Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab
- Must have participated in previous (specific) Phase 3 trials of Tanezumab in
osteoarthritis
- Willing to comply with scheduled visits and treatment plan Is medically fit to
participate in the trial in the judgement of the Investigator
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Extension Study Of Tanezumab In Osteoarthritis | ||||||
| Official Title ICMJE | A PHASE 3, MULTICENTER, RANDOMIZED, LONG TERM STUDY OF THE SAFETY OF TANEZUMAB IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP | ||||||
| Brief Summary | Safety extension study of Phase 3 Osteoarthritis trials with Tanezumab | ||||||
| Detailed Description | This study was terminated on 27 October 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: Double (Participant, Investigator) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Osteoarthritis | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Hochberg MC, Tive LA, Abramson SB, Vignon E, Verburg KM, West CR, Smith MD, Hungerford DS. When Is Osteonecrosis Not Osteonecrosis?: Adjudication of Reported Serious Adverse Joint Events in the Tanezumab Clinical Development Program. Arthritis Rheumatol. 2016 Feb;68(2):382-91. doi: 10.1002/art.39492. | ||||||
| * 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 | 2147 | ||||||
| Original Estimated Enrollment ICMJE | 2400 | ||||||
| Actual Study Completion Date ICMJE | June 23, 2011 | ||||||
| Actual Primary Completion Date | November 2, 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 99 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 | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00809783 | ||||||
| Other Study ID Numbers ICMJE | A4091016 P3 LONG TERM SAFETY EXTENSION ( 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
