Status:
TERMINATED
A Long Term Study of the Safety of Tanezumab When Administered By Subcutaneous Injections
Lead Sponsor:
Pfizer
Conditions:
Osteoarthritis, Knee
Osteoarthritis, Hip
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the stud...
Detailed Description
Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosi...
Eligibility Criteria
Inclusion
- Osteoarthritis of the knee or hip based on American College of Rheumatology criteria with a radiographic (X ray) confirmation (a Kellgren Lawrence x-ray grade of ≥2);
Exclusion
- Body mass index (BMI) of \>39 kg/m2;
- Pregnancy or intent to become pregnant
- Planned surgical procedure during the duration of the study
- History of clinically significant cardiovascular, central nervous system or psychiatric disease
- Previous exposure to exogenous NGF or to an anti NGF antibody;
- Use of biologics other than study medication, Live or live-attenuated intranasal vaccines (eg, Flumist), are allowable exceptions
Key Trial Info
Start Date :
November 17 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
679 Patients enrolled
Trial Details
Trial ID
NCT00994890
Start Date
November 17 2009
End Date
March 1 2011
Last Update
May 13 2021
Active Locations (100)
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1
Mobile Diagnostic Center
Mobile, Alabama, United States, 36608
2
Seton Medical Management, Inc.
Mobile, Alabama, United States, 36608
3
Phoenix Rheumatology Specialists, Ltd.
Phoenix, Arizona, United States, 85006
4
Radiant Research, Inc
Scottsdale, Arizona, United States, 85251