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Trial record 7 of 549 for:    Celecoxib

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

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ClinicalTrials.gov Identifier: NCT03067194
Recruitment Status : Unknown
Verified February 2017 by Chong Kun Dang Pharmaceutical.
Recruitment status was:  Recruiting
First Posted : March 1, 2017
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Tracking Information
First Submitted Date  ICMJE February 3, 2017
First Posted Date  ICMJE March 1, 2017
Last Update Posted Date March 1, 2017
Study Start Date  ICMJE December 2016
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group [ Time Frame: baseline, 6weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2017)
  • Changes in each item of K-AUSCAN at 6 weeks relative to the baseline value of each group [ Time Frame: baseline, 6weeks ]
  • The total point change of K-AUSCAN at 6 weeks relative to the baseline value of each group [ Time Frame: baseline, 6weeks ]
  • Total score change of insomnia severity at 6 weeks relative to the baseline value of each group [ Time Frame: baseline, 6weeks ]
  • Total dosing days of acetaminophen for 6 weeks in each group [ Time Frame: 6weeks ]
  • The total dose of acetaminophen for 6 weeks in each group [ Time Frame: 6weeks ]
  • Percentage of subjects using acetaminophen for 6 weeks in each group [ Time Frame: 6weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 24, 2017)
  • Safety assessed by the incidence of adverse event [ Time Frame: up to 6weeks ]
  • laboratory test(Hematology test, Blood chemistry test, Urinalysis) [ Time Frame: up to 6weeks ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Study to Evaluate Efficacy and Safety of Celecoxib Capsule in Hand Osteoarthritis Patients
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis Hand
Intervention  ICMJE
  • Drug: Celecoxib 100 MG
    Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks
    Other Name: Celecoxib 100mg capsule
  • Drug: Celecoxib 200mg
    Celecoxib 200mg, Oral, QD(once daily), During 6 weeks
    Other Name: Celecoxib 200mg capsule
Study Arms  ICMJE
  • Active Comparator: Celecoxib 100mg
    Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks
    Intervention: Drug: Celecoxib 100 MG
  • Active Comparator: Celecoxib 200mg
    Celecoxib 200mg, Oral, QD(once daily), During 6 weeks
    Intervention: Drug: Celecoxib 200mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 24, 2017)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2018
Estimated Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03067194
Other Study ID Numbers  ICMJE 266HOA16008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Chong Kun Dang Pharmaceutical
Study Sponsor  ICMJE Chong Kun Dang Pharmaceutical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Chong Kun Dang Pharmaceutical
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP