Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-29 @ 7:33 AM
Study NCT ID:
NCT01427803
Status:
COMPLETED
Last Update Posted:
2015-10-15
First Post:
2011-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Actual Use Trial of Naproxen Sodium
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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical-trials-contact@bayerhealthcare.com', 'title': 'Head Medical Affairs', 'organization': 'Bayer HealthCare LLC, Consumer Care'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '28 days', 'description': 'AEs were collected at the Follow-up telephone interview after completion of the 28 day Use Phase or sooner if they discontinued from the study. The safety population consisted of all participants who took product. Safety data from the two cohorts were pooled in one group as both cohorts received the same treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.', 'otherNumAtRisk': 745, 'otherNumAffected': 89, 'seriousNumAtRisk': 745, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 20, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 15, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'overdose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'diarrhea haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'viral infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'gallbladder disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}, {'term': 'hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 745, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Estimated Percentage of Misuse for Non-Therapeutic Reasons', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Patterns of Use cohort who took the product + Participants in Reason for Misuse cohort who completed interview'}, {'type': 'SECONDARY', 'title': 'Non-therapeutic Reasons for Misuse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Reason for Misuse cohort who misused the product due to non-therapeutic reasons were included in this analysis'}, {'type': 'SECONDARY', 'title': 'Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course', 'denoms': [{'units': 'Participants', 'counts': [{'value': '632', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by "use day". A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive "evaluable days."', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Patterns of Use cohort who took the product + Reasons for misuse interviewed population'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'Percentage of participants took \\>/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Patterns of Use User Population who had at least 10 use days of the product'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day', 'denoms': [{'units': 'Participants', 'counts': [{'value': '375', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'Percentage of participants who took product with mean daily use \\>/= 2 tablets /use day thus exceeding the label directions on any use day.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Patterns of Use User Population who had at least 10 use days of the product'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Patterns of Use cohort who took the product'}, {'type': 'SECONDARY', 'title': 'Percentage of Dosing Occasions Where More Than One Tablet Was Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}]}, {'units': 'Dosing occasions', 'counts': [{'value': '9895', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': 'Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.', 'unitOfMeasure': 'Percentage of dosing occasions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Dosing occasions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Participants in Patterns of Use cohort who took the product'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': "Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in Patterns of Use cohort who took the product'}, {'type': 'SECONDARY', 'title': 'Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '502', 'groupId': 'OG000'}]}, {'units': 'Dosing occasions', 'counts': [{'value': '9895', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Naproxen Sodium ER (BAYH6689)', 'description': 'Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.8', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '28 days', 'description': "Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection", 'unitOfMeasure': 'Percentage of dosing occasions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Dosing occasions', 'denomUnitsSelected': 'Participants', 'populationDescription': 'Participants in Patterns of Use cohort who took the product'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patterns of Use Cohort', 'description': 'A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.'}, {'id': 'FG001', 'title': 'Reasons for Misuse Cohort', 'description': 'A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions \\[took more than one tablet per dose or a subsequent dose less than 22 hours later\\]), and completed the reasons for misuse questions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '526'}, {'groupId': 'FG001', 'numSubjects': '252'}]}, {'type': 'Purchased Product', 'achievements': [{'comment': 'Only 516 participants used e-diary', 'groupId': 'FG000', 'numSubjects': '525'}, {'groupId': 'FG001', 'numSubjects': '252'}]}, {'type': 'Baseline Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '516'}, {'comment': 'only interviewed participants were assessed', 'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'Took Product', 'achievements': [{'comment': 'Those who took at least one dose of investigational product. Only 502 qualified for data analysis.', 'groupId': 'FG000', 'numSubjects': '508'}, {'comment': 'Those who took at least one dose of investigational product as logged in e diary \\& 1 on Health Log.', 'groupId': 'FG001', 'numSubjects': '237'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '463'}, {'comment': '130 participants interviewed. Remaining subjects continued in trial to collect safety information.', 'groupId': 'FG001', 'numSubjects': '226'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}, {'groupId': 'FG001', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Unable to complete full treatment period', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'did not take product', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '516', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '646', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Patterns of Use User Population', 'description': 'A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.'}, {'id': 'BG001', 'title': 'Reasons for Misuse Interviewed Population', 'description': 'A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions \\[took more than one tablet per dose or a subsequent dose less than 22 hours later\\]), and completed the reasons for misuse questions.