A Randomized, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rofecoxib in the Treatment of Chronic Nonbacterial Prostatitis

No AccessJournal of UrologyCLINICAL UROLOGY: Original Articles1 Apr 2003A Randomized, Placebo Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rofecoxib in the Treatment of Chronic Nonbacterial Prostatitis J. CURTIS NICKEL, MICHEL PONTARI, TIMOTHY MOON, MARC GITTELMAN, GHOLAM MALEK, JEAN FARRINGTON, JAY PEARSON, DAVID KRUPA, MARK BACH, JENNIFER DRISKO, and THE ROFECOXIB PROSTATITIS INVESTIGATOR TEAM¶ J. CURTIS NICKELJ. CURTIS NICKEL , MICHEL PONTARIMICHEL PONTARI , TIMOTHY MOONTIMOTHY MOON , MARC GITTELMANMARC GITTELMAN , GHOLAM MALEKGHOLAM MALEK , JEAN FARRINGTONJEAN FARRINGTON , JAY PEARSONJAY PEARSON , DAVID KRUPADAVID KRUPA , MARK BACHMARK BACH , JENNIFER DRISKOJENNIFER DRISKO , and THE ROFECOXIB PROSTATITIS INVESTIGATOR TEAM¶ View All Author Informationhttps://doi.org/10.1097/01.ju.0000054983.45096.16AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We determine the effects of treatment with rofecoxib and placebo in patients with chronic prostatitis. Materials and Methods: Patients diagnosed with chronic nonbacterial prostatitis were randomized to 6 weeks of 25 or 50 mg., rofecoxib or placebo in a double-blind multicenter study with a 1-week run in of placebo. End points included the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (average pain score item 4 primary end point), and patient global assessment questions of pain, disease activity and response to therapy. Results: A total of 161 patients were randomized in the study. The NIH-CPSI total, domain and pain scores significantly decreased from baseline in all groups and, although the mean scores numerically favored the rofecoxib groups, the difference was not significantly different among groups. There was a trend for the percentage of patients with a 25% (or 6 point) improvement in total score being superior on rofecoxib versus placebo with the difference being significantly different (p <0.05) for the 50 mg. rofecoxib group. Patient global assessment of pain, response to therapy and disease activity also favored rofecoxib over placebo (p <0.05, p = 0.07, p = 0.06, respectively). Of the patients 79% on 50 mg. rofecoxib versus 59% on placebo reported no or mild pain, and 56% of patients on 50 mg. rofecoxib versus 27% on placebo experienced significant improvement in quality of life (p <0.005). Rofecoxib was generally well tolerated. Conclusions: To our knowledge this study is the first to evaluate rofecoxib versus placebo in patients with prostatitis and the first large multicenter treatment study to use the NIH-CPSI. Subjective assessment with patient global questions may be more sensitive to change than the NIH-CPSI and, therefore, may be a better tool to use in future therapeutic trials. Although 6 weeks of rofecoxib treatment appear to benefit many men diagnosed with chronic prostatitis/chronic pelvic pain syndrome further studies are needed. References 1 : How common is prostatitis? A national survey of physician visits. J Urol1998; 159: 1224. Google Scholar 2 : Epidemiology of prostatitis in Finnish men: a population-based cross-sectional study. 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Link, Google Scholar From the Department of Urology, Queen's University, Kingston General Hospital, Kingston, Ontario, Canada, the Department of Urology, Temple University School of Medicine, Philadelphia, Pennsylvania, University of Wisconsin Medical School and Jackson Foundation, Madison, Wisconsin, South Florida Medical Center, Aventura, Florida, and Merck Research Laboratories, Rahway, New Jersey© 2003 by American Urological Association, Inc.FiguresReferencesRelatedDetailsCited byWei X, Zhang G, Yuan H, Ding X, Li S, Zhang X and Hou J (2018) Detection and Quantitation of Soluble B7-H3 in Expressed Prostatic Secretions: A Novel Marker in Patients With Chronic ProstatitisJournal of Urology, VOL. 185, NO. 2, (532-537), Online publication date: 1-Feb-2011.Mishra V, Browne J and Emberton M (2018) Role