NCT02024529

A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee

A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of a Single Intra-articular Injection of Ampion in Adults With Pain Due to Osteoarthritis (OA) of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 538 (actual)
• Sponsor: Ampio Pharmaceuticals. Inc. · Industry
• Sex: All
• Age: 35 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
BIOLOGICAL	4 mL injection of Ampion	4 mL injection of Ampion
DRUG	4 mL Injection of Placebo	4 mL Injection of Placebo

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-05-01
• Completion: 2014-07-01
• First posted: 2013-12-31
• Last updated: 2022-08-09
• Results posted: 2022-08-09

Regulatory

• FDA-regulated drug study