Conditions: Osteoarthritis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 121
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of a single intra-articular (IA) injection of botulinum toxin Type A compared with placebo as treatment for osteoarthritis (OA) knee pain.

Detailed description:

Arms:
arm 1: A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1. arm 2: A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.

Interventions: intervention 1: botulinum toxin Type A intervention 2: Normal Saline
Intervention descriptions: intervention 1: A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1. intervention 2: A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.

Protocol document: