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Sponsors and Collaborators: |
Pfizer PharmaNet |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00733902 |
Test the efficacy and safety of 3 doses in Osteoarthritis of the knee in patients.
Condition | Intervention | Phase |
---|---|---|
Arthritis Osteoarthritis |
Biological: tanezumab Biological: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3 Randomized, Double Blind, Placebo-Controlled Multicenter Study Of The Analgesic Efficacy And Safety Of Tanezumab In Patients With Osteoarthritis Of The Knee |
Estimated Enrollment: | 600 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Tanezumab 10 mg: Experimental |
Biological: tanezumab
IV tanezumab 10 mg at 1 dose every 8 weeks
|
Tanezumab 5 mg: Experimental |
Biological: tanezumab
IV tanezumab 5 mg at 1 dose every 8 weeks
|
Tanezumab 2.5 mg: Experimental |
Biological: tanezumab
IV tanezumab 2.5 mg at 1 dose every 8 weeks
|
Placebo: Placebo Comparator |
Biological: Placebo
IV placebo to match tanezumab at 1 dose every 8 weeks
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4091011 |
Study First Received: | August 11, 2008 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00733902 History of Changes |
Health Authority: | United States: Food and Drug Administration |
monoclonal antibody, RN624, PF-04383119, nerve growth factor, anti-nerve growth factor, OA, pain |
Antibodies, Monoclonal Osteoarthritis, Knee Antibodies Musculoskeletal Diseases Osteoarthritis Joint Diseases |
Arthritis Mitogens Pain Analgesics Rheumatic Diseases Immunoglobulins |
Osteoarthritis, Knee Musculoskeletal Diseases Osteoarthritis |
Joint Diseases Arthritis Rheumatic Diseases |