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

Chong Kun Dang

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis Hand

Treatments: Drug: Celecoxib 200mg; Drug: Celecoxib 100 MG

Study type: Interventional

Funder types: Industry

Identifiers

NCT03067194

266HOA16008

Details and patient eligibility

About

The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand osteoarthritis patients.

Full 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.

Enrollment: 117 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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117 participants in 2 patient groups

Celecoxib 100mg

Active Comparator group

Description:

Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks

Treatment:

Drug: Celecoxib 100 MG

Celecoxib 200mg

Active Comparator group

Description:

Celecoxib 200mg, Oral, QD(once daily), During 6 weeks

Treatment:

Drug: Celecoxib 200mg