A Randomized, Double-blind, Placebo-controlled, Study Evaluating the Safety and Efficacy of a Second Course of Intra-articular Injections of TPX-100 in Subjects Who Previously Received TPX-100 for Patellar Osteoarthritis Involving Both Knees
Overview
- Phase
- Phase 2
- Intervention
- TPX-100 200 mg 4 times weekly for 4 weeks
- Conditions
- Knee Osteoarthritis
- Sponsor
- OrthoTrophix, Inc
- Enrollment
- 14
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief 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.
Detailed Description
Recruit up to 70 subjects whom participated in protocol TPX-100-1. The opposing knee that was treated will be getting 200mg in 4 weekly injections. The knee that was treated in TPX-100-1 will get randomized to either 200mg dose or a placebo lookalike. The investigators will follow these subjects for 6 months. Two MRIs of bi-lateral knees will be assessed. Also collection of ADA samples at 4 time points through the 6 month period.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Previous enrollment in study TPX-100-1
- •Cruciate and collateral ligament stability as defined by clinical examination
- •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
- •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
- •Willingness not to use non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin, ibuprofen, naproxen through study day
- •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-
- •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:
- •Zero = No wave produced on downstroke
- •Trace = Small wave on medial side with downstroke
- •1+ = Larger bulge on medial side with downstroke
- •2+ = Effusion spontaneously returns to medial side after upstroke (no downstroke necessary)
Arms & Interventions
Both TX with Active
Both knees with receive Active
Intervention: TPX-100 200 mg 4 times weekly for 4 weeks
Previous LT TX knee and right placebo
Previous left treated knee will have placebo treatment in this protocol.
Intervention: TPX-100 200 mg 4 times weekly for 4 weeks
Previous RT TX knee and left placebo
Previous right treated knee will have placebo treatment in this protocol.
Intervention: TPX-100 200 mg 4 times weekly for 4 weeks
Outcomes
Primary Outcomes
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
Time Frame: Follow subjects for 6 months
Safety, Tolerability and primary efficacy
Secondary Outcomes
- Change in patellar cartilage thickness in each knee as measured on standardized MRI from baseline to 6 months.(Follow subjects for 6 months)