Any Solid Oral MedicationRegStudNCT06335758
Non-randomized Observational Study to Evaluate ReX® in the Management of Solid Oral Medication.
An observational study of Any Solid Oral Medication, run by Dosentrx Ltd. at 1 site in United States.
Trial summary
The goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication. The study will evaluate and monitor use of ReX in respect of: treatment duration adverse events patient adherence and compliance engagement… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Any Solid Oral Medication
- What is being tested?
- Use of ReX to dispense and monitor solid oral medication therapy.
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to 31 Jan 2026
- Phase
- Observational
- 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
Study population: Patients who receive treatment with solid oral medication as a standard of care within ReX.
Who may be able to join
- 18 years of age or older.
- Care team recommends the use of ReX as a standard of care.
- Patients have 5th grade reading level.
- Patient was prescribed oral medication.
- Patient takes medication at home.
Who cannot join
- Patient 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 or use the ReX dispensing unit effectively.
- Patient failed to pass the learning module during ReX onboarding flow.
- Patient 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.
United States1 site, 1 recruiting
- Recruiting
OHC
Cincinnati, Ohio, 45242
Zachary Beck
About this study
Official title: Non-randomized Observational Study to Collate Data Regarding the Safety, Efficacy and Satisfaction of ReX® in the Management of Solid Oral Medications.
The goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication.
The study will evaluate and monitor use of ReX in respect of:
- treatment duration
- adverse events
- patient adherence and compliance
- engagement with ReX via patient-reported outcomes
Patients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen.
Read the detailed description
The ReX platform is a class 1 FDA device listed under product code NXB Dispenser Solid Medication. It comprises:
- Hand-held medication dispenser with touch screen (ReX Remote Digital Nurse).
- Disposable cartridge pre-loaded with pills or capsules. The cartridge includes an integral mouthpiece. Patients inhale at the mouthpiece causing pills to be dispensed into the mouth.
- Web application (ReX Treatment Manager) which collects data generated by the ReX hand-held dispenser.
ReX manages and monitors medication-based therapy by means of:
- Reminders to take pills. Reminders are sent to patients and caregivers by email, SMS or via the telephone support team.
- Electronic patient recorded outcomes (ePROs) presented to patients via the dispenser touch screen. ePROs include questions, tips and reminders.
- Notifications sent by email or SMS in the event of the patient exceeding a pre-defined threshold.
In this study, following training, patients will be offered their standard oral medication via the ReX Remote Digital Nurse. They will receive cartridges pre-loaded with medication by the pharmacy. Safety, efficacy and patient satisfaction with the device are monitored over a 24-week period by phone calls and periodic questionnaires.
Data collected by the ReX Remote Digital Nurse include:
- medication name
- prescribed dosage
- doses taken per day
- pills taken per dose
- ePRO responses
- missed pill intakes
- Conditions
- Any Solid Oral Medication
- Being tested
- Use of ReX to dispense and monitor solid oral medication therapy.
- Keywords
- Solid oral medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of ReX to dispense and monitor solid oral medication therapy.Device
ReX Remote Digital Nurse comprising hand-held dispenser, disposable drug cartridge and web application (ReX Treatment Manager).
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving solid oral medication as a standard of care. | Solid oral medication administered via the ReX Remote Digital Nurse. Receives: Device: Use of ReX to dispense and monitor solid oral medication therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment duration
At least 3 months while using ReX
Measured: 24 weeks
Patient satisfaction
At least 3.5 on a scale up to 5
Measured: 24 weeks
Adverse events
None related to use of ReX
Measured: 24 weeks
Patient adherence
No. of pills taken by patient as a percentage of pills prescribed >80%
Measured: 24 weeks
Patient compliance
No. of pills taken as percentage of pills to be taken in alloted time frame >70%
Measured: 24 weeks
Patient engagement
No. of questions answered as a percentage of questions asked >70% of ePROs
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start15 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Any Solid Oral MedicationStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dosentrx Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- US Oncology Research
- Responsible party
- Sponsor
- Investigators
- David Waterhouse, MD, Principal investigator, US Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335758
- Sponsor's protocol ID
- EXC-039-2023-CLR
- Acronym
- RegStud
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 28 Mar 2024
- 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 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-randomized Observational Study to Collate Data Regarding the Safety, Efficacy and Satisfaction of ReX® in the Management of Solid Oral Medications.
