Double-Blind,Randomized,Placebo-Controlled Efficacy & Safety Study of EUFLEXXA™ for Treatment of … (NCT00423371) | Clinical Trial Compass
CompletedPhase 2/3
Double-Blind,Randomized,Placebo-Controlled Efficacy & Safety Study of EUFLEXXAâ„¢ for Treatment of OA of the First CMC
United States79 participantsStarted 2006-12
Plain-language 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).
Who can participate
Age range40 Years
SexALL
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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 3.
✓. Ability and willingness to use only acetaminophen as the analgesic (rescue) study medication
✓. 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
What they're measuring
1
Mean change in pain scores as reported by the patient on the AUSCAN Index pain subscale