Conditions: Osteoarthritis, Knee
Keywords: monoclonal antibody
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 83
Healthy volunteers: no

Brief summary:
To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee (Part I). To evaluate the preliminary analgesic efficacy of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee in comparison with placebo (Part I and Part II).

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None

Interventions: intervention 1: PF-04383119 (tanezumab) intervention 2: PF-04383119 (tanezumab) intervention 3: PF-04383119 (tanezumab) intervention 4: PF-04383119 (tanezumab) intervention 5: PF-04383119 (tanezumab) intervention 6: PF-04383119 (tanezumab)
Intervention descriptions: intervention 1: single dose of 10 mcg/kg IV intervention 2: single dose of 100 mcg/kg IV intervention 3: single dose of 200 mcg/kg IV intervention 4: single dose of 25 mcg/kg IV intervention 5: single dose of 50 mcg/kg IV intervention 6: single dose of Placebo IV

Protocol document: