Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-29 @ 10:16 PM
Study NCT ID:
NCT02404532
Status:
COMPLETED
Last Update Posted:
2018-08-03
First Post:
2015-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '800 562-3974', 'title': 'Tim Peters-Strickland', 'organization': 'Otsuka Pharmaceutical Development & Commercialization, Inc'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'None reported'}}, 'adverseEventsModule': {'timeFrame': 'At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit)', 'description': 'Safety and tolerability was assessed by the frequency and severity of AEs, device-related AEs, SAEs, AEs leading to discontinuation, and unanticipated adverse device effects. Vital signs (heart rate and blood pressure) were analyzed as additional safety variables. The Safety sample included all participants who ingested at least 1 dose of a placebo + IEM, which is the same as the ITT dataset.', 'eventGroups': [{'id': 'EG000', 'title': 'MIND1 System IEM Detection (All Enrolled Participants)', 'description': 'On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device \\[eg, smartphone\\] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smartphone).', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Accuracy of Placebo-embedded IEM Detection by the MIND1 System Measured by the Percentage of Participants With IEM Detection Reported for Each of the 4 Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MIND1 System IEM Detection (All Enrolled Participants)', 'description': 'On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device \\[eg, smartphone\\] application) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time that was detected by the MIND1 system compatible computing device (eg, smartphone).'}], 'classes': [{'title': 'Hour 0', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Hour 2', 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}]}]}, {'title': 'Hour 4', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}, {'title': 'Hour 6', 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1 Visit, at hours 0, 2, 4, 6', 'description': 'All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the accuracy of IEM detection by the MIND1 System using the placebo + IEM by the proportion of participants with IEM detection reported for each of the 4 time points.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT sample included all participants who had ingested at least 1 dose of placebo-embedded IEM, regardless of whether or not ingestion was detected successfully.'}, {'type': 'PRIMARY', 'title': 'Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MIND1 System IEM Detection (All Enrolled Participants)', 'description': 'On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device \\[eg, smartphone\\] application) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time that was detected by the MIND1 system compatible computing device (eg, smartphone).'}], 'classes': [{'title': 'Hour 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 Visit at 0, 2, 4 and 6 hours', 'description': 'All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To evaluate the latency period between site-reported ingestion time and detection of the ingestion event by the patch which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT sample included all participants who had ingested at least 1 dose of placebo-embedded IEM, regardless of whether or not ingestion was detected successfully.'}, {'type': 'SECONDARY', 'title': 'The Latency Period Between the Patch Detection of an Ingestion Event (eg, the Acquisition Time Stamp) and the Detection of the Ingestion Event in the Otsuka Cloud Server (eg, Server Time Stamp).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Patch Acquisition of IEM to MDDS', 'description': 'The information transmission - Patch Acquisition of IEM to MDDS was measured at all four time points (Hour 0, 2, 4 and 6)'}, {'id': 'OG001', 'title': 'MDDS to Otsuka Software Application Registration', 'description': 'The information transmission - MDDS to Otsuka software application registration was measured at all four time points (Hour 0, 2, 4 and 6)'}, {'id': 'OG002', 'title': 'Otsuka Software Application Registration to Cloud Server', 'description': 'The information transmission - Otsuka software application registration to Cloud Server was measured at all four time points (Hour 0, 2, 4 and 6)'}, {'id': 'OG003', 'title': 'Patch Acquisition of IEM to Cloud Server', 'description': 'The information transmission - Patch acquisition of IEM to Cloud Server was measures at all four time points (Hour 0, 2, 4 and 6)'}], 'classes': [{'title': 'Hour 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.59', 'spread': '23.07', 'groupId': 'OG000'}, {'value': '1.85', 'spread': '6.38', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '7.46', 'spread': '23.67', 'groupId': 'OG003'}]}]}, {'title': 'Hour 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '9.74', 'spread': '21.16', 'groupId': 'OG000'}, {'value': '0.52', 'spread': '0.70', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '10.28', 'spread': '20.93', 'groupId': 'OG003'}]}]}, {'title': 'Hour 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.58', 'spread': '7.84', 'groupId': 'OG000'}, {'value': '2.62', 'spread': '7.48', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '6.21', 'spread': '10.36', 'groupId': 'OG003'}]}]}, {'title': 'Hour 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4.00', 'spread': '7.14', 'groupId': 'OG000'}, {'value': '2.21', 'spread': '6.60', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.01', 'groupId': 'OG002'}, {'value': '6.21', 'spread': '8.91', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 Visit at 0, 2, 4 and 6 hours', 'description': 'All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the latency period between the patch detection of an ingestion event and the detection of the ingestion event on the Otsuka Cloud Server which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline ingestion tile after each scheduled ingestion event. The various information transmissions measured were patch Acquisition of IEM to Medical Device Data Systems (MDDS), MDDS to Otsuka software application registration, Otsuka software application registration to Cloud Server and patch Acquisition of IEM to Cloud Server', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT sample included all participants who had ingested at least 1 dose of placebo-embedded IEM, regardless of whether or not ingestion was detected successfully.