An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis
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 WITH CHRONIC ABACTERIAL PROSTATITIS
3 other identifiers
interventional
62
5 countries
44
Brief Summary
The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2009
Shorter than P25 for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2009
CompletedFirst Posted
Study publicly available on registry
January 22, 2009
CompletedStudy Start
First participant enrolled
March 25, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2010
CompletedResults Posted
Study results publicly available
May 13, 2021
CompletedMay 13, 2021
April 1, 2021
10 months
January 21, 2009
April 20, 2021
April 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Average Daily Pain Score at Week 6
Participants assessed average chronic prostatitis pain in the last 24 hours on an 11-point numeric rating scale (NRS) ranging from 0 (no chronic prostatitis pain) to 10 (chronic prostatitis pain as bad as you can imagine). The average daily pain score was calculated as the mean of the scores over the last 7 days prior to each assessment time point. Higher score indicated severe pain.
Baseline, Week 6
Secondary Outcomes (21)
Change From Baseline in Average Daily Pain Score at Weeks 2, 4, 8, 10, and 16
Baseline, Weeks 2, 4, 8, 10, and 16
Change From Baseline in Worst Daily Pain Score at Weeks 2, 4, 6, 8, 10, and 16
Baseline, Weeks 2, 4, 6, 8, 10, and 16
Change From Baseline in National Institutes of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) Overall and Sub-scale Score at Weeks 2, 4, 6, 8, 10, and 16
Baseline, Weeks 2, 4, 6, 8, 10, and 16
Change From Baseline in Number of Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16
Baseline, Week 2, 4, 6, 8, 10, and 16
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Weeks 2, 4, 6, 8, 10, and 16
Baseline, Weeks 2, 4, 6, 8, 10, and 16
- +16 more secondary outcomes
Study Arms (2)
Tanezumab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Diagnosis of chronic prostatitis
- Male adults at least 18 years of age
- Moderate to severe chronic prostatitis, with an average pain score above a pre-defined level
- To use contraception.
You may not qualify if:
- History of symptoms for less than 3 of the last 6 months
- History of recurrent urinary tract infections, or genito-urinary cancer
- Use of finasteride or dutasteride within 6 months.
- History of hepatitis B, C or human immunodeficiency virus (HIV)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (44)
Alabama Research Center, LLC
Birmingham, Alabama, 35209, United States
The Kirklin Clinic
Birmingham, Alabama, 35233, United States
University of Alabama Birmingham
Birmingham, Alabama, 35294-3411, United States
Valley Urologic Associates
Goodyear, Arizona, 85395, United States
Dedicated Clinical Research
Litchfield Park, Arizona, 85340, United States
Clinical Innovations, Inc.
Costa Mesa, California, 92626, United States
Citrus Valley Medical Research Inc.
Glendora, California, 91741, United States
Atlantic Urological Medical Group Incorporated
Long Beach, California, 90806, United States
Orange Coast Urology
Newport Beach, California, 92663, United States
Los Angeles Infertility and Prostatitis Medical Group
Santa Monica, California, 90404, United States
Specialists in Urology
Bonita Springs, Florida, 34134, United States
Specialists in Urology
Naples, Florida, 34102, United States
Pinellas Urology, Inc.
St. Petersburg, Florida, 33710, United States
Regional Urology, LLC
Shreveport, Louisiana, 71106-8150, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Hudson Valley Urology, PC
Kingston, New York, 12401, United States
University Urology Associates
New York, New York, 10016, United States
Hudson Valley Urology, PC
Poughkeepsie, New York, 12601, United States
Tri-State Urologic Services PSC, Inc. dba The Urology Group
Cincinnati, Ohio, 45212, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Temple University of the Commonwealth System of Higher Education
Philadelphia, Pennsylvania, 19140, United States
University Urology
Knoxville, Tennessee, 37920, United States
Volunteer Research Group
Knoxville, Tennessee, 37920, United States
Prostate Cancer Centre / Urology Research
Calgary, Alberta, T2V 1P9, Canada
Office of Dr. Nazmuddin Merali
Victoria, British Columbia, V8R 6T9, Canada
Can-Med Clinical Research Inc.
Victoria, British Columbia, V8T 5G1, Canada
PJ Pommerville Inc.
Victoria, British Columbia, V8T 5G1, Canada
Dr. Steinhoff Clinical Research
Victoria, British Columbia, V8V 3N1, Canada
Manitoba Prostate Centre
Winnipeg, Manitoba, R3E 0V9, Canada
The Male/Female Health and Research Centre
Barrie, Ontario, L4M 7G1, Canada
Kingston General Hospital
Kingston, Ontario, K7L 2V7, Canada
Centre for Applied Urological Research
Kingston, Ontario, K7L 3J7, Canada
Urology Associates / Urologic Medical Research
Kitchener, Ontario, N2N 2B9, Canada
The Male Health Centre
Toronto, Ontario, M6A 3B5, Canada
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1, Canada
Hopital Edouard Herriot
Lyon, 69437, France
Centre Hospitalier Universitaire de NANTES (CHU)
Nantes, 44000, France
CHU de Nîmes - Hôpital CAREMEAU
Nîmes, 30029, France
Hopital TENON
Paris, 75020, France
Hopital Rothschild
Paris, 75571, France
Capio Citykliniken AB
Lund, 222 21, Sweden
Skaraborgs Sjukhus, FoU-centrum och urologkliniken
Skövde, 541 85, Sweden
Universitaetsspital Basel, Urologische Klinik
Basel, CH-4031, Switzerland
Klinik und Poliklinik fuer Urologie, Inselspital
Bern, CH-3010, Switzerland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2009
First Posted
January 22, 2009
Study Start
March 25, 2009
Primary Completion
January 11, 2010
Study Completion
March 17, 2010
Last Updated
May 13, 2021
Results First Posted
May 13, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.