Conditions: Osteoarthritis, Knee Osteoarthritis, Hip
Keywords: Double-blind safety
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 679
Healthy volunteers: no

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 study treatment period.

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 dosing and enrollment of patients on 23 June 2010 for potential safety issues.

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

Interventions: intervention 1: Tanezumab 2.5 mg intervention 2: Tanezumab 5 mg intervention 3: Tanezumab 10 mg
Intervention descriptions: intervention 1: Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year intervention 2: Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year intervention 3: Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year

Protocol document: