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

Osteoarthritis of the Knee Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02242435
Study type Interventional
Source Ampio Pharmaceuticals. Inc.
Contact
Status Completed
Phase Phase 3
Start date September 2014
Completion date May 2015
View Details
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