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

Sponsor
Chong Kun Dang Pharmaceutical (Industry)
Overall Status
Completed
CT.gov ID
NCT03067194
Collaborator
(none)
117
Enrollment
1
Location
2
Arms
22.8
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Celecoxib 100 MG
  • Drug: Celecoxib 200mg
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
117 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
AssignmentAssignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Dec 27, 2016
Actual Primary Completion Date :
Jul 10, 2017
Actual Study Completion Date :
Nov 20, 2018

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

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

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

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

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

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

    Other Outcome Measures

    1. Safety assessed by the incidence of adverse event [up to 6weeks]

    2. laboratory test(Hematology test, Blood chemistry test, Urinalysis) [up to 6weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Soon Chun Hyang University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • 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 Cheonan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Chong Kun Dang Pharmaceutical
    ClinicalTrials.gov Identifier:
    NCT03067194
    Other Study ID Numbers:
    • 266HOA16008
    First Posted:
    Mar 1, 2017
    Last Update Posted:
    Jan 30, 2020
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Keywords provided by Chong Kun Dang Pharmaceutical
    Osteoarthritis Hand
    Additional relevant MeSH terms:
    Osteoarthritis
    Celecoxib

    Study Results

    No Results Posted as of Jan 30, 2020