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Trials & Filings

Ampio Begins Dosing in Pivotal Trial

Ampion to test against OAK

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Ampio Pharmaceuticals has received IRB approval and FDA IND clearance for its 500-patient, Phase III pivotal trial of Ampion for the treatment for osteoarthritis of-the-knee (OAK), and patient enrollment and treatments have commenced.

The trial is a randomized, placebo (vehicle control)-controlled, double-blind study in which 500 patients with OAK will be randomized to Ampion 4 ml intra-articular injection or a 4 ml saline vehicle control. Similar to the initial Phase III trial, the primary endpoint will be assessed at 12 weeks following a single injection; in this case, Ampio will follow patients for 20 weeks.

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