Pain, AcutePhase 4ADVANCE-EDNCT03868436
PENTHROX™ in the Canadian Emergency Department (ED)
A Phase 4 study testing Methoxyflurane 3mL in people with Pain, Acute, run by Purdue Pharma, Canada at 6 sites in Canada.
Trial summary
This Canadian, multi-centre, prospective, real world study is designed to evaluate the effectiveness of low dose methoxyflurane (MEOF) (PENTHROX™) for the treatment of moderate to severe pain associated with trauma in the Canadian ED. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute
- What is being tested?
- Methoxyflurane 3mL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 6 sitesCanada
- Study dates
- 8 Apr 2019to 8 Sep 2020
- Phase
- Phase 4
- 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
- Conscious adult patients: ≥ 18 years of age
- Moderate to severe pain associated with trauma (NRS0-10 ≥ 4) which is unlikely to require surgery/hospitalization, such as
- Musculoskeletal injuries and physical wounds
- Fractures
- Lacerations
- Burns
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- Dislocations
- Contusions
- Injury due to foreign bodies
- Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent
- Patient is able to follow all study requirements and procedures and complete required questionnaires
Who cannot join
- Multi-level trauma
- Women of child bearing potential who are pregnant or peri partum, including labour
- An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
- Clinically significant renal impairment
- A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
- Hypersensitivity to MEOF or other halogenated anesthetics, or to butylated hydroxytoluene
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- Known or genetically susceptible to malignant hyperthermia or a history of severe adverse reactions in either patient or relatives
- Exacerbation of an underlying condition (i.e., chronic pain)
- Clinically evident or potential hemodynamic instability as per the opinion of the investigator
- Clinically evident respiratory impairment as per the opinion of the investigator
- Prior treatment with PENTHROX within 3 months
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Canada6 sites
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Centre Integre Universitaire De Sante Et De Service Sociaux (CIUSSS) Saguenay-Lac-Saint Jean
Chicoutimi, Quebec, G7H 7K9
Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
Greenfield Park, Quebec, J4V 2H1
Charles V Keating Emergency and Trauma Centre, QEII
Halifax, Nova Scotia, B3H3A7
Markham Stouffville
Markham, Ontario, L3P 7P3
St. Joseph's Healthcare
Welland, Ontario, L3B4W6
About this study
Official title: A Phase IV Real World Study on the Use of Low Dose Methoxyflurane (PENTHROX™) for the Treatment of Moderate to Severe Trauma Pain in the Canadian Emergency Department
This Canadian, multi-centre, prospective, real world study is designed to evaluate the effectiveness of low dose methoxyflurane (MEOF) (PENTHROX™) for the treatment of moderate to severe pain associated with trauma in the Canadian ED.
Read the detailed description
The study will assess the change in pain intensity over 20 minutes from start of administration of PENTHROX™ and will generate Real World Evidence in support of existing clinical trial data including effectiveness, safety and additional parameters of low dose MEOF (PENTHROX™) in Canadian EDs.
- Conditions
- Pain, Acute
- Being tested
- Methoxyflurane 3mL
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methoxyflurane 3mLDrug
Also called PENTHROX™
As soon as possible following enrollment and initial procedures, the patient will be supplied with a PENTHROX™ kit which includes one inhaler containing 3 mL of MEOF for pain management. A member of the research team will train the patient to self-administer MEOF. PENTHROX™ is an approved (trademarked) product in Canada and is commercially available in a combination blister pack with one 3 mL sealed bottle and one PENTHROX™ inhaler with the Activated Carbon (AC) chamber.
| Study group | Role | What they receive |
|---|---|---|
| Methoxyflurane (MEOF)-active treatment | Other | single arm study all subjects will be treated with Methoxyflurane 3 mL Receives: Drug: Methoxyflurane 3mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean pain intensity: Numerical Rating Scale
The level of pain intensity will be collected by means of the Numerical Rating Scale (NRS). The NRS is considered a reliable and valid scale for assessing pain intensity and is preferred by patients for its simplicity. In this 11-point scale, the end points are the extremes of no pain and pain as bad as it could be, or worst pain (i.e. a score of 0 = no pain and a score of 10 = worst pain possible).
Assessed by the patient 20 mins post PENTHROX™ inhalation
Measured: 20 mins from start of administration (STA) of PENTHROX™
Secondary outcomes (5)
Speed of action of analgesia
Speed of action of analgesia is defined as the time at which the patient experiences meaningful pain relief following inhalation of PENTHROX™.
The healthcare professional will instruct the patient to note the time at which they experience meaningful pain relief. The time point will be recorded in the case report form.
