Knee OsteoarthritisPhase 2NCT02837900
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
A Phase 2 study testing TPX-100 200 mg 4 times weekly for 4 weeks in people with Knee Osteoarthritis, run by OrthoTrophix, Inc.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- TPX-100 200 mg 4 times weekly for 4 weeks
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- "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:
Show all 28Show fewer
- 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).
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- TPX-100 200 mg 4 times weekly for 4 weeks
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPX-100 200 mg 4 times weekly for 4 weeksDrug
Also called TPX-100 100mg Left
Ea. subject will received active TPX-100 200mg in the Left knee
TPX-100 200 mg 4 times weekly for 4 weeksDrug
Also called TPX-100 100mg Left
TPX-100 100mg Right
| Study group | Role | What they receive |
|---|---|---|
| Previous LT TX knee and right placebo | Placebo comparator | Previous left treated knee will have placebo treatment in this protocol. Receives: Drug: TPX-100 200 mg 4 times weekly for 4 weeks |
| Previous RT TX knee and left placebo | Placebo comparator | Previous right treated knee will have placebo treatment in this protocol. Receives: Drug: TPX-100 200 mg 4 times weekly for 4 weeks |
| Both TX with Active | Active comparator | Both knees with receive Active Receives: Drug: TPX-100 200 mg 4 times weekly for 4 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Safety, Tolerability and primary efficacy
Measured: Follow subjects for 6 months
Secondary outcomes (1)
Change in patellar cartilage thickness in each knee as measured on standardized MRI from baseline to 6 months.
Longitudinal changes in Patellar compartment cartilage thickness/thinness
Measured: Follow subjects for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoTrophix, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837900
- Sponsor's protocol ID
- TPX-100-2
- Status last verified
- Sep 2017
- First submitted
- 29 Jun 2016
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02837900
- Acronym / sponsor ID
- TPX-100-2
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- OrthoTrophix, IncIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 20 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Previous LT TX knee and right placebo | Placebo comparator | Drug: TPX-100 200 mg 4 times weekly for 4 weeksPrevious left treated knee will have placebo treatment in this protocol. |
| Previous RT TX knee and left placebo | Placebo comparator | Drug: TPX-100 200 mg 4 times weekly for 4 weeksPrevious right treated knee will have placebo treatment in this protocol. |
| Both TX with Active | Active comparator | Drug: TPX-100 200 mg 4 times weekly for 4 weeksBoth knees with receive Active |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (28 listed)
- "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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TPX-100 200 mg 4 times weekly for 4 weeksAlso: TPX-100 100mg LeftEa. subject will received active TPX-100 200mg in the Left knee | Drug | Both TX with Active, Previous LT TX knee and right placebo, Previous RT TX knee and left placebo |
| TPX-100 200 mg 4 times weekly for 4 weeksAlso: TPX-100 100mg LeftTPX-100 100mg Right | Drug | Both TX with Active, Previous LT TX knee and right placebo, Previous RT TX knee and left placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TPX-100 200 mg 4 times weekly for 4 weeks in people with Knee Osteoarthritis, run by OrthoTrophix, Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2017.