Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT00250458
Status:
COMPLETED
Last Update Posted:
2022-02-03
First Post:
2005-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'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': {'timeFrame': 'Reporting of adverse experiences from the time of informed consent to Visit 2. All serious adverse experiences that occur during this period and up to 14 days postdose of study therapy.', 'description': 'Number of subjects at risk included randomized subjects who had follow-up after at least one dose of study medication.', 'eventGroups': [{'id': 'EG000', 'title': 'Rizatriptan 10 mg', 'description': 'Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack', 'otherNumAtRisk': 200, 'otherNumAffected': 30, 'seriousNumAtRisk': 200, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack', 'otherNumAtRisk': 97, 'otherNumAffected': 4, 'seriousNumAtRisk': 97, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Lip swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Paraesthesia oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Stomatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Peripheral coldness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Muscle fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Musculoskeletal stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Dissociative disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Euphoric mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Pharyngeal hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Cold sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}, {'term': 'Hypoaesthesia facial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 200, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 97, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 9.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Elimination of Nausea at 2 Hours Postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rizatriptan 10 mg', 'description': 'Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack'}], 'classes': [{'title': 'No Nausea at 2 Hours', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Nausea at 2 Hours', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 2 hours after treatment', 'description': 'Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).'}, {'type': 'SECONDARY', 'title': 'Participants With Pain Relief at 2 Hours Postdose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '185', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rizatriptan 10 mg', 'description': 'Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack'}], 'classes': [{'title': '2-Hour Pain Relief', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}]}, {'title': 'No 2-Hour Pain Relief', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 hours after treatment', 'description': 'Participants reporting pain relief defined as a reduction of pain severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS population included all randomized and treated Participants who had at least one assessment within 2 hours post-dose (i.e., after baseline assessment).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rizatriptan 10 mg', 'description': 'Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '232'}, {'groupId': 'FG001', 'numSubjects': '114'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '200'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '17'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Lack of Migraine Attack', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Qualifying migraine but did not treat', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Twenty-Four (24) investigators in the United States\n\nPrimary Therapy Period: MAR06 to OCT06.', 'preAssignmentDetails': 'Each patient was to treat one migraine attack of moderate or severe intensity with accompanying nausea. Rescue medication was allowed for headache non-response or recurrence after 2 hours postdose. Patients were to treat a qualifying migraine attack within 3 months after randomization.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '232', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '346', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rizatriptan 10 mg', 'description': 'Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '65'}, {'value': '41', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '60'}, {'value': '40', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '65'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '207', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '310', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 346}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-01', 'studyFirstSubmitDate': '2005-11-07', 'resultsFirstSubmitDate': '2009-09-21', 'studyFirstSubmitQcDate': '2005-11-07', 'lastUpdatePostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-05-25', 'studyFirstPostDateStruct': {'date': '2005-11-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants With Elimination of Nausea at 2 Hours Postdose', 'timeFrame': 'At 2 hours after treatment', 'description': 'Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.'}], 'secondaryOutcomes': [{'measure': 'Participants With Pain Relief at 2 Hours Postdose', 'timeFrame': '2 hours after treatment', 'description': 'Participants reporting pain relief defined as a reduction of pain severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment.'}]}, 'conditionsModule': {'conditions': ['Migraine']}, 'referencesModule': {'references': [{'pmid': '18047500', 'type': 'BACKGROUND', 'citation': 'Freitag F, Taylor FR, Hamid MA, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Elimination of migraine-associated nausea in patients treated with rizatriptan orally disintegrating tablet (ODT): a randomized, double-blind, placebo-controlled study. Headache. 2008 Mar;48(3):368-77. doi: 10.1111/j.1526-4610.2007.00954.x. Epub 2007 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month\n\nExclusion Criteria:\n\n* Heart disease, high blood pressure'}, 'identificationModule': {'nctId': 'NCT00250458', 'briefTitle': 'Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea', 'organization': {'class': 'INDUSTRY', 'fullName': 'Organon and Co'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Elimination of Migraine-Associated Nausea in Migraine Patients Treated With Rizatriptan Orally Disintegrating Tablet (ODT)', 'orgStudyIdInfo': {'id': '0462-074'}, 'secondaryIdInfos': [{'id': '2005_081'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate', 'interventionNames': ['Drug: Comparator: Rizatriptan']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'matching placebo', 'interventionNames': ['Drug: Comparator: Placebo']}], 'interventions': [{'name': 'Comparator: Rizatriptan', 'type': 'DRUG', 'description': 'One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.', 'armGroupLabels': ['1']}, {'name': 'Comparator: Placebo', 'type': 'DRUG', 'description': 'One dose matching placebo to Rizatriptan to treat one migraine attack.', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Organon and Co', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}