Trial record 1 of 2 for:    TPX-100
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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by OrthoTrophix, Inc
Sponsor:
Information provided by (Responsible Party):
OrthoTrophix, Inc
ClinicalTrials.gov Identifier:
NCT01925261
First received: August 15, 2013
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Knee Osteoarthritis
Drug: TPX-100 50mg
Drug: TPX-100 100mg
Drug: TPX-100 200mg
Drug: TPX-100 20mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by OrthoTrophix, Inc:

Primary Outcome Measures:
  • Change in cartilage thickness in the patello-femoral compartment as measured on standardized MRI from baseline to 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Change in cartilage thickness in the patello-femoral compartment from baseline to 12 months


Estimated Enrollment: 120
Study Start Date: January 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: TPX-100 20mg
Other Name: 20mg of TPX-100
Drug: Placebo
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: TPX-100 50mg
Other Name: 50mg of TPX-100
Drug: Placebo
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: TPX-100 100mg
Other Name: 100mg of TPX-100
Drug: Placebo
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: TPX-100 200mg
Other Name: 200mg of TPX-100
Drug: Placebo

  Eligibility

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925261

Contacts
Contact: Ron Carozza, Pharm D (206) 686-4644 Rcarozza@c3-research.com
Contact: Meghan Miller, MS 510-488-3827 meghan.miller@orthotrophix.com

Locations
United States, California
Medvin Research Recruiting
Covina, California, United States, 91723
Contact: Renne Garcia       Renee@medvinresearch.com   
Contact: Vipul Vineet       vipul@medvinresearch.com   
Principal Investigator: Samy Metyas, MD         
CORE Orthopaedic Medical Center Recruiting
Encinitas, California, United States, 92024
Contact: Farouk A Awad    760-943-6710 ext 162    fawad@coreorthopaedic.com   
Principal Investigator: Michael J Skyhar, MD         
Arthritis Care and Research Center Active, not recruiting
Poway, California, United States, 92064
UC Davis Center for Musculoskeletal Health Recruiting
Sacramento, California, United States, 95827
Contact: Denise Macias    916-734-8538    denise.macias@ucdmc.ucdavis.edu   
Contact: Andrea Nunez    9167344536    andrea.nunez@ucdmc.ucdavis.edu   
Principal Investigator: Nancy Lane, MD         
Dr. Hans Richard Barthel Recruiting
Santa Barbara, California, United States, 93108
Contact: Sharyn Plunkett       splunkett@sbcr.net   
Principal Investigator: Hans R Barthel, MD         
Sponsors and Collaborators
OrthoTrophix, Inc
  More Information

No publications provided

Responsible Party: OrthoTrophix, Inc
ClinicalTrials.gov Identifier: NCT01925261     History of Changes
Other Study ID Numbers: TPX-100
Study First Received: August 15, 2013
Last Updated: September 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by OrthoTrophix, Inc:
knee osteoarthritis
bilateral
osteoarthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 20, 2014