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A Study Evaluating the Safety and Efficacy of a Second Course of TPX-100 in Subjects Who Previously Received TPX-100 for Patellar Osteoarthritis Involving Both Knees

Knee Osteoarthritis Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Safety and Efficacy of a Second Course of Intra-articular Injections of TPX-100 in Subjects Who Previously Received TPX-100 for Patellar Osteoarthritis Involving Both Knees

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, and preliminary efficacy of a second course of TPX-100 administered by intra-articular injection to subjects with osteoarthritis of the knee who participated in study TPX-100-1.

Clinical Trial Description

Recruit up to 70 subjects whom participated in protocol TPX-100-1. The opposing knee that was treated will be getting 200mg in 4 weekly injections. The knee that was treated in TPX-100-1 will get randomized to either 200mg dose or a placebo lookalike. The investigators will follow these subjects for 6 months. Two MRIs of bi-lateral knees will be assessed. Also collection of ADA samples at 4 time points through the 6 month period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02837900
Study type Interventional
Source OrthoTrophix, Inc
Contact
Status Completed
Phase Phase 2
Start date August 2016
Completion date August 2017
View Details
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