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

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ClinicalTrials.gov Identifier: NCT00236990
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : July 1, 2011
Sponsor:
Collaborator:
Alza Corporation, DE, USA
Information provided by:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Prostatitis Drug: pentosan polysulfate sodium Phase 2

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 Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 001
pentosan polysulfate sodium
 Drug: pentosan polysulfate sodium


Outcome Measures
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Primary Outcome Measures :
  1. The change in total NIH-CPSI score from baseline to Week 12

Secondary Outcome Measures :
  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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Alza Corporation, DE, USA
Investigators
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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.
More Information
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Additional Information:

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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
Keywords provided by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.:
prostatitis
Elmiron
pentosan polysulfate sodium
Additional relevant MeSH terms:
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Prostatitis
Prostatic Diseases
Pentosan Sulfuric Polyester
Anticoagulants