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

This study has been completed.

Sponsors and Collaborators:	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. Alza Corporation, DE, USA
Information provided by:	McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
ClinicalTrials.gov Identifier:	NCT00236990

Purpose

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.

Condition	Intervention	Phase
Prostatitis	Drug: pentosan polysulfate sodium	Phase II

Drug Information available for: Elmiron Hoe-bay 946 Pentosan sulfuric polyester

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Trial of ELMIRON® (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Prostatitis.

Further study details as provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	400
Study Start Date:	August 2004
Estimated Study Completion Date:	September 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236990

Sponsors and Collaborators

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

Alza Corporation, DE, USA

Investigators

Study Director:

McNeil Consumer & Specialty Pharmaceuticals Clinical Trial

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

More Information

An Effectiveness and Safety Study of ELMIRON® (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Study ID Numbers:	CR004687
Study First Received:	October 7, 2005
Last Updated:	May 11, 2007
ClinicalTrials.gov Identifier:	NCT00236990
Health Authority:	United States: Food and Drug Administration

Keywords provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:

Elmiron
prostatitis
pentosan polysulfate sodium

Study placed in the following topic categories:

Prostatitis
Prostatic Diseases
Genital Diseases, Male
Pentosan Sulfuric Polyester
Inflammation

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009