MedTrace Logo

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

NCT02091882 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-10-26

Study results available
· View outcomes & findings →

Summary

The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.

Conditions

  • Device Latency

Interventions

DRUG

Placebo

Oral placebo-embedded IEM tablet.

COMBINATION_PRODUCT

Combination product of Aripiprazole + IEM + Sensor + MIND1 Application

Combination product of aripiprazole tablet embedded with sensor and wearable patch with MIND1 system on smartphone

Sponsors & Collaborators

  • Otsuka Pharmaceutical Development & Commercialization, Inc.

    lead INDUSTRY

Principal Investigators

  • Study Director · Otsuka Pharmaceutical Development & Commercialization

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-21
Primary Completion
2014-04-18
Completion
2014-04-18
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02091882 on ClinicalTrials.gov