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

NCT02024529 ↗

Phase 3 Completed 538 enrolled Ampio Pharmaceuticals. Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start: 2014-01
Primary completion: 2014-05
Completion: 2014-07

Outcome

Missed primary endpoint

registry analysis (superiority test); Ampion 4 mL Injection vs Placebo 4 mL Injection; p = 0.97; ANCOVA; note: Adjusted for baseline WOMAC score NCT02024529 ↗

Publications

Results Cole B, McGrath B, Salottolo K, Bar-Or D. LMWF-5A for the Treatment of Severe Osteoarthritis of the Knee: Integrated Analysis of Safety and Efficacy. Orthopedics. 2018 Jan 1;41(1):e77-e83. doi: 10.3928/01477447-20171114-05. Epub 2017 Nov 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASPARTYL-ALANYL-DIKETOPIPERAZINE	Protein / enzyme biologic	4 ml	Other