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ABOUT THIS STUDY
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
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Osteoarthritis
Sex
Females and Males
Age
18-75 years
Inclusion Criteria
Show details
- osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2
Exclusion Criteria
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 | |||||||
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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 |
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Study Arms ICMJE |
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Publications * |
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* 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 | 614 | ||||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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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 |