NCT02242435

A Multiple Injection Study Evaluating Safety and Efficacy of Ampion in Osteoarthritis

A Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of Three Intra-articular Injections of Ampion™ (4 mL) Administered Two Weeks Apart in Adults With Pain Due to Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 342 (actual)
• Sponsor: Ampio Pharmaceuticals. Inc. · Industry
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of three intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Detailed description

A randomized, placebo-controlled, double-blinded study to evaluate the efficacy and safety of repeated intra-articular injections of Ampion™ in adult subjects with advanced osteoarthritis of the knee. The primary study objective was to evaluate the efficacy and safety from Baseline to Week 20 of 3 Ampion™ 4 mL intra-articular (IA) injections vs saline administered 2 weeks apart in improving knee pain in subjects suffering from osteoarthritis (OA) of the knee (OAK). The secondary study objective was to analyze the effect of Ampion 4 mL vs saline on a change in Patient's Global Assessment (PGA) and knee function from Baseline to Week 20.

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

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-04-01
• Completion: 2015-05-01
• First posted: 2014-09-17
• Last updated: 2022-09-15
• Results posted: 2022-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study