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NCT02404532 · ClinicalTrials.gov registry record · Phase 4
Substudy 'B' 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
NCT02404532: Completed Phase 4 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT02404532 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.
The verdict
NCT02404532, 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 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.
Primary Outcome
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
Interventions
- DEVICE MIND1 System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-02 |
| Est. Completion | 2015-03 |
| Phase | Phase 4 |
What the finished NCT02404532 record still lists
NCT02404532 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 1 intervention - of which MIND1 System is the first listed.
NCT02404532 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02404532 about?
NCT02404532 is a clinical study titled "Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)". 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.
What is the current status of trial NCT02404532?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2015-02. Estimated completion is 2015-03.
What interventions are being tested in trial NCT02404532?
The interventions under investigation include: MIND1 System (DEVICE).
Who is sponsoring clinical trial NCT02404532?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02404532'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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