Tanezumab In Osteoarthritis Of The Hip Or Knee

NCT00985621

Last updated date
Study Location
Achieve Clinical Research
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.
Osteoarthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- osteoarthritis of the knee or hip 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
Official Title  ICMJE A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO AND OXYCODONE CONTROLLED MULTI-CENTER STUDY OF THE EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP
Brief Summary The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis
Detailed Description This study was terminated on 13 Dec 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
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: oxycodone
    oxycodone CR, 10-40 mg q12h
  • Other: placebo
    placebo
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Biological: tanezumab 10 mg
  • Experimental: 2
    Intervention: Biological: tanezumab 5 mg
  • Active Comparator: 3
    Intervention: Drug: oxycodone
  • 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 Terminated
Actual Enrollment  ICMJE
 (submitted: May 23, 2019)
614
Original Estimated Enrollment  ICMJE
 (submitted: September 25, 2009)
800
Actual Study Completion Date  ICMJE February 4, 2011
Actual Primary Completion Date December 13, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • osteoarthritis of the knee or hip 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 to 75 Years   (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 Austria,   Denmark,   Germany,   Poland,   Spain,   Sweden,   United States
Removed Location Countries Romania
 
Administrative Information
NCT Number  ICMJE NCT00985621
Other Study ID Numbers  ICMJE A4091030
2009-013329-41 ( EudraCT Number )
OA OXY STUDY ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2019

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