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Third International Chronic Prostatitis Network

Rofecoxib in the treatment of chronic nonbacterial prostatitis:

A Phase II randomized placebo controlled study
J. Nickel,1 M. Gittleman,2 G. Malek,3 T. Moon,4 M. Murdock,5 K. Tomera,6 M. Pontari,7 N. Zinner,8 R. Feldman,9 D. Cook,10 J. Coles,11 M. Fallick,12 C. Roehrborn,13 J. Kaufman,14 R. Israeli,15 S. Kaplan,16 J. McMurray,17 H. Resnick,18 A. Schaeffer,19 D. Ellis,20 K. Jacoby,21 D. Neal,22 E. Dula,23 J. Potts,24 P. Hudson,25 J. Drisko,26 D. Krupa,26 J. Pearson,26 J. Farrington,26 M. Bach
1Queens University, Kingston, Canada 2South Florida Medical Center, Aventura, FL 3Jackson Foundation, Madison, WI 4University of Wisconsin Medical School, Madison, WI 5206 Research Associates, Greenbelt, MD 6Alaska Clinical Research Center, Anchorage, AK 7Temple University School of Medicine, Philadelphia, PA 8Western Clinical Research, Inc., Torrance, CA 9CT Clinical Research Center, Waterbury, CT 10Piedmont Research Associates, Winston-Salem, NC 11South Central Urology Specialists, Anchorage, AK 12Center for Urologic Care, Voorhees, NJ 13Southwestern Medical Center at Dallas, Dallas, TX 14Urology Research Options, Aurora, CO 15Nalitt Cancer Center, Staten Island, NY 16Given Foundation, New York, NY 17Medical Affiliated Research Center, Inc., Huntsville, AL 18R/D Clinical Research, Lake Jackson, TX 19Northwestern University Medical School, Chicago, IL 20Bryn Mawr Urology Associates, Bryn Mawr, PA 21Integrity Medical Research LLC, Seattle, WA 22Southern Illinois University, Springfield, IL 23West Coast Clinical, Van Nuys, CA 24Cleveland Clinic Foundation, Cleveland, OH 25VA Medical Center, Bay Pines, FL 26Merck Research Laboratories, Rahway, NJ
Purpose
To determine the effects of treatment with rofecoxib for six weeks compared to placebo on pain, voiding symptoms and quality of life associated with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS category III) as measured by the NIH chronic prosta-titis symptom index (NIH-CPI) and patient global assessment questions. None of these tools had been previously used in multicenter placebo-controlled trials; therefore, an additional goal was to assess the responsiveness of these instruments in this setting.
Study Design
The study was a randomized, double-blind, placebo controlled parallel group, multicenter study. Following a one week placebo run in, patients were randomized to 6 weeks treatment with placebo, rofecoxib 25 mg/day or rofecoxib 50 mg/day. Male patients older than 18 years of age who met the NIH definition of Category III CP/CPPS, with a minimum NIH-CPSI aver-age pain score (question 4) of greater than or equal to 4 were eligible for enrollment. The evaluation of symptoms was determined by the following patient questionnaires: NIH-CPSI, patient global assessment questions, symptom frequency questionnaire (SFQ), symptom severity index (SSI), and the short form health survey (SF-12). Safety measurements included clinical evaluation and laboratory safety tests.
Results
A total of 161 eligible patients were randomized to placebo (n=59), 25 mg/day of rofecoxib (n=53) or 50 mg/day of rofecoxib (n=49). The baseline patient characteristics (age, height, body weight and race) were similar between treatment groups. Twenty-seven percent of the patients were classified as Category IIIA CPPS while 73% were classified as Category IIIB CPPS. Preliminary data analysis demonstrated improvement on rofecoxib, especially in category IIIB patients. Subjective global assessment questions appeared to provide a more sensitive indication of response to therapy than the change in NIH-CPSI score (either total score or specific domain score). Rofecoxib was generally well tolerated.
Conclusion
This phase II pilot study suggests that patients with Category IIIB CPPS may benefit from treatment with rofecoxib; however, fur ther study is needed. This study was funded by Merck Research Laboratories

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