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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00826514
Recruitment Status : Completed
First Posted : January 22, 2009
Last Update Posted : March 25, 2011
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Chronic Prostatitis With Chronic Pelvic Pain Syndrome Drug: Tanezumab Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : March 2010

Arm Intervention/treatment
Experimental: Tanezumab Drug: Tanezumab
Intravenous, 20 mg, single dose.

Placebo Comparator: Placebo Drug: Placebo
Intravenous placebo, single dose




Primary Outcome Measures :
  1. Change in daily average pain [ Time Frame: 6 weeks ]

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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00826514


Locations
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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, V8R 6T9
Pfizer Investigational Site
Victoria, British Columbia, Canada, V8T 5G1
Pfizer Investigational Site
Victoria, British Columbia, Canada, V8V 3N1
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 2V7
Pfizer Investigational Site
Kingston, Ontario, Canada, K7L 3J7
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 cedex 12, France, 75571
Pfizer Investigational Site
Paris, France, 75020
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
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00826514    
Other Study ID Numbers: A4091019
First Posted: January 22, 2009    Key Record Dates
Last Update Posted: March 25, 2011
Last Verified: March 2011
Keywords provided by Pfizer:
Chronic Prostatis
Additional relevant MeSH terms:
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Prostatitis
Pelvic Pain
Pain
Neurologic Manifestations
Prostatic Diseases
Tanezumab
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs