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

NCT00826514

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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)

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Chronic Prostatitis With Chronic Pelvic Pain SyndromeAn Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis
NCT00826514
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Birmingham, Alabama
  4. Goodyear, Arizona
  5. Litchfield Park, Arizona
  6. Costa Mesa, California
  7. Glendora, California
  8. Long Beach, California
  9. Newport Beach, California
  10. Santa Monica, California
  11. Bonita Springs, Florida
  12. Naples, Florida
  13. St. Petersburg, Florida
  14. Shreveport, Louisiana
  15. Omaha, Nebraska
  16. Kingston, New York
  17. New York, New York
  18. Poughkeepsie, New York
  19. Cincinnati, Ohio
  20. Cleveland, Ohio
  21. Philadelphia, Pennsylvania
  22. Knoxville, Tennessee
  23. Calgary, Alberta
  24. Victoria, British Columbia
  25. Victoria, British Columbia
  26. Victoria, British Columbia
  27. Winnipeg, Manitoba
  28. Barrie, Ontario
  29. Kingston, Ontario
  30. Kingston, Ontario
  31. Kitchener, Ontario
  32. Toronto, Ontario
  33. Montreal, Quebec
  34. Lyon Cedex 03,
  35. Nantes,
  36. Nimes Cedex 9,
  37. Paris cedex 12,
  38. Paris,
  39. Lund,
  40. Skovde,
  41. Basel,
  42. Bern,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis
Official Title  ICMJE 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
Brief Summary The purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Prostatitis With Chronic Pelvic Pain Syndrome
Intervention  ICMJE
  • Drug: Tanezumab
    Intravenous, 20 mg, single dose.
  • Drug: Placebo
    Intravenous placebo, single dose
Study Arms  ICMJE
  • Experimental: Tanezumab
    Intervention: Drug: Tanezumab
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 29, 2010)
62
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2009)
74
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   France,   Sweden,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00826514
Other Study ID Numbers  ICMJE A4091019
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP