Pain, PostoperativeNCT03134001
Evaluation of Oral PCA Device - PCoA™ Acute
A study testing patients receiving oral analgesics via the PCoA™ Acute in people with Pain, Postoperative, run by Dosentrx Ltd..
Trial summary
Randomized, open label, controlled pilot clinical study comprised hospitalized post operative patients receiving oral analgesics. The study aims to evaluate the safety, efficacy and usability of a novel pill dispensing system - PCoA™ Acute and compare it to the conventional procedure of nurse providing analgesics. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- patients receiving oral analgesics via the PCoA™ Acute
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2015to 30 Nov 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Operative procedure with at least 3 days' hospital stay.
- Planned post-operative pain therapy with oral medication using a strong opioid.
- No contra-indication for opioid therapy.
- No contra-indication for oral pain therapy.
- Patient was able to understand and complete the questionnaire.
- Patient signed an informed consent form.
Who cannot join
- 1. Opioid or drug addiction. 2. Opioid intolerance. 3. Pain therapy using IV PCA or infusion. 4. Rejection of opioid therapy. 5. Not able to swallow medicine.
- -
About this study
Official title: Evaluation of Oral Patient-Controlled Analgesia (PCA) Device - PCoA™ Acute , for Hospitalized Patients With Post-operative Pain
Randomized, open label, controlled pilot clinical study comprised hospitalized post operative patients receiving oral analgesics. The study aims to evaluate the safety, efficacy and usability of a novel pill dispensing system - PCoA™ Acute and compare it to the conventional procedure of nurse providing analgesics.
- Conditions
- Pain, Postoperative
- Being tested
- patients receiving oral analgesics via the PCoA™ Acute
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patients receiving oral analgesics via the PCoA™ AcuteDevice
PCoA™ Acute is an oral PCA device, designed to provide safe and easy-to-use pain medication at the bedside. It identifies patients by Radio Frequency Identification (RFID) technology and provides pill dispensing upon patient's request.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Patients receiving oral analgesics via the PCoA™ Acute device Receives: Device: patients receiving oral analgesics via the PCoA™ Acute |
| Control Group | No intervention | Patients receiving oral analgesics by nurse, upon request |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCoA™ Acute safety
No pill overdose, No pills malformation upon dispensing, No pill inhalation during pill sucking, 4. No adverse events
Measured: 48 hr
PCoA™ Acute efficacy
Success rate of 90% for pill intake upon patient's request, No critical device malfunction, Time of pill intake reduced by at least 50% in the test group compared to the control group
Measured: 48hr
PCoA™ Acute usability
At least 80% of patients and medical staff are satisfied with device use and will recommend its use for their colleagues
Measured: 48hr
Secondary outcomes (1)
Number of pill intakes during the study
Number of pain medications obtained by the patients during the study
Measured: 48hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 Jun 2015
- Primary completion30 Nov 2015
- Study completion30 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Study includes 2 groups: test group comprised patients receiving oral analgesics via the PCoA™ Acute and control group of nurse providing analgesics.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dosentrx Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134001
- Sponsor's protocol ID
- PCoAAcute001
- Status last verified
- Apr 2017
- First submitted
- 25 Apr 2017
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Oral Patient-Controlled Analgesia (PCA) Device - PCoA™ Acute , for Hospitalized Patients With Post-operative Pain
- ClinicalTrials.gov ID
- NCT03134001
- Acronym / sponsor ID
- PCoAAcute001
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Dosentrx Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 30 Nov 2015 (actual)
- Study completion
- 30 Nov 2015 (actual)
- First posted
- 28 Apr 2017 (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.
Randomized, open label, controlled pilot clinical study comprised hospitalized post operative patients receiving oral analgesics. The study aims to evaluate the safety, efficacy and usability of a novel pill dispensing system - PCoA™ Acute and compare it to the conventional procedure of nurse providing analgesics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study includes 2 groups: test group comprised patients receiving oral analgesics via the PCoA™ Acute and control group of nurse providing analgesics.
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: patients receiving oral analgesics via the PCoA™ AcutePatients receiving oral analgesics via the PCoA™ Acute device |
| Control Group | No intervention | –Patients receiving oral analgesics by nurse, upon request |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Operative procedure with at least 3 days' hospital stay.
- Planned post-operative pain therapy with oral medication using a strong opioid.
- No contra-indication for opioid therapy.
- No contra-indication for oral pain therapy.
- Patient was able to understand and complete the questionnaire.
Key exclusion criteria (2 listed)
- 1. Opioid or drug addiction. 2. Opioid intolerance. 3. Pain therapy using IV PCA or infusion. 4. Rejection of opioid therapy. 5. Not able to swallow medicine.
- -
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 |
|---|---|---|
| patients receiving oral analgesics via the PCoA™ AcutePCoA™ Acute is an oral PCA device, designed to provide safe and easy-to-use pain medication at the bedside. It identifies patients by Radio Frequency Identification (RFID) technology and provides pill dispensing upon patient's request. | Device | Test Group |
Primary outcome
PCoA™ Acute safety
Time frame: 48 hr
No pill overdose, No pills malformation upon dispensing, No pill inhalation during pill sucking, 4. No adverse events
PCoA™ Acute efficacy
Time frame: 48hr
Success rate of 90% for pill intake upon patient's request, No critical device malfunction, Time of pill intake reduced by at least 50% in the test group compared to the control group
PCoA™ Acute usability
Time frame: 48hr
At least 80% of patients and medical staff are satisfied with device use and will recommend its use for their colleagues
1 secondary outcome
Number of pill intakes during the study
Time frame: 48hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing patients receiving oral analgesics via the PCoA™ Acute in people with Pain, Postoperative, run by Dosentrx Ltd..
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCoA™ Acute safety (time frame: 48 hr). 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 8 May 2017.