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

Phase 4

Completed

• Conditions: Osteoarthritis Hand
• Interventions: Drug: Celecoxib 100 MG; Drug: Celecoxib 200mg

• Registration Number: NCT03067194
• Lead Sponsor: Chong Kun Dang Pharmaceutical

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.

Study Timeline

• Study Start: 2016-12-27
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-01
• Primary Completion: 2017-07-10
• Status Verified: 2018-11
• Study Completion: 2018-11-20
• Last Update Submitted: 2020-01-28
• Last Update Posted: 2020-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Celecoxib 100mg	Celecoxib 100 MG	Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks
Celecoxib 200mg	Celecoxib 200mg	Celecoxib 200mg, Oral, QD(once daily), During 6 weeks

Primary Outcome Measures

Name	Time	Method
The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group	baseline, 6weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Soon Chun Hyang University Hospital; 🇰🇷 Seoul, Korea, Republic of