Status:
COMPLETED
Tanezumab in Osteoarthritis Of The Hip
Lead Sponsor:
Pfizer
Conditions:
Arthritis
Osteoarthritis
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test the efficacy and safety of 3 doses of tanezumab in osteoarthritis of the hip in patients
Eligibility Criteria
Inclusion
- Osteoarthritis of the hip according to ACR criteria with 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 Hip injections, arthroplasty or replacement 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
- 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 :
November 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2010
Estimated Enrollment :
627 Patients enrolled
Trial Details
Trial ID
NCT00744471
Start Date
November 17 2008
End Date
August 13 2010
Last Update
February 26 2021
Active Locations (99)
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1
Horizon Research Group
Mobile, Alabama, United States, 36608
2
Arizona Arthritis & Rheumatology Associates, PC
Paradise Valley, Arizona, United States, 85253
3
Pivotal Research Center
Peoria, Arizona, United States, 85381
4
Arizona Research Center, Inc.
Phoenix, Arizona, United States, 85023