Device LatencyPhase 4OSMITTERNCT02404532

Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)

A Phase 4 study testing MIND1 System in people with Device Latency, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Device Latency
What is being tested?: MIND1 System
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: Feb 2015to Mar 2015
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
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).
Body mass index between 19 to 32 kg/m2 (inclusive).

Who cannot join

Subject with a history of skin sensitivity to adhesive medical tape or metals.
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.
Subject has received any investigational product within the last 30 days.
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.
Subject has the presence of cognitive impairment.
Subject currently taking antipsychotic medication.

Show all 15Show fewer

Subject with a terminal illness.
Subject with a history of chronic dermatitis.
Subject with a history of gastrointestinal surgery that could impair absorption.
Female subject who is breastfeeding and/or who has a positive serum pregnancy test result prior to receiving trial medications.
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.
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.
No permanent physical residence.
A diastolic blood pressure reading >95 mm Hg or symptomatic hypotension.
Any subject who, in the opinion of the investigator, should not participate in the trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

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.

Placebo-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.

Conditions: Device Latency
Being tested: MIND1 System
Keywords: OPC-14597 Digital, Aripiprazole, Medical Information Device #1 System (MIND1), Ingestible Event Marker

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MIND1 SystemDevice
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).

Study groups in NCT02404532
Study group	Role	What they receive
1	Experimental	Not described Receives: Device: MIND1 System

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.
Measured: Day 1 Visit, at hours 0, 2, 4, 6
Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch
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.
Measured: Day 1 Visit at 0, 2, 4 and 6 hours

Secondary outcomes (2)

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).
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
Measured: Day 1 Visit at 0, 2, 4 and 6 hours
Number of Participants With AEs Due Study Treatment and MIND1 System
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.
Measured: At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2015Mar 2015

First posted31 Mar 2015 (estimated)
Study startFeb 2015
Primary completionFeb 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Device LatencyStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02404532
Sponsor's protocol ID: 316-13-206B
Acronym: OSMITTER
Status last verified: Aug 2018
First submitted: 5 Mar 2015
Last updated: 3 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

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.
PubMed 38085556

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02404532
Acronym / sponsor ID: OSMITTER / 316-13-206B
Conditions: Device Latency
Keywords: OPC-14597 Digital, Aripiprazole, Medical Information Device #1 System (MIND1), Ingestible Event Marker
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
Study start: Feb 2015
Primary completion: Feb 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 31 Mar 2015 (estimated)
Results: Posted 3 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Device: MIND1 System

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.
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).
Body mass index between 19 to 32 kg/m2 (inclusive).

Key exclusion criteria (15 listed)

Subject with a history of skin sensitivity to adhesive medical tape or metals.
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.
Subject has received any investigational product within the last 30 days.
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.
Subject has the presence of cognitive impairment.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MIND1 SystemFollowing 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).	Device	1

Primary outcome

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
Time frame: Day 1 Visit, at hours 0, 2, 4, 6
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.
Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch
Time frame: Day 1 Visit at 0, 2, 4 and 6 hours
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.

2 secondary outcomes

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).
Time frame: Day 1 Visit at 0, 2, 4 and 6 hours
Number of Participants With AEs Due Study Treatment and MIND1 System
Time frame: At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit)

Results and safety

Results posted to the registry on 3 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MIND1 System IEM Detection (All Enrolled Participants)	29	29

Primary outcome: 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

Time frame: Day 1 Visit, at hours 0, 2, 4, 6. Count of participants. Unit: Participants

Measure	MIND1 System IEM Detection (All Enrolled Participants) n = 29
Hour 0	28
Hour 2	27
Hour 4	28
Hour 6	29

Population analysed: 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.

Primary outcome: Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch

Time frame: Day 1 Visit at 0, 2, 4 and 6 hours. Mean (Standard Deviation). Unit: Minutes

Measure	MIND1 System IEM Detection (All Enrolled Participants) n = 29
Hour 0	1.2 (0.8)
Hour 2	1.3 (1.0)
Hour 4	1.1 (1.3)
Hour 6	1.3 (0.9)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: At screening visit (Day -14 to 0), Visit 1 (Day 1) and safety Follow-up (Day 7 [+1] days after the last trial visit). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MIND1 System IEM Detection (All Enrolled Participants)	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Limitations and caveats (from the sponsor): None reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38085556Jan 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Timothy Peters-Strickland, MD study director

Otsuka Pharmaceutical Development & Commercialization, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MIND1 System in people with Device Latency, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Day 1 Visit, at hours 0, 2, 4, 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02404532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.