drugset / Trial / NCT02556710

A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

NCT02556710 ↗

Phase 3 Completed 480 enrolled Ampio Pharmaceuticals. Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

This study will evaluate the efficacy and safety of an intra-articular injection of AMPION™ in adults with pain due to osteoarthritis of the knee

Timeline

Start
2015-09
Primary completion
2016-06
Completion
2016-06

Outcome

Missed primary endpoint

registry analysis (superiority test); 4 mL AMPION™ vs 4 mL Saline Placebo; p = 0.94; ANCOVA NCT02556710 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject ASPARTYL-ALANYL-DIKETOPIPERAZINE Protein / enzyme biologic 4 ml Other

Indications