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A Study to Evaluate the Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

Knee Osteoarthritis Clinical Trial

Official title:
A Phase 3 Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients With Osteoarthritis of the Knee

Clinical Trial Summary

This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.

Clinical Trial Description

This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study of ASA in patients with OA of the knee. Initially, 474 subjects are planned for inclusion in this study using a group sequential design with an interim analyses and a final analysis. Patients will be randomly assigned in a 1:1 ratio to receive a single intra-articular (IA) injection of 2 mL of ASA (plus 2 mL of normal saline) or 4 mL of normal saline on Day 1. They will have serial assessments of knee pain, function, and symptoms scores, as well as safety assessments for up to 52 weeks after administration of the study drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06000410
Study type Interventional
Source Organogenesis
Contact Clinical Trials Office
Phone 857-300-1167
Email ClinicalTrials@organo.com
Status Recruiting
Phase Phase 3
Start date September 6, 2023
Completion date March 2026
View Details
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