Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis osteoarthritis of the knee
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 329
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy of two doses of 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 two Doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

The primary trial objective is to evaluate whether there is greater efficacy of 10 mL Ampion™ versus 10 mL placebo than 4 mL 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 include: the evaluation of the safety of an intra-articular injection of Ampion™ when applied to patients suffering from OA of the knee, evaluation of the efficacy of intra-articular injection of Ampion™ and placebo on stiffness and function when applied to patients suffering from OA of the knee and evaluation of responder status defined by the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) Criteria.

Arms:
arm 1: 4 mL Injection of Ampion arm 2: 4 mL Injection of Placebo arm 3: 10 mL Injection of Ampion arm 4: 10 mL Injection of Placebo

Interventions: intervention 1: 4 mL injection of Ampion intervention 2: 10 mL Injection of Ampion intervention 3: 4 mL Injection of Placebo intervention 4: 10 mL Injection of Placebo
Intervention descriptions: intervention 1: 4 mL Injection of Ampion intervention 2: 10 mL Injection of Ampion intervention 3: 4 mL Injection of Placebo intervention 4: 10 mL Injection of Placebo

Protocol document: