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NCT02091882 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Completed
Registry status
Phase 4
Development phase
30
Enrollment target

NCT02091882: Completed Phase 4 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT02091882 is a Phase 4 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02091882, a Phase 4 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.

COMPLETED
Registry status
Phase 4
Development phase
30 participants
Enrollment target

Study 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.

Primary Outcome

The accuracy of IEM signal detection was collected by comparing the time of ingestion recorded by MIND1 system at different timepoints with the time recorded by the clinic staff. The percentage of participants with the accurate time of IEM detection are reported for each ingestion separately at Hours 0, 2, 4 and 6 on Day 1.

Interventions

  • DRUG Placebo
  • COMBINATION_PRODUCT Combination product of Aripiprazole + IEM + Sensor + MIND1 Application

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2014-03-21
Est. Completion 2014-04-18
Phase Phase 4

What the finished NCT02091882 record still lists

NCT02091882 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02091882 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02091882 about?

NCT02091882 is a clinical study titled "Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)". 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.

What is the current status of trial NCT02091882?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2014-03-21. Estimated completion is 2014-04-18.

What interventions are being tested in trial NCT02091882?

The interventions under investigation include: Placebo (DRUG), Combination product of Aripiprazole + IEM + Sensor + MIND1 Application (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT02091882?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02091882's enrollment target sits among peer trials

30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02091882, the US trial registry maintained by the National Library of Medicine. NCT02091882 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.