CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
MEMS Cap +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02344251
NCT02344251N/ACompleted

A Phase II Randomized Trial to Assess the Effectiveness and Safety of the ID-Cap System for Medication Ingestion Monitoring and Enhancing Adherence

Medical University of South Carolina·interventional·Posted Jan 22, 2015·Updated Jun 1, 2018

In Brief

A clinical study evaluating MEMS Cap and ID-Cap for Medication Adherence. Completed, enrolled 40 participants across 1 site.

Detailed Summary

In pharmacotherapy trials involving drug-dependent individuals, medication compliance is a significant issue, as rates tend to be low and adherence to medication may predict improved outcomes (Baros et al, 2007; McRae et al, 2004; O'Brien et al, 1996; Somoza et al., 2010). However, methods commonly used to determine compliance may result in inaccurate measurement of adherence. In this study, we propose to assess the effectiveness and safety of the ID-Cap System, a novel compliance measurement device, in a healthy population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 22, 2015
Enrollment StartJun 1, 2016
Primary CompletionDec 7, 2016
Study CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 11.4 years ago

Interventions

MEMS Capdevice

MEMS Track Cap records when the medication bottle is opened and closed

ID-Capdevice

ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.