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
NCT ID: NCT02837900
Last Updated: 2017-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
14 participants
INTERVENTIONAL
2016-08-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Previous LT TX knee and right placebo
Previous left treated knee will have placebo treatment in this protocol.
TPX-100 200 mg 4 times weekly for 4 weeks
Ea. subject will received active TPX-100 200mg in the Left knee
TPX-100 200 mg 4 times weekly for 4 weeks
TPX-100 100mg Right
Previous RT TX knee and left placebo
Previous right treated knee will have placebo treatment in this protocol.
TPX-100 200 mg 4 times weekly for 4 weeks
Ea. subject will received active TPX-100 200mg in the Left knee
TPX-100 200 mg 4 times weekly for 4 weeks
TPX-100 100mg Right
Both TX with Active
Both knees with receive Active
TPX-100 200 mg 4 times weekly for 4 weeks
Ea. subject will received active TPX-100 200mg in the Left knee
TPX-100 200 mg 4 times weekly for 4 weeks
TPX-100 100mg Right
Interventions
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TPX-100 200 mg 4 times weekly for 4 weeks
Ea. subject will received active TPX-100 200mg in the Left knee
TPX-100 200 mg 4 times weekly for 4 weeks
TPX-100 100mg Right
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cruciate and collateral ligament stability as defined by clinical examination
2. Able to read, understand, sign and date the subject informed consent
3. 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).
4. Willingness to use only hydrocodone or hydrocodone/acetaminophen (e.g. Norco) for breakthrough pain through study day 30.
5. Willingness not to use non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin, ibuprofen, naproxen through study day 30.
6. 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
2. 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
3. Prior surgery in the knees, excluding procedures for debridement only (no previous microfracture procedure)
4. Joint replacement or any other knee surgery planned in the next 12 months
5. History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis
6. 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)
* 3+ = So much fluid that it is not possible to move the effusion out of the medial aspect of the knee screening
7. Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee \< 3 months before screening
8. Last intra-articular knee injection of corticosteroids \< 2 months before screening
9. Use of any steroids (except inhaled corticosteroids for respiratory problems) during the previous month before screening
10. Known hypersensitivity to TPX-100
11. Known hypersensitivity to acetaminophen or hydrocodone
12. History of arthroscopy in either knee in the last 3 months before screening
13. History of septic arthritis, gout or pseudo-gout, of either knee in previous year before screening
14. Clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear)
15. Patellar chondrocalcinosis on X-Ray
16. Skin problem, rash or hypersensitivity, affecting either knee at the injection site
17. Bleeding problem, platelet or coagulation deficiency contraindicating, in the doctor's opinion, intra-articular injection
18. Active systemic infection
19. Current treatment or treatment within the previous 2 years prior to the Screening Visit for any malignancy except basal cell or squamous cell carcinoma of the skin, unless with specific written permission is provided by the Sponsor's medical monitor
20. Women of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period
21. Participation in other clinical osteoarthritis drug studies, with the exception of TPX-100-1, within one year prior to screening
22. Currently taking Paclitaxel (mitotic inhibitor), natalizumab (anti-integrin monoclonal antibody), or any other anti-integrin treatment.
23. History of significant liver disease or consumption of more than 3 alcoholic drinks a day. (Definition of one alcoholic drink: 12-ounces of beer, 8-ounces of malt liquor, 5-ounces of wine, 1.5-ounces or a "shot" of 80-proof distilled spirits or liquor such as gin, rum, vodka, or whiskey).
25 Years
75 Years
ALL
No
Sponsors
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OrthoTrophix, Inc
INDUSTRY
Responsible Party
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Other Identifiers
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TPX-100-2
Identifier Type: -
Identifier Source: org_study_id