Status:
COMPLETED
An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland
Lead Sponsor:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Collaborating Sponsors:
Alza Corporation, DE, USA
Conditions:
Prostatitis
Eligibility:
MALE
18-65 years
Phase:
PHASE2
Brief 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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
283 Patients enrolled
Trial Details
Trial ID
NCT00236990
End Date
September 1 2005
Last Update
July 1 2011
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