TPX-100 for Knee Arthritis
What You Need to Know Before You Apply
What is the purpose of this trial?
53-Week Study Evaluating the Safety and Efficacy of Intra-articular (IA) Injections of TPX-100 vs Placebo in Subjects with Mild to Severe Tibio-Femoral Osteoarthritis of the Knee
Will I have to stop taking my current medications?
During the 4-week injection period, you can only use acetaminophen, hydrocodone, or hydrocodone/acetaminophen for pain relief. You must avoid non-steroidal anti-inflammatory drugs like aspirin, ibuprofen, or naproxen during this time.
Who Is on the Research Team?
Dawn McGuire - Chief Medical Officer, M.D. FAAN
Principal Investigator
OrthoTrophix, Inc
Are You a Good Fit for This Trial?
This trial is for adults aged 50-80 with mild to severe knee osteoarthritis, weighing less than 300 lbs. Participants must understand the study and consent to it. Exclusions include abnormal physical exam findings that affect compliance, extreme body temperatures, heart rate abnormalities, and lack of recent knee X-rays.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive 4 weekly intra-articular injections of TPX-100 or placebo
Follow-up
Participants are monitored for safety and effectiveness with follow-up MRIs and PROs
What Are the Treatments Tested in This Trial?
Interventions
- TPX-100
Find a Clinic Near You
Who Is Running the Clinical Trial?
OrthoTrophix, Inc
Lead Sponsor