Are you healthy and looking to help advance medical science?

You may be eligible to participate in a osteoarthritis hand clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a osteoarthritis hand clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Osteoarthritis Hand Clinical Trial in Seoul

NCT03067194 | Phase 4 | Interventional

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a osteoarthritis hand clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a osteoarthritis hand clinical study, and could be compensated for your time.

Completed

Male & Female

19 Years +

This study has recruited 117 Participants

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

Show me more details

Details for the study

Brief Title

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

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

Brief Summary

The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand<br /> 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.

Treatments and/or Procedures

Celecoxib 200mg

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

Celecoxib 100 MG

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

Study 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

       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