of α-Blockers in Type III Prostatitis: A Systematic Review of the LiteratureJournal of Urology, VOL. 177, NO. 1, (25-30), Online publication date: 1-Jan-2007.Giubilei G, Mondaini N, Minervini A, Saieva C, Lapini A, Serni S, Bartoletti R and Carini M (2018) Physical Activity of Men With Chronic Prostatitis/Chronic Pelvic Pain Syndrome Not Satisfied With Conventional Treatments—Could it Represent a Valid Option? The Physical Activity and Male Pelvic Pain Trial: A Double-Blind, Randomized StudyJournal of Urology, VOL. 177, NO. 1, (159-165), Online publication date: 1-Jan-2007.NICKEL J, NARAYAN P, McKAY J and DOYLE C (2018) TREATMENT OF CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROME WITH TAMSULOSIN: A RANDOMIZED DOUBLE BLIND TRIALJournal of Urology, VOL. 171, NO. 4, (1594-1597), Online publication date: 1-Apr-2004.NICKEL J, DOWNEY J, ARDERN D, CLARK J and NICKEL K (2018) FAILURE OF A MONOTHERAPY STRATEGY FOR DIFFICULT CHRONIC PROSTATITIS/CHRONIC PELVIC PAIN SYNDROMEJournal of Urology, VOL. 172, NO. 2, (551-554), Online publication date: 1-Aug-2004. Volume 169Issue 4April 2003Page: 1401-1405 Advertisement Copyright & Permissions© 2003 by American Urological Association, Inc.Keywordscyclooxygenase inhibitorspelvic painprostatitisMetricsAuthor Information J. CURTIS NICKEL Financial interest and/or other relationship with Merck, Alza, Ortho-McNeil, Janssen-Ortho Canada, Bayer Canada, Sanofi Synthelabo Canada and Glaxo Smith Kline. More articles by this author MICHEL PONTARI Financial interest and/or other relationship with Merck and Pharmacia. More articles by this author TIMOTHY MOON Financial interest and/or other relationship with Boehringer-Ingleheim, Merck, Sanofi Synthelabo and Alza. More articles by this author MARC GITTELMAN Financial interest and/or other relationship with Glaxo, Zeneca, Abbott, Lilly, Sepracor, Pharmacia, Pfizer, Bayer, Vivus, Nexmed, Sanofi-Synthelabo, Praecis, Ortho-McNeil, Watson, Unimed, Myriad, Macrochem, Interneuron, Yamanouchi and Merck. More articles by this author GHOLAM MALEK More articles by this author JEAN FARRINGTON Financial interest and/or other relationship with Merck & Co., Inc. More articles by this author JAY PEARSON Financial interest and/or other relationship with Merck & Co., Inc. More articles by this author DAVID KRUPA Financial interest and/or other relationship with Merck & Co., Inc. More articles by this author MARK BACH Financial interest and/or other relationship with Merck & Co., Inc. More articles by this author JENNIFER DRISKO Financial interest and/or other relationship with Merck & Co., Inc. More articles by this author THE ROFECOXIB PROSTATITIS INVESTIGATOR TEAM¶ Participants: J. Coles, South Central Urology Specialists, Anchorage, Alaska; D. Owen Cook, Piedmont Research Associates, Winston-Salem, North Carolina; E. Dula, West Coast Clinical, Van Nuys, California; D. J. Ellis, ** Bryn Mawr Urology Associates, Bryn Mawr, Pennsylvania; M. Fallick, Center for Urologic Care, Voorhees, New Jersey; R. A. Feldman, CT Clinical Research Center (CCRC), Waterbury, Connecticut; P. Hudson, VA Medical Center, Bay Pines, Florida; R. Israeli, ** Nalitt Cancer Center, Staten Island, New York; K. Jacoby, Seattle, Washington; Steven A. Kaplan, ** College of Physicians and Surgeons, New York, New York; Joel Kaufman, Urology Research Options, Aurora, Colorado; James G. McMurray, Medical Affiliated Research Center, Inc., Huntsville, Alabama; Myron Murdock, 206 Research Associates, Greenbelt, Maryland; Durwood E. Neal, Jr., University of Missouri, Columbia, Missouri; Jeannette M. Potts, Cleveland Clinic Foundation, Cleveland, Ohio; Harvey Resnick, R/D Clinical Research, Lake Jackson, Texas; Claus G. Roehrborn, ** Southwestern Medical Center at Dallas, Dallas, Texas; Anthony Schaeffer, Northwestern University Medical School, Chicago, Illinois; Kevin Tomera, Alaska Clinical Research Center, Anchorage, Alaska; and Norman Zinner, Western Clinical Research, Inc., Torrance, California. More articles by this author Expand All Advertisement PDF downloadLoading ...