Status:
COMPLETED
Tanezumab in Osteoarthritis of the Knee
Lead Sponsor:
Pfizer
Conditions:
Arthritis
Osteoarthritis
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
Eligibility Criteria
Inclusion
- Osteoarthritis of the knee according to ACR criteria with a Kellgren-Lawrence x-ray grade of 2.
- Unwilling or unable to take non-opiate pain medications, for whom non-opiate pain medications have not provided adequate pain relief or are candidates for knee injections arthroplasty or replace surgery.
- Pain level and function levels as required by the protocol at Screening and Baseline.
- Willing to discontinue pain medications (acetaminophen will be permitted up to a certain level) before and during the study.
- Must agree to the contraceptive requirements of the protocol if applicable.
- Must agree to the treatment plan, scheduled visits, and procedures of the protocol.
Exclusion
- Pregnancy or intent to become pregnant during the study
- BMI greater than 39
- other severe pain, significant cardiac, neurological or psychological conditions, or above the protocol limits for laboratory and blood pressure results
Key Trial Info
Start Date :
September 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2010
Estimated Enrollment :
697 Patients enrolled
Trial Details
Trial ID
NCT00733902
Start Date
September 15 2008
End Date
January 14 2010
Last Update
March 22 2021
Active Locations (82)
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1
Arizona Research Center, Inc.
Phoenix, Arizona, United States, 85023
2
Clinical Research Center of Connecticut
Danbury, Connecticut, United States, 06810
3
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
4
Javed Rheumatology Associates, Inc.
Newark, Delaware, United States, 19713