An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00826514
First received: January 21, 2009
Last updated: March 14, 2011
Last verified: March 2011
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Purpose
The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Prostatitis With Chronic Pelvic Pain Syndrome |
Drug: Tanezumab Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 With Chronic Abacterial Prostatitis |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change in daily average pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in urinary diary variables of daytime and nightime frequency, urgency episodes and pain associated with urinary events. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in ejaculatory pain score and sleep disturbance score. [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Safety endpoints, such as adverse events, laboratory tests, ECG, and residual urine measurement. [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]
- Change in daily worst pain [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Change in Chronic Prostatitis Symptom Index (CPSI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Global Response Assessment (GRA) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Patient Reported Treatment Index (PRTI) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
- Treatment failures [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 62 |
| Study Start Date: | March 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tanezumab |
Drug: Tanezumab
Intravenous, 20 mg, single dose.
|
| Placebo Comparator: Placebo |
Drug: Placebo
Intravenous placebo, single dose
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826514
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| United States, Alabama | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35209 | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35233 | |
| Pfizer Investigational Site | |
| Birmingham, Alabama, United States, 35294-3411 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Goodyear, Arizona, United States, 85395 | |
| Pfizer Investigational Site | |
| Litchfield Park, Arizona, United States, 85340 | |
| United States, California | |
| Pfizer Investigational Site | |
| Costa Mesa, California, United States, 92626 | |
| Pfizer Investigational Site | |
| Glendora, California, United States, 91741 | |
| Pfizer Investigational Site | |
| Long Beach, California, United States, 90806 | |
| Pfizer Investigational Site | |
| Newport Beach, California, United States, 92663 | |
| Pfizer Investigational Site | |
| Santa Monica, California, United States, 90404 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Bonita Springs, Florida, United States, 34134 | |
| Pfizer Investigational Site | |
| Naples, Florida, United States, 34102 | |
| Pfizer Investigational Site | |
| St. Petersburg, Florida, United States, 33710 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Shreveport, Louisiana, United States, 71106-8150 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Kingston, New York, United States, 12401 | |
| Pfizer Investigational Site | |
| New York, New York, United States, 10016 | |
| Pfizer Investigational Site | |
| Poughkeepsie, New York, United States, 12601 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cincinnati, Ohio, United States, 45212 | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Knoxville, Tennessee, United States, 37920 | |
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2V 1P9 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Victoria, British Columbia, Canada, V8V 3N1 | |
| Pfizer Investigational Site | |
| Victoria, British Columbia, Canada, V8R 6T9 | |
| Pfizer Investigational Site | |
| Victoria, British Columbia, Canada, V8T 5G1 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3E 0V9 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Barrie, Ontario, Canada, L4M 7G1 | |
| Pfizer Investigational Site | |
| Kingston, Ontario, Canada, K7L 3J7 | |
| Pfizer Investigational Site | |
| Kingston, Ontario, Canada, K7L 2V7 | |
| Pfizer Investigational Site | |
| Kitchener, Ontario, Canada, N2N 2B9 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M6A 3B5 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| France | |
| Pfizer Investigational Site | |
| Lyon Cedex 03, France, 69437 | |
| Pfizer Investigational Site | |
| Nantes, France, 44000 | |
| Pfizer Investigational Site | |
| Nimes Cedex 9, France, 30029 | |
| Pfizer Investigational Site | |
| Paris, France, 75020 | |
| Pfizer Investigational Site | |
| Paris cedex 12, France, 75571 | |
| Sweden | |
| Pfizer Investigational Site | |
| Lund, Sweden, 222 21 | |
| Pfizer Investigational Site | |
| Skovde, Sweden, 541 85 | |
| Switzerland | |
| Pfizer Investigational Site | |
| Basel, Switzerland, CH-4031 | |
| Pfizer Investigational Site | |
| Bern, Switzerland, CH-3010 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00826514 History of Changes |
| Other Study ID Numbers: | A4091019 |
| Study First Received: | January 21, 2009 |
| Last Updated: | March 14, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Chronic Prostatis |
Additional relevant MeSH terms:
|
Pelvic Pain Prostatitis Chronic Disease Pain Signs and Symptoms |
Prostatic Diseases Genital Diseases, Male Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013