- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02837900
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
September 18, 2017 updated by: OrthoTrophix, Inc
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Phase 2
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.
Eligibility Criteria
Ages Eligible for Study
25 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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:
- 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
- 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
- Use of any steroids (except inhaled corticosteroids for respiratory problems) during the previous month before screening
- Known hypersensitivity to TPX-100
- Known hypersensitivity to acetaminophen or hydrocodone
- History of arthroscopy in either knee in the last 3 months before screening
- History of septic arthritis, gout or pseudo-gout, of either knee in previous year before screening
- Clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear)
- Patellar chondrocalcinosis on X-Ray
- Skin problem, rash or hypersensitivity, affecting either knee at the injection site
- Bleeding problem, platelet or coagulation deficiency contraindicating, in the doctor's opinion, intra-articular injection
- Active systemic infection
- 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
- 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
- Participation in other clinical osteoarthritis drug studies, with the exception of TPX-100-1, within one year prior to screening
- Currently taking Paclitaxel (mitotic inhibitor), natalizumab (anti-integrin monoclonal antibody), or any other anti-integrin treatment.
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Previous LT TX knee and right placebo
Previous left treated knee will have placebo treatment in this protocol.
|
Ea. subject will received active TPX-100 200mg in the Left knee
Other Names:
TPX-100 100mg Right
Other Names:
|
Placebo Comparator: Previous RT TX knee and left placebo
Previous right treated knee will have placebo treatment in this protocol.
|
Ea. subject will received active TPX-100 200mg in the Left knee
Other Names:
TPX-100 100mg Right
Other Names:
|
Active Comparator: Both TX with Active
Both knees with receive Active
|
Ea. subject will received active TPX-100 200mg in the Left knee
Other Names:
TPX-100 100mg Right
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Follow subjects for 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patellar cartilage thickness in each knee as measured on standardized MRI from baseline to 6 months.
Time Frame: Follow subjects for 6 months
|
Longitudinal changes in Patellar compartment cartilage thickness/thinness
|
Follow subjects for 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
August 1, 2017
Study Completion (Actual)
August 1, 2017
Study Registration Dates
First Submitted
June 29, 2016
First Submitted That Met QC Criteria
July 15, 2016
First Posted (Estimate)
July 20, 2016
Study Record Updates
Last Update Posted (Actual)
September 19, 2017
Last Update Submitted That Met QC Criteria
September 18, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TPX-100-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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