NCT02556710

A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

A Randomized, Placebo-Controlled, Double-Blind Study to Evaluated the Efficacy and Safety of an Intra-Articular Injection of AMPION™ in Adults With Pain Due to Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Ampio Pharmaceuticals. Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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™.

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: 2015-09-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2015-09-22
• Last updated: 2022-08-09
• Results posted: 2022-08-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study