ThromboembolismNCT03424330
Evaluation of ReX-C System in Measurement and Improvement of Patients' Adherence.
A study testing ReX-C intervention in people with Thromboembolism, run by Dosentrx Ltd. at 1 site in Israel.
Trial summary
The study aims to evaluate the safety, usability and efficacy of the ReX-C - a novel medication management system - in measurement and improvement of adherence, in patients receiving oral anti-coagulation therapy for the treatment and prevention of thromboembolism. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboembolism
- What is being tested?
- ReX-C intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Jan 2019to 25 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, at least 18 years of age
- Subject is able to swallow pills and use ReX-C device to receive medication.
- Subject is able to read and understand the Informed Consent Form.
- Subject receives anti-coagulants for the treatment and prevention of thromboembolism events, (e.g: Arterial Fibrillation (AF), Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)).
- Subject receives Novel Oral Anti-coagulant (NOAC); including; Pradaxa® (dabigatran), Xarelto® (rivaroxaban) and Eliquis® (apixaban).
- Subject is recruited at least 1 month after treatment initiation and has stable dose regime.
- Subject receives stable dose of medication for at least a month.
- Subject takes medication therapy at home.
Who cannot join
- Subject has significant physical disability including; poor fine motor skills, impaired visual or auditory faculties, mental disorders or other impairment affecting ability to provide Informed Consent Form or use the ReX-C dispensing unit effectively.
- Subject cen not use ReX-C to receive medications.
- Subject is participating in another clinical study that does not permit participation in two studies simultaneously.
- Subject is at end stage or terminal illness with anticipated life expectancy of 6 months or less.
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Carmel Medical Center
Haifa, 3436212
Meir Preis, MD, MeirPr@clalit.org.il
About this study
Official title: Evaluation of ReX-C System in Measurement and Improvement of Adherence, in Patients Receiving Oral Anti-coagulation Therapy for the Treatment and Prevention of Thromboembolism.
The study aims to evaluate the safety, usability and efficacy of the ReX-C - a novel medication management system - in measurement and improvement of adherence, in patients receiving oral anti-coagulation therapy for the treatment and prevention of thromboembolism.
Read the detailed description
ReX-C is a mobile system intended to provide solid, oral medication on patient demand, according to a pre-programmed treatment protocol. ReX-C addresses poor adherence to medication therapy by providing real-time, reliable adherence data to caregivers and timely, personalized reminders to patients.
During the study, the use of ReX-C system to receive medications will be compared to Standard of Care. Patients' adherence will be evaluated for both methods.
- Conditions
- Thromboembolism
- Being tested
- ReX-C intervention, Standard of Care
- Medical subject headings
- Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReX-C interventionDevice
Patients receive medication by the ReX-C device
Standard of CareOther
Patients receive medication as usual
| Study group | Role | What they receive |
|---|---|---|
| Arm1 - ReX first | Experimental | Subjects begin with the ReX-C Intervention stage followed by Standard of Care stage. Receives: Device: ReX-C intervention; Other: Standard of Care |
| Arm 2- Standard of Care first | Experimental | Subjects start with Standard of Care stage followed by ReX-C Intervention. Receives: Device: ReX-C intervention; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of ReX- C system, measured by incidences of pill overdose, pills malformation and adverse events related to the device use.
incidences of pill overdose, pills malformation and adverse events related to the device use will be measured by a questionnaire.
Measured: 18 weeks
Ease of use and acceptance of ReX-C system measured by a questionnaire
Patients will be asked about their experience with ReX-C.
Measured: 18 weeks
ReX-C capability to assess patient's adherence, measured by ReX-C record of missed/ delayed dose.
Any event of delayed pill intake recorded by ReX-C should lead to a personal reminder to patient, who has to confirm the delay and act to take the missing dose.
