NCT03182686

AP-003-C Study to Confirm the Efficacy of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

A Phase 3 Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Ampio Pharmaceuticals. Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3 randomized study to confirm the efficacy of an intra-articular injection of Ampion™ in adults with pain due to severe osteoarthritis of the knee.

Detailed description

A Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee There will be a 7-day screening period for each subject followed by a 12-week participation period. The primary trial objective is to evaluate the clinical efficacy of Ampion using the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) (using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) 3.1 Index and Patient's Global Assessment as assessments). The secondary trial objectives are to evaluate the safety of a single intra-articular injection (4 mL) of Ampion.

Conditions

• Osteoarthritis, Knee
• Knee Osteoarthritis
• Knee Arthritis
• Knee Pain Chronic

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: 2017-06-19
• Primary completion: 2017-12-07
• Completion: 2017-12-07
• First posted: 2017-06-09
• Last updated: 2022-08-09
• Results posted: 2022-08-08

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study