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

Last updated on December 2, 2019

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Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35209 United States
Contact
1-800-718-1021
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.
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- 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)

NCT00826514
Pfizer
Completed
An Efficacy And Safety Study Of Tanezumab For The Treatment Of Pain Associated With Chronic Abacterial Prostatitis

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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 SummaryThe purpose of this study is to determine whether tanezumab is effective in the treatment of pain associated with chronic prostatitis.
Detailed DescriptionNot 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 DateJanuary 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 CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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1-800-718-1021

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