The Study to Evaluate Efficacy and Safety of Celecoxib Capsule in Hand Osteoarthritis Patients

Study Overview
=================
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.

Official Title
-----------------
Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Celecoxib 200mg Capsule QD and Celecoxib 100mg BID in Hand Osteoarthritis Patients

Conditions
-----------------
Osteoarthritis Hand

Intervention / Treatment
-----------------
* Drug: Celecoxib 100 MG
* Drug: Celecoxib 200mg


Participation Criteria
=================
Eligibility Criteria
-----------------
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 K ≥ 5.5mEq/L 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Celecoxib 100mg<br>Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks | Drug: Celecoxib 100 MG<br>* Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks<br>* Other names: Celecoxib 100mg capsule;|
| Active Comparator: Celecoxib 200mg<br>Celecoxib 200mg, Oral, QD(once daily), During 6 weeks | Drug: Celecoxib 200mg<br>* Celecoxib 200mg, Oral, QD(once daily), During 6 weeks<br>* Other names: Celecoxib 200mg capsule;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group |  | baseline, 6weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 
| Total dosing days of acetaminophen for 6 weeks in each group |  | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis Hand