NCT02837900

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: OrthoTrophix, Inc · Industry
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	TPX-100 200 mg 4 times weekly for 4 weeks	Ea. subject will received active TPX-100 200mg in the Left knee
DRUG	TPX-100 200 mg 4 times weekly for 4 weeks	TPX-100 100mg Right

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-08-01
• Completion: 2017-08-01
• First posted: 2016-07-20
• Last updated: 2017-09-19