Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis osteoarthritis of the knee
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 538
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy 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 study objective was to evaluate the efficacy of 4 mL Ampion versus 4 mL saline intra-articular (IA) injection in treating knee pain when administered to subjects suffering from osteoarthritis (OA) of the knee (OAK).

The secondary study objectives included evaluation of the safety of an IA injection of Ampion vs saline, efficacy of IA injection of Ampion vs saline in improving knee function.

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: