Trial Outcomes & Findings for A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion (NCT NCT06372210)

Last Updated: 2024-07-31

Results Overview

The PDA is calculated as the number of total positive detections by patch divided by the number of the total DOIs. PDA was estimated by Clopper-Pearson method.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

At Day 1

Results posted on

2024-07-31

Participant Flow

Participants took part in this study at a single investigative site in the United States from 26 June 2023 to 19 July 2023.

A total of 54 participants were enrolled in this study and all participants completed the study.

Participant milestones

Participant milestones
Measure	Cohort 1: D-Tect Patch + Placebo-embedded IEM A D-Tect patch was applied by the clinical staff prior to the first ingestion of a placebo-embedded ingestible event marker (IEM) tablet. Directly observed ingestions (DOIs) of 15 placebo-embedded IEM tablets were noted at 15-minute intervals on Day 1.	Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) A D-Tect patch was applied by the clinical staff prior to the ingestion of the IEM-embedded Abilify MyCite® tablet. A DOI of a single dose of Abilify MyCite® tablet occurred on Day 1.
Overall Study STARTED	24	30
Overall Study COMPLETED	24	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: D-Tect Patch + Placebo-embedded IEM n=24 Participants A D-Tect patch was applied by the clinical staff prior to the first ingestion of a placebo-embedded IEM tablet. DOIs of 15 placebo-embedded IEM tablets were noted at 15 minute intervals on Day 1.	Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) n=30 Participants A D-Tect patch was applied by the clinical staff prior to the ingestion of the IEM-embedded Abilify MyCite® tablet. A DOI of a single dose of Abilify MyCite® tablet occurred on Day 1.	Total n=54 Participants Total of all reporting groups
Age, Continuous	50.8 years STANDARD_DEVIATION 13.56 • n=5 Participants	46.1 years STANDARD_DEVIATION 12.03 • n=7 Participants	48.2 years STANDARD_DEVIATION 12.82 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	10 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	20 Participants n=7 Participants	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	16 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	14 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	12 Participants n=5 Participants	1 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	6 Participants n=5 Participants	20 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 Participants n=5 Participants	30 Participants n=7 Participants	54 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 1

Population: Full analysis set (FAS) comprised of all the detections of the wearable sensors done on the participants who took at least 1 dose of a miniature ingestible tablet (MIT) (Cohort 1), excluding those detections with device malfunction (invalid session and bad impedance). 'Overall number of participants analyzed' indicates the number of participants with at least one detection in Cohort 1.

The PDA is calculated as the number of total positive detections by patch divided by the number of the total DOIs. PDA was estimated by Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Cohort 1: D-Tect Patch + Placebo-embedded IEM n=358 Number of detections A D-Tect patch was applied by the clinical staff prior to the first ingestion of a placebo-embedded IEM tablet. DOIs of 15 placebo-embedded IEM tablets were noted at 15 minute intervals on Day 1.	Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) A D-Tect patch was applied by the clinical staff prior to the ingestion of the IEM-embedded Abilify MyCite® tablet. A DOI of a single dose of Abilify MyCite® tablet occurred on Day 1.
Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch	100 percentage of detections Interval 98.97 to 100.0	—

PRIMARY outcome

Timeframe: At Day 1

Population: The FAS comprised of all the detections of the wearable sensors done on the participants who took at least 1 dose of MIT (Cohort 1) or Abilify MyCite® (Cohort 2), excluding those detections with device malfunction (invalid session and bad impedance). "Overall number of participants analyzed" indicates the number of participants with at least one detection.

The patch detection latency period is defined as the time between the ingestion of the tablet and the detection of the tablet ingestion by the patch. Kaplan Meier estimation was used to measure the patch detection latency period.

Outcome measures

Outcome measures
Measure	Cohort 1: D-Tect Patch + Placebo-embedded IEM n=358 Number of detections A D-Tect patch was applied by the clinical staff prior to the first ingestion of a placebo-embedded IEM tablet. DOIs of 15 placebo-embedded IEM tablets were noted at 15 minute intervals on Day 1.	Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) n=30 Number of detections A D-Tect patch was applied by the clinical staff prior to the ingestion of the IEM-embedded Abilify MyCite® tablet. A DOI of a single dose of Abilify MyCite® tablet occurred on Day 1.
Cohort 1 and 2: Patch Detection Latency Period	53.0 seconds Interval 11.0 to 206.0	312.0 seconds Interval 90.0 to 695.0

PRIMARY outcome

Timeframe: At Day 1

The ingestion data transfer latency period is measured as the time between the detection of the tablet ingestion by the patch and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the ingestion data transfer latency period.

Outcome measures

Outcome measures
Measure	Cohort 1: D-Tect Patch + Placebo-embedded IEM n=358 Number of detections A D-Tect patch was applied by the clinical staff prior to the first ingestion of a placebo-embedded IEM tablet. DOIs of 15 placebo-embedded IEM tablets were noted at 15 minute intervals on Day 1.	Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) n=30 Number of detections A D-Tect patch was applied by the clinical staff prior to the ingestion of the IEM-embedded Abilify MyCite® tablet. A DOI of a single dose of Abilify MyCite® tablet occurred on Day 1.
Cohort 1 and 2: Ingestion Data Transfer Latency Period	17.0 seconds Interval 0.0 to 536.0	17.0 seconds Interval 6.0 to 145.0

PRIMARY outcome

Timeframe: At Day 1

The total detection latency is measured as the total time between the ingestion of the tablet and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the total detection the latency period.

Outcome measures

Outcome measures
Measure	Cohort 1: D-Tect Patch + Placebo-embedded IEM n=358 Number of detections A D-Tect patch was applied by the clinical staff prior to the first ingestion of a placebo-embedded IEM tablet. DOIs of 15 placebo-embedded IEM tablets were noted at 15 minute intervals on Day 1.	Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) n=30 Number of detections A D-Tect patch was applied by the clinical staff prior to the ingestion of the IEM-embedded Abilify MyCite® tablet. A DOI of a single dose of Abilify MyCite® tablet occurred on Day 1.
Cohort 1 and 2: Total Detection Latency Period	73.0 seconds Interval 11.0 to 587.0	351.0 seconds Interval 107.0 to 729.0

SECONDARY outcome

Timeframe: From Day 1 up to follow-up (up to Day 10)

Population: Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.

TEAEs were defined as AEs that occurred on or after the participant wears any patch or takes any tablet from the study at test day, and the AEs that occurred before the participant wears any patch or takes any tablet and are worsening, serious, related, or resulted in death, discontinuation, or interruption of investigational product. A serious TEAE was defined as a TEAE that is fatal, life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, or requires inpatient hospitalization or prolongation of existing hospitalization.

Outcome measures

Outcome measures
Measure	Cohort 1: D-Tect Patch + Placebo-embedded IEM n=24 Participants A D-Tect patch was applied by the clinical staff prior to the first ingestion of a placebo-embedded IEM tablet. DOIs of 15 placebo-embedded IEM tablets were noted at 15 minute intervals on Day 1.	Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) n=30 Participants A D-Tect patch was applied by the clinical staff prior to the ingestion of the IEM-embedded Abilify MyCite® tablet. A DOI of a single dose of Abilify MyCite® tablet occurred on Day 1.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation Participants With TEAEs	7 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation Participants With Device-related TEAEs	5 Participants	3 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation Participants With Serious TEAEs	0 Participants	0 Participants
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation Participants With TEAEs Leading to Study Discontinuation	0 Participants	0 Participants

Adverse Events

Cohort 1: D-Tect Patch + Placebo-embedded IEM

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1: D-Tect Patch + Placebo-embedded IEM n=24 participants at risk A D-Tect patch was applied by the clinical staff prior to the first ingestion of a placebo-embedded IEM tablet. DOIs of 15 placebo-embedded IEM tablets were noted at 15 minute intervals on Day 1.	Cohort 2: D-Tect Patch + Abilify MyCite® (Aripiprazole-embedded IEM) n=30 participants at risk A D-Tect patch was applied by the clinical staff prior to the ingestion of the IEM-embedded Abilify MyCite® tablet. A DOI of a single dose of Abilify MyCite® tablet occurred on Day 1.
General disorders Medical device site pruritus	16.7% 4/24 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.	6.7% 2/30 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.
General disorders Medical device site erythema	0.00% 0/24 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.	3.3% 1/30 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.
General disorders Medical device site irritation	4.2% 1/24 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.	0.00% 0/30 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.
Gastrointestinal disorders Faeces discoloured	0.00% 0/24 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.	3.3% 1/30 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.
Gastrointestinal disorders Cheilitis	4.2% 1/24 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.	0.00% 0/30 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.
Gastrointestinal disorders Nausea	4.2% 1/24 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.	0.00% 0/30 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.
Nervous system disorders Headache	4.2% 1/24 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.	0.00% 0/30 • From Day 1 up to follow-up (up to Day 10) Safety analysis set included all participants who wore any patch or took any tablet from the study and had any safety assessment.

Additional Information

Global Clinical Development

Otsuka Pharmaceutical Development & Commercialization, Inc.

Phone: 1-609-524-6788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place