An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00236990 |
Recruitment Status :
Completed
First Posted : October 12, 2005
Last Update Posted : July 1, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Prostatitis | Drug: pentosan polysulfate sodium | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 283 participants |
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 |
Actual Study Completion Date : | September 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: 001
pentosan polysulfate sodium
|
Drug: pentosan polysulfate sodium |
- The change in total NIH-CPSI score from baseline to Week 12
- 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.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00236990
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. |
ClinicalTrials.gov Identifier: | NCT00236990 |
Other Study ID Numbers: |
CR004687 |
First Posted: | October 12, 2005 Key Record Dates |
Last Update Posted: | July 1, 2011 |
Last Verified: | June 2011 |
prostatitis Elmiron pentosan polysulfate sodium |
Prostatitis Prostatic Diseases Pentosan Sulfuric Polyester Anticoagulants |