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With AEs Due Study Treatment and MIND1 System', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MIND1 System IEM Detection (All Enrolled Participants)', 'description': 'On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device \\[eg, smartphone\\] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smartphone).'}], 'classes': [{'title': 'All Treatment-Emergent Adverse Events (TEAEs)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-Emergent Serious AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serious Related TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs led to discontinuation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Number of death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit)', 'description': 'Safety and tolerability of the system components was assessed by the device-related AEs, non-serious AEs (NSAEs), serious AEs (SAEs), AEs leading to discontinuation, and unanticipated adverse device effects.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety sample included all participants who had ingested at least 1 dose of a placebo-embedded IEM, which was the same as the ITT dataset.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MIND1 System IEM Detection (All Enrolled Participants)', 'description': 'On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device \\[eg, smart phone\\] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded ingestible event marker (IEM) tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by the medical information device #1 (MIND1) system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smart phone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smart phone).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This sub-study was conducted on 29 healthy male and female participants at a single site (clinic) in United States (US). All enrolled participants received study treatment for 1 day (Visit 1), plus a 1-week (7 \\[+1\\] days after the last trial visit) safety follow-up period (via phone call).', 'preAssignmentDetails': 'A screening period of 14 days included various procedures such as informed consent form signing, urine pregnancy test, study eligibility review, vital signs measurement, medical history, concomitant medication, baseline \\& demographic data collection, physical measurement, drugs of abuse test \\& any adverse events (AEs) assessments.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'MIND1 System IEM Detection (All Enrolled Participants)', 'description': 'On Day 1, for all enrolled participants, a single adhesive patch (paired with the compatible computing device \\[eg, smartphone\\] app) was placed on torso (just above the left costal margin, anywhere from the xyphoid to the left mid-axillary line) before the ingestion of the first placebo-embedded IEM tablet. All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). Placebo-embedded IEM tablets were tested to measure the accuracy of IEM detection by MIND1 system. Clinic staff recorded the time of each ingestion of an IEM. Clinic staff checked the compatible computing device (eg, smart phone) at 30-minute intervals for the presence of a timeline ingestion tile and recorded the time it was detected by the MIND1 system compatible computing device (eg, smartphone).'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '29', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.0', 'spread': '15.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The enrolled sample included all participants who signed an informed consent form and entered the trial. The Intent-to-Treat (ITT) sample included all participants who ingested at least 1 dose of placebo + IEM, regardless of whether or not ingestion was detected successfully.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'dispFirstSubmitDate': '2016-02-01', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-02', 'studyFirstSubmitDate': '2015-03-05', 'dispFirstSubmitQcDate': '2016-02-01', 'resultsFirstSubmitDate': '2018-04-30', 'studyFirstSubmitQcDate': '2015-03-30', 'dispFirstPostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-02', 'studyFirstPostDateStruct': {'date': '2015-03-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Accuracy of Placebo-embedded IEM Detection by the MIND1 System Measured by the Percentage of Participants With IEM Detection Reported for Each of the 4 Time Points', 'timeFrame': 'Day 1 Visit, at hours 0, 2, 4, 6', 'description': 'All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the accuracy of IEM detection by the MIND1 System using the placebo + IEM by the proportion of participants with IEM detection reported for each of the 4 time points.'}, {'measure': 'Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch', 'timeFrame': 'Day 1 Visit at 0, 2, 4 and 6 hours', 'description': 'All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To evaluate the latency period between site-reported ingestion time and detection of the ingestion event by the patch which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline.'}], 'secondaryOutcomes': [{'measure': 'The Latency Period Between the Patch Detection of an Ingestion Event (eg, the Acquisition Time Stamp) and the Detection of the Ingestion Event in the Otsuka Cloud Server (eg, Server Time Stamp).', 'timeFrame': 'Day 1 Visit at 0, 2, 4 and 6 hours', 'description': 'All participants ingested one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions (hours 0, 2, 4, and 6). The time of each ingestion of an IEM was recorded. The compatible computing device (eg, smartphone) was checked at 30-minute intervals for the presence of a timeline ingestion tile and the time was recorded. To measure the latency period between the patch detection of an ingestion event and the detection of the ingestion event on the Otsuka Cloud Server which displayed on the MIND1 System compatible computing device (eg, smartphone) as a timeline ingestion tile after each scheduled ingestion event. The various information transmissions measured were patch Acquisition of IEM to Medical Device Data Systems (MDDS), MDDS to Otsuka software application registration, Otsuka software application registration to Cloud Server and patch Acquisition of IEM to Cloud Server'}, {'measure': 'Number of Participants With AEs Due Study Treatment and MIND1 System', 'timeFrame': 'At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit)', 'description': 'Safety and tolerability of the system components was assessed by the device-related AEs, non-serious AEs (NSAEs), serious AEs (SAEs), AEs leading to discontinuation, and unanticipated adverse device effects.'}]}, 'conditionsModule': {'keywords': ['OPC-14597 Digital', 'Aripiprazole', 'Medical Information Device #1 System (MIND1)', 'Ingestible Event Marker'], 'conditions': ['Device Latency']}, 'referencesModule': {'references': [{'pmid': '38085556', 'type': 'DERIVED', 'citation': 'Jan M, Coppin-Renz A, West R, Gallo CL, Cochran JM, Heumen EV, Fahmy M, Reuteman-Fowler JC. Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials. JMIR Form Res. 2023 Dec 12;7:e44768. doi: 10.2196/44768.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.', 'detailedDescription': 'The OSMITTER study protocol is designed as a master protocol governing multiple substudies for the rapid assessment of candidate subcomponents for the MIND1 System. This substudy is being conducted to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic. Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions.\n\nPlacebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Approximately 30 healthy volunteer subjects will be enrolled in the substudy. The duration of this substudy from Visit 1 (Day 1) to safety follow-up will be approximately 1 week, of which approximately 1 day will be allotted for active subject participation, plus a 1-week safety follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males or healthy non-pregnant females 18 to 65 years of age at the time of informed consent who are willing to either practice abstinence or 2 barrier methods of birth control or 1 barrier method and an oral contraceptive method.\n* Subject must be in good general health (not suffering from a serious chronic mental or physical disorder that has required or may in the near future require urgent medical care).\n* Body mass index between 19 to 32 kg/m2 (inclusive).\n\nExclusion Criteria:\n\n* Subject with a history of skin sensitivity to adhesive medical tape or metals.\n* Subject with a history or evidence of a medical condition that would expose him or her to an undue risk of a significant adverse event (AE) or interfere with assessments of safety during the course of the trial.\n* Subject has received any investigational product within the last 30 days.\n* Subject has a current history of drug or alcohol dependence that meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.\n* Subject has the presence of cognitive impairment.\n* Subject currently taking antipsychotic medication.\n* Subject with a terminal illness.\n* Subject with a history of chronic dermatitis.\n* Subject with a history of gastrointestinal surgery that could impair absorption.\n* Female subject who is breastfeeding and/or who has a positive serum pregnancy test result prior to receiving trial medications.\n* Sexually active women of childbearing potential (WOCBP) who will not commit to using 2 forms of approved birth control methods or who will not remain abstinent during this trial and for 30 days following the last dose of trial medication.\n* Sexually active males who will not commit to using 2 of the approved birth control methods or who will not remain abstinent for the duration of the trial and for 90 days following the last dose of trial medication.\n* No permanent physical residence.\n* A diastolic blood pressure reading \\>95 mm Hg or symptomatic hypotension.\n* Any subject who, in the opinion of the investigator, should not participate in the trial.'}, 'identificationModule': {'nctId': 'NCT02404532', 'acronym': 'OSMITTER', 'briefTitle': "Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)", 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'OSMITTER 316-13-206B Substudy: A Substudy to Measure the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1) System and Determine the Latency Period', 'orgStudyIdInfo': {'id': '316-13-206B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Device: MIND1 System']}], 'interventions': [{'name': 'MIND1 System', 'type': 'DEVICE', 'description': 'Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions. Subjects may eat as they wish over the course of the day. Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Clinic staff will record the time of each ingestion of an IEM. Clinic staff will check the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and will record the time it is detected by the MIND1 System compatible computing device (eg, smartphone).', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}], 'overallOfficials': [{'name': 'Timothy Peters-Strickland, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}