Phase 4
Completed N=29
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
Device Latency
Source: ClinicalTrials.gov NCT02404532 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: 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 — 28; 27; 28; 29 Participants
◆ Published Evidence
Emerging
2citations · ~1 / year
Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials.
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.
Linked Publications
-
Safety Evaluation in Iterative Development of Wearable Patches for Aripiprazole Tablets With Sensor: Pooled Analysis of Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
28; 27; 28; 29 | — |
| PRIMARY Latency Period Between the Clinical Site-reported Ingestion Time and the Signal Detection of the Ingestion Event by the Patch |
1.2; 1.3; 1.1; 1.3 | — |
| SECONDARY 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). |
5.59; 1.85; 0.01; 7.46; 9.74; 0.52 | — |
| SECONDARY Number of Participants With AEs Due Study Treatment and MIND1 System |
0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT02404532) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.