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '12 to 17 Years', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': '18 to 24 Years', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': '25 to 34 Years', 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': '35 to 44 Years', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}]}]}, {'title': '45 to 54 Years', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '172', 'groupId': 'BG002'}]}]}, {'title': '55 Years or Older', 'categories': [{'measurements': [{'value': '202', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '257', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '295', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '363', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '221', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 778}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-24', 'studyFirstSubmitDate': '2011-08-31', 'resultsFirstSubmitDate': '2013-02-05', 'studyFirstSubmitQcDate': '2011-09-01', 'lastUpdatePostDateStruct': {'date': '2015-10-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-04-09', 'studyFirstPostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated Percentage of Misuse for Non-Therapeutic Reasons', 'timeFrame': '28 days', 'description': 'The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.'}], 'secondaryOutcomes': [{'measure': 'Non-therapeutic Reasons for Misuse', 'timeFrame': '28 days', 'description': 'Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.'}, {'measure': 'Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course', 'timeFrame': '28 days', 'description': 'This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by "use day". A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive "evaluable days."'}, {'measure': 'Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days', 'timeFrame': '28 days', 'description': 'Percentage of participants took \\>/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.'}, {'measure': 'Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day', 'timeFrame': '28 days', 'description': 'Percentage of participants who took product with mean daily use \\>/= 2 tablets /use day thus exceeding the label directions on any use day.'}, {'measure': 'Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken', 'timeFrame': '28 days', 'description': 'Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.'}, {'measure': 'Percentage of Dosing Occasions Where More Than One Tablet Was Taken', 'timeFrame': '28 days', 'description': 'Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.'}, {'measure': 'Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose', 'timeFrame': '28 days', 'description': "Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection."}, {'measure': 'Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose', 'timeFrame': '28 days', 'description': "Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Actual Use Trial'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 12 years of age\n* Report taking OTC analgesics for pain on at least 5 days in the last month\n* Report having had pain at least once in the last 3 months lasting longer than 12 hours or that they believe would have lasted longer than 12 hours if they had not treated it\n* Able to read and understand English\n* Provide written informed consent (subjects 12-17 years of age provide written assent and/or parent or legal guardian provide written consent)\n* Provide contact information\n* Purchase the investigational product\n\nExclusion Criteria:\n\n* Have participated in a trial involving OTC analgesics in the last 6 months\n* They or someone else in the household work for a market research company, an advertising agency, a public relations firm, a pharmaceutical company, as a healthcare professional, or as part of a health care practice (eliminated for reasons of confidentiality or increased awareness of drugs and their labels)\n* Have a history of known allergies to NSAIDs (i.e., naproxen, ibuprofen, aspirin, etc.)\n* Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days\n* (Female subjects) are pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT01427803', 'acronym': 'Kiefer AUT', 'briefTitle': 'Actual Use Trial of Naproxen Sodium', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID', 'orgStudyIdInfo': {'id': '15647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'interventionNames': ['Drug: Naproxen Sodium ER (BAYH6689)']}], 'interventions': [{'name': 'Naproxen Sodium ER (BAYH6689)', 'type': 'DRUG', 'description': 'BAYH6689; oral tablet used as needed upon incidence of pain', 'armGroupLabels': ['Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35226', 'city': 'Hoover', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.40539, 'lon': -86.81138}}, {'zip': '35111-3406', 'city': 'McCalla', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.34872, 'lon': -87.01416}}, {'zip': '35126', 'city': 'Pinson', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.68899, 'lon': -86.68332}}, {'zip': '85202', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92054', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '92886', 'city': 'Yorba Linda', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.88863, 'lon': -117.81311}}, {'zip': '66209', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '21228', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '55304', 'city': 'Andover', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.2333, 'lon': -93.29134}}, {'zip': '55330', 'city': 'Elk River', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.30385, 'lon': -93.56718}}, {'zip': '55432', 'city': 'Fridley', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.08608, 'lon': -93.26328}}, {'zip': '55057-2434', 'city': 'Northfield', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.4583, 'lon': -93.1616}}, {'zip': '55068', 'city': 'Rosemount', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.73941, 'lon': -93.12577}}, {'zip': '55113', 'city': 'Roseville', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 45.00608, 'lon': -93.15661}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '64504', 'city': 'Saint Joseph', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.76861, 'lon': -94.84663}}, {'zip': '64485', 'city': 'Savannah', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.94166, 'lon': -94.83025}}, {'zip': '87104', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87107', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '87571', 'city': 'Taos', 'state': 'New Mexico', 'country': 'United States', 'geoPoint': {'lat': 36.40725, 'lon': -105.57307}}, {'zip': '84010', 'city': 'Bountiful', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.88939, 'lon': -111.88077}}, {'zip': '84737', 'city': 'Hurricane', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 37.17526, 'lon': -113.28995}}, {'zip': '84041', 'city': 'Layton', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 41.06022, 'lon': -111.97105}}, {'zip': '84401', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '84102', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84121', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '84075', 'city': 'Syracuse', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 41.08939, 'lon': -112.06467}}, {'zip': '84088', 'city': 'West Jordan', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.60967, 'lon': -111.9391}}, {'zip': '23192', 'city': 'Montpelier', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.37654, 'lon': -77.15942}}, {'zip': '23221', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98007', 'city': 'Bellevue', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.61038, 'lon': -122.20068}}, {'zip': '98028', 'city': 'Kenmore', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.75732, 'lon': -122.24401}}, {'zip': '98290', 'city': 'Snohomish', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.91288, 'lon': -122.09818}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}