- ClinicalTrials.gov ID
- NCT06335758
- Acronym / sponsor ID
- RegStud / EXC-039-2023-CLR
- Conditions
- Any Solid Oral Medication
- Keywords
- Solid oral medication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Dosentrx Ltd.Industry (pharma, biotech, devices)
- Collaborators
- US Oncology Research
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 28 Mar 2024 (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 goal of this observational study is to evaluate the safety, efficacy and patient satisfaction with the ReX Remote Digital Nurse by patients receiving solid oral medication.
The study will evaluate and monitor use of ReX in respect of:
- treatment duration
- adverse events
- patient adherence and compliance
- engagement with ReX via patient-reported outcomes
Patients participating in the study will receive their normal medication as standard of care via ReX. Progress will be monitored via patients' responses to questions presented on the ReX touch screen.
Detailed description
The ReX platform is a class 1 FDA device listed under product code NXB Dispenser Solid Medication. It comprises:
- Hand-held medication dispenser with touch screen (ReX Remote Digital Nurse).
- Disposable cartridge pre-loaded with pills or capsules. The cartridge includes an integral mouthpiece. Patients inhale at the mouthpiece causing pills to be dispensed into the mouth.
- Web application (ReX Treatment Manager) which collects data generated by the ReX hand-held dispenser.
ReX manages and monitors medication-based therapy by means of:
- Reminders to take pills. Reminders are sent to patients and caregivers by email, SMS or via the telephone support team.
- Electronic patient recorded outcomes (ePROs) presented to patients via the dispenser touch screen. ePROs include questions, tips and reminders.
- Notifications sent by email or SMS in the event of the patient exceeding a pre-defined threshold.
In this study, following training, patients will be offered their standard oral medication via the ReX Remote Digital Nurse. They will receive cartridges pre-loaded with medication by the pharmacy. Safety, efficacy and patient satisfaction with the device are monitored over a 24-week period by phone calls and periodic questionnaires.
Data collected by the ReX Remote Digital Nurse include:
- medication name
- prescribed dosage
- doses taken per day
- pills taken per dose
- ePRO responses
- missed pill intakes
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients receiving solid oral medication as a standard of care. | – | Device: Use of ReX to dispense and monitor solid oral medication therapy.Solid oral medication administered via the ReX Remote Digital Nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who receive treatment with solid oral medication as a standard of care within ReX.
Key inclusion criteria (5 listed)
- 18 years of age or older.
- Care team recommends the use of ReX as a standard of care.
- Patients have 5th grade reading level.
- Patient was prescribed oral medication.
- Patient takes medication at home.
Key exclusion criteria (3 listed)
- Patient 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 or use the ReX dispensing unit effectively.
- Patient failed to pass the learning module during ReX onboarding flow.
- Patient 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 |
|---|---|---|
| Use of ReX to dispense and monitor solid oral medication therapy.ReX Remote Digital Nurse comprising hand-held dispenser, disposable drug cartridge and web application (ReX Treatment Manager). | Device | Patients receiving solid oral medication as a standard of care. |
Primary outcome
Treatment duration
Time frame: 24 weeks
At least 3 months while using ReX
Patient satisfaction
Time frame: 24 weeks
At least 3.5 on a scale up to 5
Adverse events
Time frame: 24 weeks
None related to use of ReX
Patient adherence
Time frame: 24 weeks
No. of pills taken by patient as a percentage of pills prescribed >80%
Patient compliance
Time frame: 24 weeks
No. of pills taken as percentage of pills to be taken in alloted time frame >70%
Patient engagement
Time frame: 24 weeks
No. of questions answered as a percentage of questions asked >70% of ePROs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Website of ReX Remote Digital NurseLink provided by the sponsor.
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.
David Waterhouse, MD principal investigator
US Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Any Solid Oral Medication, run by Dosentrx Ltd. at 1 site in United States.
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 5 inclusion and 3 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 28 Mar 2024. 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 United States. 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 Natan Paz (+972 52 6577126, natan.p@dosentrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment duration (time frame: 24 weeks). The study lists 6 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 28 Mar 2024.