A Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees

April 19, 2017 updated by: OrthoTrophix, Inc

A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects With Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees

This one-year study is designed to investigate the safety and efficacy of TPX-100, a 23-amino acid chondrogenic peptide, delivered by intra-articular injection, in regeneration of knee cartilage in subjects with bilateral osteoarthritis of the knee.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States
        • C3 Clinical Research Associates

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:

  1. Age ≥ 25 and ≤ 75

  2. Patello-femoral osteoarthritis of both knees of mild to moderate severity with intact meniscus and ligamentous stability (cruciate and collateral ligaments)

    • Clinically, as determined by screening questionnaire and judgment of the Principal Investigator (may be supported by imaging studies of knees); confirmed by centrally read screening MRI of both knees indicating ICRS Grade 1-3, or ICRS Grade 4 with only focal defects, no greater than 1 cm.
    • Meniscus intact (MRI degenerative signal up to and including grade II acceptable)
    • Cruciate and collateral ligament stability as defined by clinical examination
  3. Able to read, understand, sign and date the subject informed consent
  4. Willingness to use only acetaminophen as the primary analgesic (pain-relieving) study medication. The maximum dose of acetaminophen must not exceed 4 grams/day (4000 mg per day).
  5. Willingness to use only hydrocodone/acetaminophen for breakthrough pain during the injection period (through study day 30).
  6. Willingness not to use non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin, ibuprofen, naproxen for the first 30 days of the study.
  7. 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:

  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
  2. ICRS grade greater than Grade 3, or Grade 4 focal defects greater than 1 cm, as confirmed by centrally-read screening MRI
  3. MRI evidence of inflammatory or hypertrophic synovitis
  4. Prior surgery in the knees, excluding procedures for debridement only (no microfracture)
  5. Joint replacement or any other knee surgery planned in the next 12 months
  6. History of rheumatoid arthritis, psoriatic arthritis, or any other autoimmune or infectious cause for arthritis

  7. 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
  8. Last viscosupplementation (e.g. Synvisc® or similar hyaluronic acid product) injected into either knee < 3 months before screening
  9. Last intra-articular knee injection of corticosteroids < 2 months before screening
  10. Use of any steroids (except inhaled corticosteroids for respiratory problems) during the previous month before screening
  11. Known hypersensitivity to TPX-100
  12. Known hypersensitivity to acetaminophen or hydrocodone
  13. History of arthroscopy in either knee in the last 3 months before screening
  14. History of septic arthritis, gout or pseudo-gout, of either knee in previous year before screening
  15. Clinical signs of acute meniscal tear (locking, new acute mechanical symptoms consistent with meniscal tear)
  16. Patellar chondrocalcinosis on X-Ray
  17. Skin problem, rash or hypersensitivity, affecting either knee at the injection site
  18. Bleeding problem, platelet or coagulation deficiency contraindicating, in the doctor's opinion, any intra-articular injection
  19. Active systemic infection
  20. 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
  21. 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
  22. Participation in other clinical osteoarthritis drug studies within one year prior to screening
  23. Currently taking Paclitaxel (mitotic inhibitor), and or Natalizumab (anti-integrin monoclonal antibody).
  24. 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: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: TPX-100 Cohort 1
Cohort 1 will be 20mg dose of TPX-100 in one randomized knee, compared to placebo treated knee
Drug: Placebo
Drug: TPX-100 20mg
Other Names:
  • 20mg of TPX-100
Placebo Comparator: TPX-100 Cohort 2
Cohort 2 will be 50mg dose of TPX-100 in one randomized knee compared to placebo treated knee
Drug: Placebo
Drug: TPX-100 50mg
Other Names:
  • 50mg of TPX-100
Placebo Comparator: TPX-100 Cohort 3
Cohort 3 will be 100mg dose of TPX-100 in one randomized knee compared to placebo treated knee
Drug: Placebo
Drug: TPX-100 100mg
Other Names:
  • 100mg of TPX-100
Placebo Comparator: TPX-100 Cohort 4
Cohort 4 will be 200mg dose of TPX-100 in one randomized knee, compared to placebo treated knee
Drug: Placebo
Drug: TPX-100 200mg
Other Names:
  • 200mg of TPX-100
Placebo Comparator: Part B
Part B will be 200mg dose of TPX-100 in one randomized knee, compared to placebo treated knee
Drug: Placebo
Drug: TPX-100 200mg
Other Names:
  • 200mg of TPX-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cartilage thickness in the patello-femoral compartment as measured on standardized MRI from baseline to 12 months
Time Frame: 12 months
Change in cartilage thickness in the patello-femoral compartment from baseline to 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrthoTrophix, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2014

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

August 15, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 19, 2013

Study Record Updates

Last Update Posted (Actual)

April 21, 2017

Last Update Submitted That Met QC Criteria

April 19, 2017

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPX-100

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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