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Completed

NCT Number: NCT03067194

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

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

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Key information

Conditions

Osteoarthritis Hand

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soon Chun Hyang University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Celecoxib 100 mg

Drug

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

Other names: Celecoxib 100mg capsule

Celecoxib 200mg

Drug

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

Other names: Celecoxib 200mg capsule

Primary outcomes

  1. The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group

    Time frame: baseline, 6weeks

Secondary outcomes

  1. Changes in each item of K-AUSCAN at 6 weeks relative to the baseline value of each group

    Time frame: baseline, 6weeks

  2. The total point change of K-AUSCAN at 6 weeks relative to the baseline value of each group

    Time frame: baseline, 6weeks

  3. Total score change of insomnia severity at 6 weeks relative to the baseline value of each group

    Time frame: baseline, 6weeks

  4. Total dosing days of acetaminophen for 6 weeks in each group

    Time frame: 6weeks

  5. The total dose of acetaminophen for 6 weeks in each group

    Time frame: 6weeks

  6. Percentage of subjects using acetaminophen for 6 weeks in each group

    Time frame: 6weeks

Other outcomes

  1. Safety assessed by the incidence of adverse event

    Time frame: up to 6weeks

  2. laboratory test(Hematology test, Blood chemistry test, Urinalysis)

    Time frame: up to 6weeks

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 1, 2017
Registry last updated
Jan 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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