Clinical Trials Resource Center

Chronic Pelvic Pain

May 23, 2011

Watson Pharmaceuticals released results from a phase II trial of Rapaflo for non-bacterial chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). This double-blind, 12-week, placebo-controlled trial enrolled 151 subjects with moderate to severe CP/CPPS who had not received treatment. The subjects were randomized to Rapaflo 4 mg or 8 mg per day, or placebo for 12 weeks. The primary measure of efficacy was improvement in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) scale after 12 weeks. Rapaflo 4 mg significantly decreased the total score versus placebo on quality of life measures (P≡0.0224) and urinary symptoms (P≡.0102). In addition, Rapaflo 4 mg showed significantly better results relative to placebo on the physical component of the 12-Item Short Form Health Survey (P≡.049) and in a global response assessment, 56% of subjects versus 29% of subjects receiving placebo reported moderate or marked improvement (P≡ 0.0069). An increase in dose to 8 mg resulted in no incremental increased effect. No unexpected adverse events were reported.

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