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Sponsored by: |
Pfizer |
---|---|
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00863772 |
Tanezumab reduces pain of osteoarthritis without affecting how nerve impulses are transmitted in sensory nerves.
Condition | Intervention | Phase |
---|---|---|
Osteoarthritis |
Biological: tanezumab Other: 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 Tanezumab On Peripheral Nerve Function In Patients With Osteoarthritis |
Estimated Enrollment: | 369 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | October 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Tanezumab 5 mg: Experimental |
Biological: tanezumab
5 mg dose Intravenously every 8 weeks for duration of study
|
Tanezumab 10 mg: Experimental |
Biological: tanezumab
10 mg dose Intravenously every 8 weeks for duration of study
|
Placebo: Placebo Comparator |
Other: Placebo
Placebo, Intravenously, every 8 weeks for duration of study
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A4091026 |
Study First Received: | March 17, 2009 |
Last Updated: | March 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00863772 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |
Musculoskeletal Diseases Osteoarthritis Joint Diseases Arthritis Rheumatic Diseases |