Conditions: Osteoarthritis
Keywords: monoclonal antibody RN624 PF-04383119 nerve growth factor OA pain arthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 614
Healthy volunteers: no

Brief summary:
The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared to oxycodone CR and placebo in patients with osteoarthritis

Detailed description:
This study was terminated on 13 Dec 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: tanezumab 10 mg intervention 2: tanezumab 5 mg intervention 3: oxycodone intervention 4: placebo
Intervention descriptions: intervention 1: tanezumab 10 mg one dose at weeks 0 and 8 intervention 2: tanezumab 5 mg one dose at weeks 0 and 8 intervention 3: oxycodone CR, 10-40 mg q12h intervention 4: placebo

Protocol document: