in 1 patient group

001

Experimental group

Description:

pentosan polysulfate sodium

Treatment:

Drug: pentosan polysulfate sodium