A Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects W… (NCT01925261) | Clinical Trial Compass
CompletedPhase 2
A Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees
United States120 participantsStarted 2014-01
Plain-language summary
This one-year study is designed to investigate the safety and efficacy of TPX-100, a 23-amino acid chondrogenic peptide, delivered by intra-articular injection, in regeneration of knee cartilage in subjects with bilateral osteoarthritis of the knee.
Who can participate
Age range25 Years – 75 Years
SexALL
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Inclusion criteria
✓. Age ≥ 25 and ≤ 75
✓. Patello-femoral osteoarthritis of both knees of mild to moderate severity with intact meniscus and ligamentous stability (cruciate and collateral ligaments)
✓. Able to read, understand, sign and date the subject informed consent
✓. Willingness to use only acetaminophen as the primary analgesic (pain-relieving) study medication. The maximum dose of acetaminophen must not exceed 4 grams/day (4000 mg per day).
✓. Willingness to use only hydrocodone/acetaminophen for breakthrough pain during the injection period (through study day 30).
✓. Willingness not to use non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin, ibuprofen, naproxen for the first 30 days of the study.
✓. Female subjects of child bearing potential who are sexually active (non-abstinent) must agree to and comply with using 2 highly effective methods of birth control (oral contraceptive, implant, injectable or indwelling intrauterine device, condom with spermicide, or sexual abstinence) while participating in the study.
Exclusion criteria
✕. Contraindication to MRI, including: metallic fragments, clips or devices in the brain, eye, or spinal canal; implanted devices that are magnetically programmed; weight \> 300 lbs.; moderate or severe claustrophobia; previous intolerance of MRI procedure
✕. ICRS grade greater than Grade 3, or Grade 4 focal defects greater than 1 cm, as confirmed by centrally-read screening MRI
What they're measuring
1
Change in cartilage thickness in the patello-femoral compartment as measured on standardized MRI from baseline to 12 months