Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis osteoarthritis of the knee
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 342
Healthy volunteers: no

Brief summary:
This study will evaluate the efficacy of three intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Detailed description:
A randomized, placebo-controlled, double-blinded study to evaluate the efficacy and safety of repeated intra-articular injections of Ampion™ in adult subjects with advanced osteoarthritis of the knee.

The primary study objective was to evaluate the efficacy and safety from Baseline to Week 20 of 3 Ampion™ 4 mL intra-articular (IA) injections vs saline administered 2 weeks apart in improving knee pain in subjects suffering from osteoarthritis (OA) of the knee (OAK).

The secondary study objective was to analyze the effect of Ampion 4 mL vs saline on a change in Patient's Global Assessment (PGA) and knee function from Baseline to Week 20.

Arms:
arm 1: 4 mL intra-articular injection of Ampion arm 2: 4 mL placebo intra-articular injection

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: None

Protocol document: