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.

Sponsor:

Collaborator:

Alza Corporation, DE, USA

Information provided by:

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

ClinicalTrials.gov Identifier:

NCT00236990

First received: October 7, 2005

Last updated: June 30, 2011

Last verified: June 2011

History of Changes

Purpose

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.

Condition	Intervention	Phase
Prostatitis	Drug: pentosan polysulfate sodium	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomized, Placebo-Controlled Trial of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Prostatitis

Resource links provided by NLM:

Drug Information available for: Pentosan polysulfate Pentosan polysulfate sodium

U.S. FDA Resources

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.


Enrollment:	283
Study Completion Date:	September 2005

Arms	Assigned Interventions
Experimental: 001 pentosan polysulfate sodium	Drug: pentosan polysulfate sodium

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 (Adult)
Sexes 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

More Information


ClinicalTrials.gov Identifier:	NCT00236990 History of Changes
Other Study ID Numbers:	CR004687
Study First Received:	October 7, 2005
Last Updated:	June 30, 2011

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


prostatitis Elmiron pentosan polysulfate sodium

Additional relevant MeSH terms:


Prostatitis Prostatic Diseases Genital Diseases, Male Pentosan Sulfuric Polyester Anticoagulants

ClinicalTrials.gov processed this record on September 21, 2017

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