Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-02-21 @ 10:10 AM
Study NCT ID:
NCT00945035
Status:
COMPLETED
Last Update Posted:
2022-02-09
First Post:
2009-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077613', 'term': 'Etoricoxib'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck, Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Although a subject/patient may have had two or more clinical adverse experiences, the subject/patient is counted only once within a category. The same subject/patient may appear in different categories.', 'eventGroups': [{'id': 'EG000', 'title': 'Etoricoxib FMI', 'description': 'FMI Formulation (20%), Final Market Image', 'otherNumAtRisk': 36, 'otherNumAffected': 9, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Etoricoxib URC', 'description': 'URC Formulation (30%), Unmilled Roller Compaction', 'otherNumAtRisk': 36, 'otherNumAffected': 12, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Loose Stools', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 12.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib FMI', 'description': 'FMI Formulation (20%), Final Market Image.'}, {'id': 'OG001', 'title': 'Etoricoxib URC', 'description': 'URC Formulation (30%), Unmilled Roller Compaction'}], 'classes': [{'categories': [{'measurements': [{'value': '32.65', 'spread': '16.20', 'groupId': 'OG000'}, {'value': '33.28', 'spread': '13.65', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Ratio', 'ciPctValue': '90', 'paramValue': '1.02', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.07', 'groupDescription': 'Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \\[GMR\\] no less than 0.8 and no greater than 1.25).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Through 120 Hours Postdose', 'description': 'The area under the plasma concentration vs time curve.', 'unitOfMeasure': 'µg times hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All healthy adult subjects completed the study and were included in the statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Peak Plasma Concentration (Cmax) for Etoricoxib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etoricoxib FMI', 'description': 'FMI Formulation (20%), Final Market Image.'}, {'id': 'OG001', 'title': 'Etoricoxib URC', 'description': 'URC Formulation (30%), Unmilled Roller Compaction'}], 'classes': [{'categories': [{'measurements': [{'value': '1964', 'spread': '701', 'groupId': 'OG000'}, {'value': '2021', 'spread': '833', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Ratio', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.11', 'groupDescription': 'Least-Squares Mean Ratio (B/A); A=FMI Formulation (20%), Final Market Image; B=URC Formulation (30%), Unmilled Roller Compaction', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'Study Primary Hypothesis: The plasma etoricoxib AUC(0-∞) and Cmax values following a single-dose administration of the 120 mg etoricoxib (30%) URC formulation will be bioequivalent to the plasma AUC(0-∞) and Cmax of 120 mg etoricoxib (20%) in the FMI formulation following single-dose administration (geometric mean ratio \\[GMR\\] no less than 0.8 and no greater than 1.25).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Through 120 Hours Postdose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All healthy adult subjects completed the study and were included in the statistical analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etoricoxib FMI Then Etoricoxib URC', 'description': 'FMI Formulation (20%), Final Market Image/ URC Formulation (30%), Unmilled Roller Compaction'}, {'id': 'FG001', 'title': 'Etoricoxib URC Then Etoricoxib FMI', 'description': 'URC Formulation (30%), Unmilled Roller Compaction/ FMI Formulation (20%), Final Market Image'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants in Study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.1', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '44'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '168.3', 'groupId': 'BG000', 'lowerLimit': '149.9', 'upperLimit': '193.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '75.2', 'groupId': 'BG000', 'lowerLimit': '50.5', 'upperLimit': '99.1'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2009-07-22', 'resultsFirstSubmitDate': '2009-10-13', 'studyFirstSubmitQcDate': '2009-07-22', 'lastUpdatePostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-10-13', 'studyFirstPostDateStruct': {'date': '2009-07-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Area Under the Curve (AUC(0 to Infinity)) for Etoricoxib', 'timeFrame': 'Through 120 Hours Postdose', 'description': 'The area under the plasma concentration vs time curve.'}, {'measure': 'Peak Plasma Concentration (Cmax) for Etoricoxib', 'timeFrame': 'Through 120 Hours Postdose'}]}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'This study will establish the bioequivalence of the 20%, milled, roller compaction final market image (FMI) etoricoxib tablets and 30% unmilled, roller compaction (UMC) etoricoxib tablets.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is in good health\n* Subject agrees to follow the study guidelines\n\nExclusion Criteria:\n\n* Subject is a smoker\n* Subject has a history of adverse reactions caused by NSAIDs or allergies/intolerance to NSAIDs\n* Subject is in a situation or has a condition/disease which may interfere with optimal participation in the study'}, 'identificationModule': {'nctId': 'NCT00945035', 'briefTitle': 'Study of the Bioequivalence of the 20% and 30% Etoricoxib Tablet Formulations (0663-070)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'An Open-Label, Randomized, 2-Period, Single-Dose, Balanced, Crossover Study in Healthy Subjects to Establish the Bioequivalence of the 20% and 30% Etoricoxib (MK0663) Formulations', 'orgStudyIdInfo': {'id': '0663-070'}, 'secondaryIdInfos': [{'id': 'MK0663-070'}, {'id': '2009_623'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A', 'description': 'Etoricoxib, 20% tablet', 'interventionNames': ['Drug: etoricoxib']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Etoricoxib, 30% tablet', 'interventionNames': ['Drug: Comparator: etoricoxib']}], 'interventions': [{'name': 'etoricoxib', 'type': 'DRUG', 'description': 'Single dose etoricoxib 120 mg 20% final market image tablet in one of two treatment periods.', 'armGroupLabels': ['A']}, {'name': 'Comparator: etoricoxib', 'type': 'DRUG', 'description': 'Single dose etoricoxib 120 mg 30% unmilled, roller compaction tablet in one of two treatment periods.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}