270 Participants Needed

TPX-100 for Knee Arthritis

MM
ER
Overseen ByErnest R. Kitt, BS MS
Prior Safety DataThis treatment has passed at least one previous human trial

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?

DM

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

Do you feel pain in your affected joints most days?
Has a doctor ever told you that X-rays show arthritis in your knee(s) or hip(s)?

Exclusion Criteria

Are you planning knee or hip surgery in the next year?
Has a doctor diagnosed you with rheumatoid arthritis, psoriatic arthritis, or gout?
Do you take daily opioids or medical cannabis for joint pain?
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive 4 weekly intra-articular injections of TPX-100 or placebo

4 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness with follow-up MRIs and PROs

49 weeks
3 visits (in-person), 1 tele-visit

What Are the Treatments Tested in This Trial?

Interventions

  • TPX-100
Trial Overview The study tests TPX-100 injections against a placebo in patients with knee osteoarthritis over 53 weeks. It aims to assess safety and effectiveness in reducing joint pain and improving function compared to a non-active treatment.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TPX-100 (200 mg per dose)Experimental Treatment1 Intervention
TPX-100 (200 mg per dose) for intra-articular injection administered once-weekly (Week 1, 2, 3 and 4) to a single target knee of the subject for 4 injections.
Group II: Placebo / PBSPlacebo Group1 Intervention
PBS placebo for intra-articular injection administered once-weekly (Week 1, 2, 3 and 4) to a single target knee of the subject for 4 injections.

Find a Clinic Near You

Who Is Running the Clinical Trial?

OrthoTrophix, Inc

Lead Sponsor

Trials
4
Recruited
460+
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security