CompletedPhase 2

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

14 participantsStarted 2016-08

Plain-language 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.

Who can participate

Age range25 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Previous enrollment in study TPX-100-1
✓. Able to read, understand, sign and date the subject informed consent
✓. Willingness to use only acetaminophen as the primary analgesic (pain-relieving) study medication during the injection period and through study day 30. The maximum dose of acetaminophen must not exceed 2 grams/day (2000 mg per day).
✓. Willingness to use only hydrocodone or hydrocodone/acetaminophen (e.g. Norco) for breakthrough pain through study day 30.
✓. Willingness not to use non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin, ibuprofen, naproxen through study day 30.
✓. 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

✕. "Possibly, probably or definitely" drug-related SAEs in TPX-100-1; severe or ongoing "possibly, probably or definitely" related AEs in TPX-100-1.
✕. 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
✕. Prior surgery in the knees, excluding procedures for debridement only (no previous microfracture procedure)
✕. Joint replacement or any other knee surgery planned in the next 12 months
✕. History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis
✕. Knee effusion \> 2+ on the following clinical scale:
✕. Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee \< 3 months before screening
✕. Last intra-articular knee injection of corticosteroids \< 2 months before screening

What they're measuring

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0. evaluate the safety, tolerability, and preliminary efficacy of a second course of TPX-100 who participated in study TPX-100-1

Timeframe: Follow subjects for 6 months

Trial details

NCT IDNCT02837900

SponsorOrthoTrophix, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-08

View on ClinicalTrials.gov More Knee Osteoarthritis trials