ABOUT THIS STUDY
FOR MORE INFORMATION
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
- BMI less or equal to 39 kg/m2
- Osteoarthritis (arthritis) of the knee or hip with pain score that qualifies
- Willing to comply with study visit schedule and study requirements, including, for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control, one of which is a barrier method.
- Patients must consent in writing to participate in the study.
- Untreated, uncontrolled diseases,
- Unwilling or unable to discontinue the use of prohibited medications, including other
pain medications, during the screening period and during the study,
- Significant cardiac disease within the past 6 months
- Significant neurological disease (e.g. peripheral neuropathy, multiple sclerosis,
stroke) or signs of neuropathy at screening
- Known bleeding disorder or anticoagulation therapy
- Planned surgery during the study period
- History of alcoholism or drug abuse in the past 2 years
- Unable to use acetaminophen
- Use of a biologic (including live vaccines, with the exception of Flumist) within the
past 3 months
- Allergic reaction to a biologic or an antibody in the past
- Disqualifying laboratory values, including Hepatitis B or C, HIV or drug test
- Cancer in the past 5 years. Basal cell or squamous cell carcinoma are okay.
- Medical condition that may interfere with study endpoints or safety of the subject as
determined by the investigator.
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Descriptive Information | ||||
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Brief Title ICMJE | Tanezumab and Nerve Function In Arthritis Patients | |||
Official Title ICMJE | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Multicenter Study Of Tanezumab On Peripheral Nerve Function In Patients With Osteoarthritis | |||
Brief Summary | Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves. | |||
Detailed Description | This study was terminated on 16 Nov 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 * |
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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 | 220 | |||
Original Estimated Enrollment ICMJE | 369 | |||
Actual Study Completion Date ICMJE | November 2010 | |||
Actual Primary Completion Date | November 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 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 | Not Provided | |||
Removed Location Countries | Canada, United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00863772 | |||
Other Study ID Numbers ICMJE | A4091026 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | August 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |