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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis Hand
• Intervention / Treatment: Drug: Celecoxib 100 MG; Drug: Celecoxib 200mg

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 Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Soon Chun Hyang University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Celecoxib 100mg; Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks	Drug: Celecoxib 100 MG; Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks; Other Names: Celecoxib 100mg capsule
Active Comparator: Celecoxib 200mg; Celecoxib 200mg, Oral, QD(once daily), During 6 weeks	Drug: Celecoxib 200mg; Celecoxib 200mg, Oral, QD(once daily), During 6 weeks; Other Names: Celecoxib 200mg capsule

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Safety assessed by the incidence of adverse event	up to 6weeks
laboratory test(Hematology test, Blood chemistry test, Urinalysis)	up to 6weeks

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Hyun Sook Kim, Soonchunhyang University Hospital; Principal Investigator: Chan Hong Jeon, Soonchunhyang University Hospital; Principal Investigator: Sung Hae Jang, Soonchunhyang University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2016
• Primary Completion (Actual): July 10, 2017
• Study Completion (Actual): November 20, 2018

Study Registration Dates

• First Submitted: February 3, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): January 30, 2020
• Last Update Submitted That Met QC Criteria: January 28, 2020
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Osteoarthritis Hand
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib
• Other Study ID Numbers: 266HOA16008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED