The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand osteoarthritis patients.
This is a six-weeks, open-label, multi-center, randomized study. Patients take Celecoxib 200mg capsule once a day or Celecoxib 100mg capsules twice per day. If patients do not tolerate the pain, they are able to take Acetaminophen as a rescue medication during 6 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
117
Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks
Celecoxib 200mg, Oral, QD(once daily), During 6 weeks
Soon Chun Hyang University Hospital
Seoul, South Korea
The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group
Time frame: baseline, 6weeks
Changes in each item of K-AUSCAN at 6 weeks relative to the baseline value of each group
Time frame: baseline, 6weeks
The total point change of K-AUSCAN at 6 weeks relative to the baseline value of each group
Time frame: baseline, 6weeks
Total score change of insomnia severity at 6 weeks relative to the baseline value of each group
Time frame: baseline, 6weeks
Total dosing days of acetaminophen for 6 weeks in each group
Time frame: 6weeks
The total dose of acetaminophen for 6 weeks in each group
Time frame: 6weeks
Percentage of subjects using acetaminophen for 6 weeks in each group
Time frame: 6weeks
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