drugset / Trial / NCT02242435

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

NCT02242435 ↗

Phase 3 Completed 342 enrolled Ampio Pharmaceuticals. Inc.
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2014-09
Primary completion
2015-04
Completion
2015-05

Outcome

Missed primary endpoint

registry analysis (superiority test); Ampion 4 mL Injection vs Placebo 4 mL Injection; p = 0.26; ANCOVA; note: Adjusted for baseline WOMAC score. NCT02242435 ↗

Drugs

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

Indications