Ignite Creation Date:
2025-12-25 @ 12:21 AM
Ignite Modification Date:
2025-12-25 @ 10:25 PM
Study NCT ID:
NCT00142558
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2005-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout (0663-081)(COMPLETED)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['China']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077613', 'term': 'Etoricoxib'}, {'id': 'D000081206', 'term': 'Duration of Therapy'}], 'ancestors': [{'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2005-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient assessment of pain (0- to 4- Likert scale)'}], 'secondaryOutcomes': [{'measure': 'Patient Global Assessment of Response to Therapy (0- to 4- point scale)'}, {'measure': 'Investigator Global Assessment of Response to Therapy (0- to 4- point scale)'}, {'measure': 'Tenderness of the study joint (0- to 3-point scale)'}, {'measure': 'Swelling of the study joint (0- to 3-point scale)'}]}, 'conditionsModule': {'keywords': ['Arcoxia'], 'conditions': ['Acute Gout']}, 'referencesModule': {'references': [{'pmid': '17588299', 'type': 'DERIVED', 'citation': 'Navarra S, Rubin BR, Yu Q, Smugar SS, Tershakovec AM. Association of baseline disease and patient characteristics with response to etoricoxib and indomethacin for acute gout. Curr Med Res Opin. 2007 Jul;23(7):1685-91. doi: 10.1185/030079907x210750.'}]}, 'descriptionModule': {'briefSummary': 'A study to evaluate the effects of etoricoxib and indomethacin in the treatment of acute gout.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females at least 18 years of age who have acute gout.'}, 'identificationModule': {'nctId': 'NCT00142558', 'briefTitle': 'A Study Evaluating the Effect of Etoricoxib and Indomethacin in the Treatment of Acute Gout (0663-081)(COMPLETED)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Randomized, Double-Blind, Active-Comparator-Controlled 5-Day Trial of the Effect of Etoricoxib 120 mg Versus Indomethacin 150 mg in the Treatment of Acute Gout', 'orgStudyIdInfo': {'id': '0663-081'}, 'secondaryIdInfos': [{'id': 'MK0663-081'}, {'id': '2005_062'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MK0663; etoricoxib / Duration of Treatment: 5 Days', 'type': 'DRUG'}, {'name': 'Comparator: indomethacin 75 mg sustained release capsule / Duration of Treatment: 5 Days', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}