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

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

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.

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