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

NCT ID: NCT00236990

Last Updated: 2011-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 283 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2005-09-30

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.

Conditions

Prostatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

001

pentosan polysulfate sodium

Group Type: EXPERIMENTAL

pentosan polysulfate sodium

Intervention Type: DRUG

Interventions

pentosan polysulfate sodium

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Alza Corporation, DE, USA

INDUSTRY

Sponsor Role: collaborator

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

INDUSTRY

Sponsor Role: lead

Principal Investigators

McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

Role: STUDY_DIRECTOR

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

Related Links

http://download.veritasmedicine.com/PDF/CR004687_CSR.pdf

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

Other Identifiers

CR004687

Identifier Type: -

Identifier Source: org_study_id