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
- osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2
- pregnancy or intent to become pregnant
- BMI greater than 39
- other severe pain, significant cardiac, neurological or psychiatric disease
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | |||||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
