Back to resultsAn Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland
Primary Purpose
Prostatitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
pentosan polysulfate sodium
Sponsored by
About this trial
This is an interventional treatment trial for Prostatitis focused on measuring prostatitis, Elmiron, pentosan polysulfate sodium
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
001
Arm Description
pentosan polysulfate sodium
Outcomes
Primary Outcome Measures
The change in total NIH-CPSI score from baseline to Week 12
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00236990
First Posted
October 7, 2005
Last Updated
June 30, 2011
Sponsor
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Collaborators
Alza Corporation, DE, USA
1. Study Identification
Unique Protocol Identification Number
NCT00236990
Brief Title
An Effectiveness and Safety Study of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland
Official Title
A Double-Blind, Randomized, Placebo-Controlled Trial of ELMIRON (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Prostatitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Collaborators
Alza Corporation, DE, USA
4. Oversight
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatitis
Keywords
prostatitis, Elmiron, pentosan polysulfate sodium
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
283 (Actual)
8. Arms, Groups, and Interventions
Arm Title
001
Arm Type
Experimental
Arm Description
pentosan polysulfate sodium
Intervention Type
Drug
Intervention Name(s)
pentosan polysulfate sodium
Primary Outcome Measure Information:
Title
The change in total NIH-CPSI score from baseline to Week 12
Secondary Outcome Measure Information:
Title
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.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial
Organizational Affiliation
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://download.veritasmedicine.com/PDF/CR004687_CSR.pdf
Description
An Effectiveness and Safety Study of ELMIRON� (Pentosan Polysulfate Sodium) for the Treatment of Chronic Non-Bacterial Inflammation of the Prostate Gland
Learn more about this trial
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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