NCT03349645

Open Label Extension to Assess the Safety of Long-Term Treatment With Ampion for Severe Osteoarthritis (OA) of the Knee

An Open Label Extension Study to Assess the Safety of Long-Term Treatment With a 4 mL 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: 94 (actual)
• Sponsor: Ampio Pharmaceuticals. Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This Open Label Extension (OLE) study will assess the safety of long-term treatment with a 4 mL intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee

Detailed description

An Open Label Extension (OLE) study will assess the safety of long-term treatment with a 4 mL intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee. The primary trial objective was to evaluate the safety of a 4-mL intra-articular (IA) injection of Ampion with repeat dosing every 12 weeks for 52 weeks with five total injections of Ampion.

Conditions

• Severe Osteoarthritis of the Knee

Interventions

Type	Name	Description
BIOLOGICAL	4 mL injection of AMPION™	4 mL injection of AMPION™

Timeline

• Start date: 2017-12-08
• Primary completion: 2018-10-04
• Completion: 2018-10-04
• First posted: 2017-11-21
• Last updated: 2022-10-03
• Results posted: 2022-10-03

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study