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

June 30, 2011 updated by: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

A Double-Blind, Randomized, Placebo-Controlled Trial of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Prostatitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

283

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 001
pentosan polysulfate sodium
Drug: pentosan polysulfate sodium

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Alza Corporation, DE, USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Completion (Actual)

September 1, 2005

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (Estimate)

October 12, 2005

Study Record Updates

Last Update Posted (Estimate)

July 1, 2011

Last Update Submitted That Met QC Criteria

June 30, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004687

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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