RECRUITING

53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 With Mild to Severe Tibio-Femoral Osteoarthritis of the Knee

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Randomized, Double-blind, Placebo-controlled, 53-Week Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Severe Tibio- Femoral Osteoarthritis of the Knee

Quick Facts

Study Start:2025-05-10
Study Completion:2027-06-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06865079

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Meghan Miller, MSS
CONTACT
510-488-3832
meghan.miller@orthotrophix.com
Ernest R. Kitt, BS MS
CONTACT
510-488-3832
ernest.kitt@orthotrophix.com

Principal Investigator

Dawn McGuire - Chief Medical Officer, M.D. FAAN
STUDY_CHAIR
OrthoTrophix, Inc

Study Locations (Sites)

AMR Mobile
Mobile, Alabama, 36608
United States
Elite Clinical Network
Scottsdale, Arizona, 85260
United States
Noble Clinical Research
Tucson, Arizona, 85704
United States
Legent Orthopedic Hospital
Carrolton, California, 75006
United States
Medvin Clinical Research
Covina, California, 91722
United States
CORE Orthopaedic Medical Center
Encinitas, California, 92024
United States
Marvel Clinical Research (Elite Clinical Network)
Huntington Beach, California, 92647
United States
Medvin Clinical Research Center
Riverside, California, 92518
United States
Medvin Clinical Research Center
Tujunga, California, 91042
United States
Medvin Clinical Research Center
Whittier, California, 90602
United States
AMR Miami
Coral Gables, Florida, 33134
United States
K2 Medical Research
Maitland, Florida, 32751
United States
Hope Research Network
Medley, Florida, 33166
United States
Wellness Research Center
Miami, Florida, 33135
United States
Well Pharma Medical Research
Miami, Florida, 33173
United States
Las Mercedes Medical Research
Miami, Florida, 33196
United States
Drug Studies of America
Marietta, Georgia, 30060
United States
AMR Kansas City
Kansas City, Kansas, 64114
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160
United States
AMR Lexington
Lexington, Kentucky, 40509
United States
Mayo Clinic (Rochester)
Rochester, Minnesota, 55905
United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, 89030
United States
Albuquerque Clinical Trials
Albuquerque, New Mexico, 87102
United States
Hightower Clinical
Oklahoma City, Oklahoma, 73102
United States
University Orthopedics Center
Altoona, Pennsylvania, 16602
United States
University Orthopedics Center
State College, Pennsylvania, 16801
United States
AMR Knoxville
Knoxville, Tennessee, 37909
United States
Accurate Clinical Research, LLC
Baytown, Texas, 77521
United States
Texas Orthopedic Specialist
Bedford, Texas, 76021
United States
First Surgical Hospital
Bellaire, Texas, 77401
United States
Accurate Clinical Research
Houston, Texas, 77089
United States
CenExel
Salt Lake City, Utah, 84107
United States
Wasatch Clinical Research
Salt Lake City, Utah, 84107
United States

Collaborators and Investigators

Sponsor: OrthoTrophix, Inc

  • Dawn McGuire - Chief Medical Officer, M.D. FAAN, STUDY_CHAIR, OrthoTrophix, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-10
Study Completion Date2027-06-15

Study Record Updates

Study Start Date2025-05-10
Study Completion Date2027-06-15

Terms related to this study

Additional Relevant MeSH Terms

  • Osteoarthritis (OA) of the Knee