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A Randomized, Controlled Study to Evaluate Efficacy and Safety of Intra-articular Ampion for Osteoarthritis Pain in Knee

Osteoarthritis of the Knee Clinical Trial

Official title:
A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of a Single Intra-articular Injection of Ampion in Adults With Pain Due to Osteoarthritis (OA) of the Knee

Clinical Trial Summary

This study will evaluate the efficacy of an Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Clinical Trial Description

A Randomized, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee. The primary study objective was to evaluate the efficacy of 4 mL Ampion versus 4 mL saline intra-articular (IA) injection in treating knee pain when administered to subjects suffering from osteoarthritis (OA) of the knee (OAK). The secondary study objectives included evaluation of the safety of an IA injection of Ampion vs saline, efficacy of IA injection of Ampion vs saline in improving knee function. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02024529
Study type Interventional
Source Ampio Pharmaceuticals. Inc.
Contact
Status Completed
Phase Phase 3
Start date January 2014
Completion date July 2014
View Details
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