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

Prostatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236990
• Other study ID #: CR004687
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2005
• Last updated: June 30, 2011
• Est. completion date: September 2005

Study information

• Verified date: June 2011
• Source: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 283
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatitis

Intervention

Drug:
• pentosan polysulfate sodium

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.	Alza Corporation, DE, USA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in total NIH-CPSI score from baseline to Week 12
Secondary	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.