Measured: 18 weeks
Secondary outcomes (1)
Adherence rate measured by patient's plasma drug level
A comparison of adherence rate, measured by patient's plasma drug level, between ReX intervention stage and Standard of Care stage
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start9 Jan 2019
- Primary completion25 Dec 2023 (estimated)
- Study completion25 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study will employ a randomized, controlled crossover study design. The study comprises two stages: * Stage 1: ReX-C Intervention in which subjects will use ReX-C to receive medication. * Stage 2: Control, in which Treatment as Usual (TAU). All subjects enrolled for the study will participate in both stages in a randomized crossover mode.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dosentrx Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meir Preis, MD, Principal investigator, Carmel Medical Center, Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424330
- Sponsor's protocol ID
- RXC-154-2017-CLE
- Status last verified
- Dec 2023
- First submitted
- 15 Jan 2018
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ReX-C System in Measurement and Improvement of Adherence, in Patients Receiving Oral Anti-coagulation Therapy for the Treatment and Prevention of Thromboembolism.
- ClinicalTrials.gov ID
- NCT03424330
- Acronym / sponsor ID
- RXC-154-2017-CLE
- Conditions
- Thromboembolism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Dosentrx Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jan 2019 (actual)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 25 Dec 2023 (estimated)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aims to evaluate the safety, usability and efficacy of the ReX-C - a novel medication management system - in measurement and improvement of adherence, in patients receiving oral anti-coagulation therapy for the treatment and prevention of thromboembolism.
Detailed description
ReX-C is a mobile system intended to provide solid, oral medication on patient demand, according to a pre-programmed treatment protocol. ReX-C addresses poor adherence to medication therapy by providing real-time, reliable adherence data to caregivers and timely, personalized reminders to patients.
During the study, the use of ReX-C system to receive medications will be compared to Standard of Care. Patients' adherence will be evaluated for both methods.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will employ a randomized, controlled crossover study design. The study comprises two stages: * Stage 1: ReX-C Intervention in which subjects will use ReX-C to receive medication. * Stage 2: Control, in which Treatment as Usual (TAU). All subjects enrolled for the study will participate in both stages in a randomized crossover mode.
| Arm | Type | Receives |
|---|---|---|
| Arm1 - ReX first | Experimental | Device: ReX-C intervention, Other: Standard of CareSubjects begin with the ReX-C Intervention stage followed by Standard of Care stage. |
| Arm 2- Standard of Care first | Experimental | Device: ReX-C intervention, Other: Standard of CareSubjects start with Standard of Care stage followed by ReX-C Intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or Female, at least 18 years of age
- Subject is able to swallow pills and use ReX-C device to receive medication.
- Subject is able to read and understand the Informed Consent Form.
- Subject receives anti-coagulants for the treatment and prevention of thromboembolism events, (e.g: Arterial Fibrillation (AF), Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)).
- Subject receives Novel Oral Anti-coagulant (NOAC); including; Pradaxa® (dabigatran), Xarelto® (rivaroxaban) and Eliquis® (apixaban).
Key exclusion criteria (5 listed)
- Subject has significant physical disability including; poor fine motor skills, impaired visual or auditory faculties, mental disorders or other impairment affecting ability to provide Informed Consent Form or use the ReX-C dispensing unit effectively.
- Subject cen not use ReX-C to receive medications.
- Subject is participating in another clinical study that does not permit participation in two studies simultaneously.
- Subject is at end stage or terminal illness with anticipated life expectancy of 6 months or less.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReX-C interventionPatients receive medication by the ReX-C device | Device | Arm 2- Standard of Care first, Arm1 - ReX first |
| Standard of CarePatients receive medication as usual | Other | Arm 2- Standard of Care first, Arm1 - ReX first |
Primary outcome
Safety of ReX- C system, measured by incidences of pill overdose, pills malformation and adverse events related to the device use.
Time frame: 18 weeks
incidences of pill overdose, pills malformation and adverse events related to the device use will be measured by a questionnaire.
Ease of use and acceptance of ReX-C system measured by a questionnaire
Time frame: 18 weeks
Patients will be asked about their experience with ReX-C.
ReX-C capability to assess patient's adherence, measured by ReX-C record of missed/ delayed dose.
Time frame: 18 weeks
Any event of delayed pill intake recorded by ReX-C should lead to a personal reminder to patient, who has to confirm the delay and act to take the missing dose.
1 secondary outcome
Adherence rate measured by patient's plasma drug level
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meir Preis, MD principal investigator
Carmel Medical Center, Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReX-C intervention in people with Thromboembolism, run by Dosentrx Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronit Shtrichman, Ph.D (972526500938, ronit.s@dosentrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of ReX- C system, measured by incidences of pill overdose, pills malformation and adverse events related to the device use. (time frame: 18 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.