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

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

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
Osteoarthritis Hand 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Assignment
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
Study Start Date : December 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Celecoxib

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 Name: 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 Name: Celecoxib 200mg capsule




Primary Outcome Measures :
  1. The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group [ Time Frame: baseline, 6weeks ]

Secondary Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067194


Contacts
Contact: Hyun Sook Kim 82-2-709-9180 healthyra@schmc.ac.kr

Locations
Korea, Republic of
Soon Chun Hyang University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyun-sook Kim, PhD       healthyra@schmc.ac.kr   
Principal Investigator: Hyunsook Kim         
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

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03067194     History of Changes
Other Study ID Numbers: 266HOA16008
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chong Kun Dang Pharmaceutical:
Osteoarthritis Hand

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents