Clinical Trial: An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 2, 16 Week, Multicenter, Randomized, Double-Blind Placebo-Controlled, Parallel Group Proof-Of-Concept Study Evaluating The Efficacy And Safety Of Tanezumab For The Treatment Of Pain Associated

Brief Summary: The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Change in daily average pain [ Time Frame: 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change in urinary diary variables of daytime and nightime frequency, urgency episodes and pain associated with urinary events. [ Time Frame: 16 weeks ]
  • Change in ejaculatory pain score and sleep disturbance score. [ Time Frame: 16 weeks ]
  • Safety endpoints, such as adverse events, laboratory tests, ECG, and residual urine measurement. [ Time Frame: 16 weeks ]
  • Change in daily worst pain [ Time Frame: 16 weeks ]
  • Change in Chronic Prostatitis Symptom Index (CPSI) [ Time Frame: 16 weeks ]
  • Global Response Assessment (GRA) [ Time Frame: 16 weeks ]
  • Patient Reported Treatment Index (PRTI) [ Time Frame: 16 weeks ]
  • Treatment failures [ Time Frame: 16 weeks ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: January 21, 2009
Date Started: March 2009
Date Completion:
Last Updated: March 14, 2011
Last Verified: March 2011