Skip to main content
OpenTrials
Completed

NCT Number: NCT00236990

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prostatitis Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pentosan polysulfate sodium

Drug

Primary outcomes

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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

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

Industry

Collaborators

  • Alza Corporation, DE, USA

Registry information

Official study title

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

Important dates

Study completion
2005
First posted
Oct 12, 2005
Registry last updated
Jul 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.