Osteoarthritis Hand
Conditions
Keywords
Osteoarthritis Hand
Brief summary
The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand osteoarthritis patients.
Detailed description
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.
Interventions
DRUGCelecoxib 100 MG
Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks
DRUGCelecoxib 200mg
Celecoxib 200mg, Oral, QD(once daily), During 6 weeks
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Assignment
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Agreement with written informed consent and 19 years of age and older * Patients history of OA of hand according to ACR criteria * The 100mm Pain VAS is over 40mm
Exclusion criteria
* History of OA of hand surgery * Intra-articular injections within 3 months * History of OA of hand infections within 3 months * Who had taken a drug that has a control of result in clinical trial by investigator's decision * Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods * clinically significant hepatic, renal, cardiovascular diseases * Any history of adverse reaction to the study drugs * Patients with gastrointestinal ulcers or bleeding disorders * Finger joint injury within 6 months * Who had following results after examination 1. K ≥ 5.5mEq/L 2. eGFR ≤ 30ml/min/1.73m\^2 * Patients on any other clinical trial or experimental treatment in the past 3 months * Taking narcotic analgesics or patches * History of drug abuse or alcoholism * Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders * An impossible one who participates in clinical trial by investigator's decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group | baseline, 6weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes in each item of K-AUSCAN at 6 weeks relative to the baseline value of each group | baseline, 6weeks |
| The total point change of K-AUSCAN at 6 weeks relative to the baseline value of each group | baseline, 6weeks |
| Total score change of insomnia severity at 6 weeks relative to the baseline value of each group | baseline, 6weeks |
| The total dose of acetaminophen for 6 weeks in each group | 6weeks |
| Percentage of subjects using acetaminophen for 6 weeks in each group | 6weeks |
| Total dosing days of acetaminophen for 6 weeks in each group | 6weeks |
Other
| Measure | Time frame |
|---|---|
| Safety assessed by the incidence of adverse event | up to 6weeks |
| laboratory test(Hematology test, Blood chemistry test, Urinalysis) | up to 6weeks |
Countries
South Korea
Outcome results
None listed