NCT03988023

Study of Ampion for the Treatment of Pain and Function in Patients With Severe Osteoarthritis of the Knee.

A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults With Pain Due to Severe Osteoarthritis of the Knee.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,043 (actual)
• Sponsor: Ampio Pharmaceuticals. Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment of pain and function in patients with severe osteoarthritis of the knee.

Detailed description

This study is a randomized, double-blind, single dose design. The co-primary trial objectives are to evaluate the greater efficacy for pain improvement and function improvement of 4 mL Ampion versus saline intra-articular (IA) injection when applied to patients suffering from severe osteoarthritis of the knee (OAK). Efficacy will primarily be assessed with WOMAC A pain and WOMAC C function scores. Mean change in the WOMAC A weekly pain scores from Baseline to Week 12 will be compared between Ampion and saline control. Mean change in WOMAC C function score will be compared between Ampion and saline control. This will test whether Ampion is superior to saline in improving pain and function.

Conditions

• Severe Osteoarthritis of the Knee

Interventions

Type	Name	Description
BIOLOGICAL	Ampion	4 mL injection of Ampion
DRUG	Saline	Saline solution, 4 mL, single intra-articular injection

Timeline

• Start date: 2019-06-24
• Primary completion: 2021-07-13
• Completion: 2021-07-13
• First posted: 2019-06-17
• Last updated: 2022-10-05
• Results posted: 2022-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study