Double-Blind,Randomized,Placebo-Controlled Efficacy & Safety Study of EUFLEXXA™ for Treatment of OA of the First CMC

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00423371
First received: January 17, 2007
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

This multicenter, double-blind, randomized, parallel-group, active-controlled trial will be performed in approximately 80 subjects with chronic idiopathic osteoarthritis (OA) of the first carpo-metacarpal joint (CMC).


Condition Intervention Phase
Osteoarthritis
Device: sodium hyaluronate
Device: placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EUFLEXXA™ for Treatment of Osteoarthritis (OA) of the First Carpometacarpal (CMC) Joint

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Mean change in pain scores as reported by the patient on the AUSCAN Index pain subscale [ Time Frame: weeks 0 and 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in stiffness and function scores as reported by the patient on the AUSCAN Index stillness and function subscale [ Time Frame: weeks 0 and 26 ] [ Designated as safety issue: No ]
  • Change in Patient Global Assessment of Symptoms measured by 100mm visual analog scale (VAS) [ Time Frame: Weeks 0 and 26 ] [ Designated as safety issue: No ]
  • Number of tablets of rescue medication used between visits [ Time Frame: Weeks 0 and 26 ] [ Designated as safety issue: No ]

Enrollment: 79
Study Start Date: December 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EUFLEXXA™ Device: sodium hyaluronate
EUFLEXXA™ is supplied in a single-dose syringe containing 20 mg/2 ml of 1% sodium hyaluronate. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4.
Other Name: EUFLEXXA™
Placebo Comparator: Placebo Device: placebo
Placebo is supplied in a disposable prefilled glass syringe. Each single-dose syringe will contain 2 mL of phosphate buffered saline. Each subject will receive three single dose injections into the target first CMC joint on study weeks 0, 2 and 4.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men or women ≥40 years of age
  2. Pain due to primary OA of the first CMC joint present for at least half the days of the previous month AND a mean combined pain score ≥ 30 mm out of 100 mm of the 5 pain questions on the AUSCAN Index Pain Subscale (See Appendix 1)
  3. A series of X-rays confirming OA of the first CMC joint of the target thumb obtained at screening with a stage of 2, 3, or 4 according to Grading Scale in Appendix 3.
  4. Ability and willingness to use only acetaminophen as the analgesic (rescue) study medication

    • The acetaminophen dose must not exceed 4 grams/day (4000 mg)
    • If subject has known chronic liver disease, the maximum dose of acetaminophen must not exceed 2 grams/day (2000 mg)
    • The subject must be willing and able to discontinue acetaminophen at least 24 hours prior to all study-specific visits
    • The study specific acetaminophen provided will only be used for thumb/joint pain.
  5. Willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions
  6. Signed study-specific Subject Informed Consent Form

Exclusion Criteria:

  1. Any major injury to the target thumb within the 6 months prior to the Screening Visit
  2. Anyone having Carpal Tunnel Syndrome (CTS), DeQuervain's tenosynovitis, trigger finger, or a ganglion cyst of the target hand ONLY IF there is evidence of extreme atrophy AND two-point average discrimination is greater than 10-mm, OR if the pain from these conditions renders the subject unable to objectively assess OA pain in the target hand
  3. Any surgery to the target joint within the 12 months prior to the Screening Visit
  4. Regular use of assistive devices such as a cane or crutch or a CTS brace
  5. Concomitant rheumatic disease (rheumatoid arthritis, lupus arthropathy, psoriatic arthritis)
  6. History of chondrocalcinosis in the target joint
  7. Gout exacerbation in any joint in the past 6 months
  8. X-ray findings of acute fractures, severe loss of bone density, and/or severe bone or joint deformity in the target joint
  9. Significant target joint infection or skin disorder/infection within the 3 months prior to study enrollment
  10. Known hypersensitivity to acetaminophen, EUFLEXXA™, or Phosphate Buffered Saline solution
  11. 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
  12. Recurrent medical history of severe allergic or immune-mediated reactions or other immune disorders
  13. Current treatment or treatment within the previous 2 years prior to the Screening Visit for any malignancy unless specific written permission is provided by the Sponsor (excluding basal cell or squamous cell carcinoma of the skin)
  14. Active liver disease based on liver profile of AST, ALT, and conjugated bilirubin >2 times the upper limit of normal
  15. Renal insufficiency based on serum creatinine >2.0 mg/dL
  16. Any clinically significant laboratory value based on clinical history that the Investigator feels may affect the study evaluation
  17. Any intercurrent chronic disease or condition that may interfere with the completion of the 6-month follow-up of the study, such as liver disease, severe coronary disease, drug abuse, disordered mental state, or other clinically significant condition
  18. Current alcoholism, and/or any known current addiction to pain medications
  19. Any clinically significant finding that would place the subject at health risk, impact the study, or affect the completion of the study
  20. Any psychiatric illness that would prevent comprehension of the details and nature of the study
  21. Participation in any experimental device study within 6 months prior to the Screening Visit, or an experimental drug study within 1 month prior to the Screening Visit
  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: NCT00423371

Locations
United States, Florida
All Florida Orthopedic Association
St. Petersburg, Florida, United States, 33703
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00423371     History of Changes
Other Study ID Numbers: 2006-02
Study First Received: January 17, 2007
Last Updated: May 18, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Ferring Pharmaceuticals:
first Carpometacarpal (CMC) Joint

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Viscosupplements
Protective Agents

ClinicalTrials.gov processed this record on October 19, 2014