Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-27 @ 10:38 AM
Study NCT ID:
NCT03067194
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2017-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study to Evaluate Efficacy and Safety of Celecoxib Capsule in Hand Osteoarthritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 117}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2017-02-03', 'studyFirstSubmitQcDate': '2017-02-24', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety assessed by the incidence of adverse event', 'timeFrame': 'up to 6weeks'}, {'measure': 'laboratory test(Hematology test, Blood chemistry test, Urinalysis)', 'timeFrame': 'up to 6weeks'}], 'primaryOutcomes': [{'measure': 'The change of 100mm Pain VAS score at 6 weeks relative to the baseline value of each group', 'timeFrame': 'baseline, 6weeks'}], 'secondaryOutcomes': [{'measure': 'Changes in each item of K-AUSCAN at 6 weeks relative to the baseline value of each group', 'timeFrame': 'baseline, 6weeks'}, {'measure': 'The total point change of K-AUSCAN at 6 weeks relative to the baseline value of each group', 'timeFrame': 'baseline, 6weeks'}, {'measure': 'Total score change of insomnia severity at 6 weeks relative to the baseline value of each group', 'timeFrame': 'baseline, 6weeks'}, {'measure': 'Total dosing days of acetaminophen for 6 weeks in each group', 'timeFrame': '6weeks'}, {'measure': 'The total dose of acetaminophen for 6 weeks in each group', 'timeFrame': '6weeks'}, {'measure': 'Percentage of subjects using acetaminophen for 6 weeks in each group', 'timeFrame': '6weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Osteoarthritis Hand'], 'conditions': ['Osteoarthritis Hand']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy and safety of Celecoxib capsule in hand osteoarthritis patients.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Agreement with written informed consent and 19 years of age and older\n* Patients history of OA of hand according to ACR criteria\n* The 100mm Pain VAS is over 40mm\n\nExclusion Criteria:\n\n* History of OA of hand surgery\n* Intra-articular injections within 3 months\n* History of OA of hand infections within 3 months\n* Who had taken a drug that has a control of result in clinical trial by investigator's decision\n* Pregnant women, nursing mothers or Fertile women who not practice contraception with appropriate methods\n* clinically significant hepatic, renal, cardiovascular diseases\n* Any history of adverse reaction to the study drugs\n* Patients with gastrointestinal ulcers or bleeding disorders\n* Finger joint injury within 6 months\n* Who had following results after examination\n\n 1. K ≥ 5.5mEq/L\n 2. eGFR ≤ 30ml/min/1.73m\\^2\n* Patients on any other clinical trial or experimental treatment in the past 3 months\n* Taking narcotic analgesics or patches\n* History of drug abuse or alcoholism\n* Who has Galactose intolerance, LAPP lactose intolerance, glucose-galactose malabsorption or genetic disorders\n* An impossible one who participates in clinical trial by investigator's decision"}, 'identificationModule': {'nctId': 'NCT03067194', 'briefTitle': 'The Study to Evaluate Efficacy and Safety of Celecoxib Capsule in Hand Osteoarthritis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Open-label, Multicenter, Randomized Study to Assess the Efficacy and Safety of Celecoxib 200mg Capsule QD and Celecoxib 100mg BID in Hand Osteoarthritis Patients', 'orgStudyIdInfo': {'id': '266HOA16008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Celecoxib 100mg', 'description': 'Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks', 'interventionNames': ['Drug: Celecoxib 100 MG']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Celecoxib 200mg', 'description': 'Celecoxib 200mg, Oral, QD(once daily), During 6 weeks', 'interventionNames': ['Drug: Celecoxib 200mg']}], 'interventions': [{'name': 'Celecoxib 100 MG', 'type': 'DRUG', 'otherNames': ['Celecoxib 100mg capsule'], 'description': 'Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks', 'armGroupLabels': ['Celecoxib 100mg']}, {'name': 'Celecoxib 200mg', 'type': 'DRUG', 'otherNames': ['Celecoxib 200mg capsule'], 'description': 'Celecoxib 200mg, Oral, QD(once daily), During 6 weeks', 'armGroupLabels': ['Celecoxib 200mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Soon Chun Hyang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hyun Sook Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}, {'name': 'Chan Hong Jeon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}, {'name': 'Sung Hae Jang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Soonchunhyang University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}