A 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, J. Coles, D. Owen Cook, E. Dula, D. J. Ellis, M. Fallick, R. A. Feldman, P. Hudson, R. Israeli, K. Jacoby, Steven A. KaplanJoel Kaufman, James G. McMurray, Myron Murdock, Durwood Earnest Neal, Jeannette M. Potts, Harvey Resnick, Claus G. Roehrborn, Anthony Schaeffer, Kevin Tomera, Norman Zinner

Research output: Contribution to journalArticle

110 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)1401-1405
Number of pages5
JournalJournal of Urology
Volume169
Issue number4
DOIs
StatePublished - Apr 1 2003

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Prostatitis
Multicenter Studies
Placebos
Safety
National Institutes of Health (U.S.)
Therapeutics
Pain Measurement
Pain
rofecoxib
Double-Blind Method
Quality of Life

Keywords

  • Cyclooxygenase inhibitors
  • Pelvic pain
  • Prostatitis

ASJC Scopus subject areas

  • Urology

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A randomized, placebo controlled, multicenter study to evaluate the safety and efficacy of rofecoxib in the treatment of chronic nonbacterial prostatitis. / Nickel, J. Curtis; Pontari, Michel; Moon, Timothy; Gittelman, Marc; Malek, Gholam; Farrington, Jean; Pearson, Jay; Krupa, David; Bach, Mark; Drisko, Jennifer; Coles, J.; Cook, D. Owen; Dula, E.; Ellis, D. J.; Fallick, M.; Feldman, R. A.; Hudson, P.; Israeli, R.; Jacoby, K.; Kaplan, Steven A.; Kaufman, Joel; McMurray, James G.; Murdock, Myron; Neal, Durwood Earnest; Potts, Jeannette M.; Resnick, Harvey; Roehrborn, Claus G.; Schaeffer, Anthony; Tomera, Kevin; Zinner, Norman.

In: Journal of Urology, Vol. 169, No. 4, 01.04.2003, p. 1401-1405.

Research output: Contribution to journalArticle

Nickel, JC, Pontari, M, Moon, T, Gittelman, M, Malek, G, Farrington, J, Pearson, J, Krupa, D, Bach, M, Drisko, J, Coles, J, Cook, DO, Dula, E, Ellis, DJ, Fallick, M, Feldman, RA, Hudson, P, Israeli, R, Jacoby, K, Kaplan, SA, Kaufman, J, McMurray, JG, Murdock, M, Neal, DE, Potts, JM, Resnick, H, Roehrborn, CG, Schaeffer, A, Tomera, K & Zinner, N 2003, 'A randomized, placebo controlled, multicenter study to evaluate the safety and efficacy of rofecoxib in the treatment of chronic nonbacterial prostatitis', Journal of Urology, vol. 169, no. 4, pp. 1401-1405. https://doi.org/10.1097/01.ju.0000054983.45096.16
Nickel, J. Curtis ; Pontari, Michel ; Moon, Timothy ; Gittelman, Marc ; Malek, Gholam ; Farrington, Jean ; Pearson, Jay ; Krupa, David ; Bach, Mark ; Drisko, Jennifer ; Coles, J. ; Cook, D. Owen ; Dula, E. ; Ellis, D. J. ; Fallick, M. ; Feldman, R. A. ; Hudson, P. ; Israeli, R. ; Jacoby, K. ; Kaplan, Steven A. ; Kaufman, Joel ; McMurray, James G. ; Murdock, Myron ; Neal, Durwood Earnest ; Potts, Jeannette M. ; Resnick, Harvey ; Roehrborn, Claus G. ; Schaeffer, Anthony ; Tomera, Kevin ; Zinner, Norman. / A randomized, placebo controlled, multicenter study to evaluate the safety and efficacy of rofecoxib in the treatment of chronic nonbacterial prostatitis. In: Journal of Urology. 2003 ; Vol. 169, No. 4. pp. 1401-1405.
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T1 - A randomized, placebo controlled, multicenter study to evaluate the safety and efficacy of rofecoxib in the treatment of chronic nonbacterial prostatitis

AU - Nickel, J. Curtis

AU - Pontari, Michel

AU - Moon, Timothy

AU - Gittelman, Marc

AU - Malek, Gholam

AU - Farrington, Jean

AU - Pearson, Jay

AU - Krupa, David

AU - Bach, Mark

AU - Drisko, Jennifer

AU - Coles, J.

AU - Cook, D. Owen

AU - Dula, E.

AU - Ellis, D. J.

AU - Fallick, M.

AU - Feldman, R. A.

AU - Hudson, P.

AU - Israeli, R.

AU - Jacoby, K.

AU - Kaplan, Steven A.

AU - Kaufman, Joel

AU - McMurray, James G.

AU - Murdock, Myron

AU - Neal, Durwood Earnest

AU - Potts, Jeannette M.

AU - Resnick, Harvey

AU - Roehrborn, Claus G.

AU - Schaeffer, Anthony

AU - Tomera, Kevin

AU - Zinner, Norman

PY - 2003/4/1

Y1 - 2003/4/1

N2 - 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.

AB - 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.

KW - Cyclooxygenase inhibitors

KW - Pelvic pain

KW - Prostatitis

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