Status:
TERMINATED
Tanezumab and Nerve Function In Arthritis Patients
Lead Sponsor:
Pfizer
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
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 saf...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 18 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2010
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00863772
Start Date
May 18 2009
End Date
November 16 2010
Last Update
February 4 2021
Active Locations (97)
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1
NEA Baptist Clinic
Jonesboro, Arkansas, United States, 72401
2
JDP Medical Research, LLC
Aurora, Colorado, United States, 80014
3
Alpine Neurology
Centennial, Colorado, United States, 80112
4
Peak Anesthesia
Centennial, Colorado, United States, 80112