Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis Osteoarthritis of the Knee
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 480
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy and safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the knee

Detailed description:
A Randomized, Placebo-Controlled, Double-Blind Study To Evaluate The Efficacy And Safety Of An Intra-Articular Injection Of AMPION™ In Adults With Pain Due to Osteoarthritis Of The Knee

The primary trial objective is to evaluate the efficacy of 4 mL of AMPION™ versus 4 mL placebo intra-articular (IA) injection in improving knee pain, when applied to patients suffering from OA of the knee.

The secondary trial objective is evaluation of the safety of an intra-articular injection of AMPION™.

Arms:
arm 1: 4 mL injection of Ampion arm 2: 4 mL Injection of Placebo

Interventions: intervention 1: 4 mL injection of AMPION™ intervention 2: 4 mL injection of Placebo
Intervention descriptions: intervention 1: 4 mL Injection of Ampion intervention 2: 4 mL Injection of Placebo

Protocol document: