Trial Outcomes & Findings for Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1) (NCT NCT02404532)
NCT ID: NCT02404532
Last Updated: 2018-08-03
Results Overview
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.
COMPLETED
PHASE4
30 participants
Day 1 Visit, at hours 0, 2, 4, 6
2018-08-03
Participant Flow
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).
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.
Participant milestones
| Measure |
MIND1 System IEM Detection (All Enrolled Participants)
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).
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|---|---|
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Overall Study
STARTED
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29
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Overall Study
COMPLETED
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29
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
Baseline characteristics by cohort
| Measure |
MIND1 System IEM Detection (All Enrolled Participants)
n=29 Participants
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).
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|---|---|
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Age, Continuous
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43.0 years
STANDARD_DEVIATION 15.2 • n=5 Participants
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Sex: Female, Male
Female
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14 Participants
n=5 Participants
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Sex: Female, Male
Male
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15 Participants
n=5 Participants
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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29 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Day 1 Visit, at hours 0, 2, 4, 6Population: 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.
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.
Outcome measures
| Measure |
MIND1 System IEM Detection (All Enrolled Participants)
n=29 Participants
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).
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MDDS to Otsuka Software Application Registration
The information transmission - MDDS to Otsuka software application registration was measured at all four time points (Hour 0, 2, 4 and 6)
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Otsuka Software Application Registration to Cloud Server
The information transmission - Otsuka software application registration to Cloud Server was measured at all four time points (Hour 0, 2, 4 and 6)
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Patch Acquisition of IEM to Cloud Server
The information transmission - Patch acquisition of IEM to Cloud Server was measures at all four time points (Hour 0, 2, 4 and 6)
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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
Hour 0
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28 Participants
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—
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—
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—
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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
Hour 2
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27 Participants
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—
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—
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—
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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
Hour 4
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28 Participants
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—
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—
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—
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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
Hour 6
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29 Participants
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—
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—
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—
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PRIMARY outcome
Timeframe: Day 1 Visit at 0, 2, 4 and 6 hoursPopulation: 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.
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.
Outcome measures
| Measure |
MIND1 System IEM Detection (All Enrolled Participants)
n=29 Participants
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).
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MDDS to Otsuka Software Application Registration
The information transmission - MDDS to Otsuka software application registration was measured at all four time points (Hour 0, 2, 4 and 6)
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Otsuka Software Application Registration to Cloud Server
The information transmission - Otsuka software application registration to Cloud Server was measured at all four time points (Hour 0, 2, 4 and 6)
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Patch Acquisition of IEM to Cloud Server
The information transmission - Patch acquisition of IEM to Cloud Server was measures at all four time points (Hour 0, 2, 4 and 6)
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Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch
Hour 0
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1.2 Minutes
Standard Deviation 0.8
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—
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—
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—
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Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch
Hour 2
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1.3 Minutes
Standard Deviation 1.0
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—
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—
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—
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Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch
Hour 4
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1.1 Minutes
Standard Deviation 1.3
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—
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—
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—
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Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch
Hour 6
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1.3 Minutes
Standard Deviation 0.9
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—
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—
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—
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SECONDARY outcome
Timeframe: Day 1 Visit at 0, 2, 4 and 6 hoursPopulation: 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.
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
Outcome measures
| Measure |
MIND1 System IEM Detection (All Enrolled Participants)
n=29 Participants
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).
|
MDDS to Otsuka Software Application Registration
n=29 Participants
The information transmission - MDDS to Otsuka software application registration was measured at all four time points (Hour 0, 2, 4 and 6)
|
Otsuka Software Application Registration to Cloud Server
n=29 Participants
The information transmission - Otsuka software application registration to Cloud Server was measured at all four time points (Hour 0, 2, 4 and 6)
|
Patch Acquisition of IEM to Cloud Server
n=29 Participants
The information transmission - Patch acquisition of IEM to Cloud Server was measures at all four time points (Hour 0, 2, 4 and 6)
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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).
Hour 0
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5.59 Minutes
Standard Deviation 23.07
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1.85 Minutes
Standard Deviation 6.38
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0.01 Minutes
Standard Deviation 0.01
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7.46 Minutes
Standard Deviation 23.67
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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).
Hour 2
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9.74 Minutes
Standard Deviation 21.16
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0.52 Minutes
Standard Deviation 0.70
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0.02 Minutes
Standard Deviation 0.01
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10.28 Minutes
Standard Deviation 20.93
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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).
Hour 4
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3.58 Minutes
Standard Deviation 7.84
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2.62 Minutes
Standard Deviation 7.48
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0.01 Minutes
Standard Deviation 0.01
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6.21 Minutes
Standard Deviation 10.36
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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).
Hour 6
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4.00 Minutes
Standard Deviation 7.14
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2.21 Minutes
Standard Deviation 6.60
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0.01 Minutes
Standard Deviation 0.01
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6.21 Minutes
Standard Deviation 8.91
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SECONDARY outcome
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)Population: 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.
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.
Outcome measures
| Measure |
MIND1 System IEM Detection (All Enrolled Participants)
n=29 Participants
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).
|
MDDS to Otsuka Software Application Registration
The information transmission - MDDS to Otsuka software application registration was measured at all four time points (Hour 0, 2, 4 and 6)
|
Otsuka Software Application Registration to Cloud Server
The information transmission - Otsuka software application registration to Cloud Server was measured at all four time points (Hour 0, 2, 4 and 6)
|
Patch Acquisition of IEM to Cloud Server
The information transmission - Patch acquisition of IEM to Cloud Server was measures at all four time points (Hour 0, 2, 4 and 6)
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Number of Participants With AEs Due Study Treatment and MIND1 System
Treatment-Emergent Serious AEs
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0 participants
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—
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—
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—
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Number of Participants With AEs Due Study Treatment and MIND1 System
Serious Related TEAEs
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0 participants
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—
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—
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—
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Number of Participants With AEs Due Study Treatment and MIND1 System
TEAEs led to discontinuation
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0 participants
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—
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—
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—
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Number of Participants With AEs Due Study Treatment and MIND1 System
Number of death
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0 participants
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—
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—
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—
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Number of Participants With AEs Due Study Treatment and MIND1 System
All Treatment-Emergent Adverse Events (TEAEs)
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0 participants
|
—
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—
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—
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Adverse Events
MIND1 System IEM Detection (All Enrolled Participants)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tim Peters-Strickland
Otsuka Pharmaceutical Development & Commercialization, Inc
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place