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

Knee Osteoarthritis Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03182686
Study type Interventional
Source Ampio Pharmaceuticals. Inc.
Contact
Status Completed
Phase Phase 3
Start date June 19, 2017
Completion date December 7, 2017
View Details
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