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