Tanezumab in Osteoarthritis of the Hip or Knee (2)

NCT00863304

Last updated date
Study Location
Pfizer Investigational Site
Birmingham, Alabama, 35242, 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.
Osteoarthritis
Sex
Females and Males
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

- Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2

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


- pregnancy or intent to become pregnant


- BMI greater than 39


- other severe pain, significant cardiac, neurological or psychiatric disease

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Advanced Information
Descriptive Information
Brief Title  ICMJE Tanezumab in Osteoarthritis of the Hip or Knee (2)
Official Title  ICMJE A Phase 3 Randomized, Double Blind Placebo And Naproxen Controlled Multicenter Study of the Analgesic Efficacy And Study of Tanezumab in Patients With Osteoarthritis Of The Hip or Knee
Brief Summary Test the efficacy and safety of 2 doses of tanezumab compared with naproxen and placebo in patients with osteoarthritis
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Biological: tanezumab 10 mg
    tanezumab 10 mg one dose at weeks 0 and 8
  • Biological: tanezumab 5 mg
    tanezumab 5 mg one dose at weeks 0 and 8
  • Drug: naproxen
    naproxen 1000 mg daily for 16 weeks
  • Other: placebo
    placebo to match tanezumab and naproxen dosing
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: tanezumab 10 mg
  • Experimental: 2
    Intervention: Biological: tanezumab 5 mg
  • Active Comparator: 3
    Intervention: Drug: naproxen
  • Placebo Comparator: 4
    Intervention: Other: placebo
Publications *

*   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: June 28, 2010)
849
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2009)
800
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Osteoarthritis of the hip or knee according to Kellgren-Lawrence x-ray grade of 2

Exclusion Criteria:

  • pregnancy or intent to become pregnant
  • BMI greater than 39
  • other severe pain, significant cardiac, neurological or psychiatric disease
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00863304
Other Study ID Numbers  ICMJE A4091018
Has Data Monitoring Committee Yes
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 May 2011

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