A Phase 2 interventional study of pentosan polysulfate sodium in Prostatitis, sponsored by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.. Completed. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-07-01.
Sponsored by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. · Phase 2, Interventional, and Treatment
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.
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.
83 studies on the registry are indexed under Prostatitis; 9 are open to participants now.
This study's enrollment of 283 is above the median of 60 across 66 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
No study locations are listed for this record.
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.