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

Ferring Pharmaceuticals1 site in 1 country79 target enrollmentDecember 2006

ConditionsOsteoarthritis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Osteoarthritis
Sponsor: Ferring Pharmaceuticals
Enrollment: 79
Locations: 1
Primary Endpoint: Mean change in pain scores as reported by the patient on the AUSCAN Index pain subscale
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

September 2007

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ferring Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Men or women ≥40 years of age
•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)
•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
•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.
•Willingness and ability to complete efficacy and safety questionnaires and ability to read and understand study instructions
•Signed study-specific Subject Informed Consent Form

Exclusion Criteria

•Any major injury to the target thumb within the 6 months prior to the Screening Visit
•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
•Any surgery to the target joint within the 12 months prior to the Screening Visit
•Regular use of assistive devices such as a cane or crutch or a CTS brace
•Concomitant rheumatic disease (rheumatoid arthritis, lupus arthropathy, psoriatic arthritis)
•History of chondrocalcinosis in the target joint
•Gout exacerbation in any joint in the past 6 months
•X-ray findings of acute fractures, severe loss of bone density, and/or severe bone or joint deformity in the target joint
•Significant target joint infection or skin disorder/infection within the 3 months prior to study enrollment
•Known hypersensitivity to acetaminophen, EUFLEXXA™, or Phosphate Buffered Saline solution

Outcomes

Primary Outcomes

Mean change in pain scores as reported by the patient on the AUSCAN Index pain subscale

Time Frame: weeks 0 and 26

Secondary Outcomes

Mean change in stiffness and function scores as reported by the patient on the AUSCAN Index stillness and function subscale(weeks 0 and 26)
Change in Patient Global Assessment of Symptoms measured by 100mm visual analog scale (VAS)(Weeks 0 and 26)
Number of tablets of rescue medication used between visits(Weeks 0 and 26)