NCT02091882

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

OSMITTER 316-13-206A 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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

The OSMITTER study protocol was designed as a master protocol governing multiple substudies for the rapid assessment of candidate subcomponents for the MIND1 System. This substudy was 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.

Conditions

• Device Latency

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-03-21
• Primary completion: 2014-04-18
• Completion: 2014-04-18
• First posted: 2014-03-19
• Last updated: 2021-10-26
• Results posted: 2021-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study