Measured: At any point from STA of PENTHROX™ to 20 mins post inhalation
Proportion of treatment-emergent adverse events (TEAEs)
Assessment of patient reported adverse events throughout the observation period.
Measured: At any point From STA of PENTHROX™ until the end of the observation period (24 hours)
Global Medication Performance (GMP) before discharge from ED (Patient & Health Care Professional)
Global medication performance (GMP) is an assessment of the health care professional's and patient's impression of how well a medication works.
Global Medication Performance (GMP)-is a patient and health care provider reported outcome with the objective of assessing the health care professional's and patient's impression of how well a medication works.
GMP is measured by asking the patient and health care professional a single question: "rate the pain relief provided by PENTHROX™" utilizing a 5-point Likert scale where 1=Poor- 5=Excellent
Measured: at 20 minutes From STA of PENTHROX™ and at the end of the observation period (up to 24hours)
Fulfillment of pain relief expectations (Patient & Healthcare professional)
Fulfillment of pain relief expectations- is a patient and health care professional reported outcome with the objective of assessing the health care professional's and patient's impression of how well a medication fulfilled their expectations.
Fulfillment of pain relief expectations is measured by asking the patient and health care professional a single question: "To what extent has your expectations regarding pain control been met" and utilizing a 5-point Likert scale where 1=Poor- 5=Excellent.
Measured: At the end of the observation period (up to 24hours)
Use of rescue medication
The time of first use of rescue medication after STA of PENTHROX™ up to and including 60 minutes will be documented.
Measured: From STA of PENTHROX™ to the end of the observation period (up to 24hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start8 Apr 2019
- Primary completion30 Mar 2020
- Study completion8 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Purdue Pharma, Canada
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sonja Dhani, PhD, Study director, Purdue Pharma, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868436
- Sponsor's protocol ID
- CAN-MEOF-MA-OO1
- Acronym
- ADVANCE-ED
- Status last verified
- Sep 2021
- First submitted
- 21 Feb 2019
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Real World Study on the Use of Low Dose Methoxyflurane (PENTHROX™) for the Treatment of Moderate to Severe Trauma Pain in the Canadian Emergency Department
- ClinicalTrials.gov ID
- NCT03868436
- Acronym / sponsor ID
- ADVANCE-ED / CAN-MEOF-MA-OO1
- Conditions
- Pain, Acute
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Purdue Pharma, CanadaIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 8 Sep 2020 (actual)
- First posted
- 11 Mar 2019 (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.
This Canadian, multi-centre, prospective, real world study is designed to evaluate the effectiveness of low dose methoxyflurane (MEOF) (PENTHROX™) for the treatment of moderate to severe pain associated with trauma in the Canadian ED.
Detailed description
The study will assess the change in pain intensity over 20 minutes from start of administration of PENTHROX™ and will generate Real World Evidence in support of existing clinical trial data including effectiveness, safety and additional parameters of low dose MEOF (PENTHROX™) in Canadian EDs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methoxyflurane (MEOF)-active treatment | Other | Drug: Methoxyflurane 3mLsingle arm study all subjects will be treated with Methoxyflurane 3 mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Conscious adult patients: ≥ 18 years of age
- Moderate to severe pain associated with trauma (NRS0-10 ≥ 4) which is unlikely to require surgery/hospitalization, such as
- Patient (and/or patient's authorized legal representative) should understand the nature of the study and provide written informed consent
- Patient is able to follow all study requirements and procedures and complete required questionnaires
Key exclusion criteria (11 listed)
- Multi-level trauma
- Women of child bearing potential who are pregnant or peri partum, including labour
- An altered level of consciousness, due to any cause, including head injury, drugs, or alcohol
- Clinically significant renal impairment
- A history of liver dysfunction after previous MEOF use or other halogenated anesthetics
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 |
|---|---|---|
| Methoxyflurane 3mLAlso: PENTHROX™As soon as possible following enrollment and initial procedures, the patient will be supplied with a PENTHROX™ kit which includes one inhaler containing 3 mL of MEOF for pain management. A member of the research team will train the patient to self-administer MEOF. PENTHROX™ is an approved (trademarked) product in Canada and is commercially available in a combination blister pack with one 3 mL sealed bottle and one PENTHROX™ inhaler with the Activated Carbon (AC) chamber. | Drug | Methoxyflurane (MEOF)-active treatment |
Primary outcome
Change in mean pain intensity: Numerical Rating Scale
Time frame: 20 mins from start of administration (STA) of PENTHROX™
The level of pain intensity will be collected by means of the Numerical Rating Scale (NRS). The NRS is considered a reliable and valid scale for assessing pain intensity and is preferred by patients for its simplicity. In this 11-point scale, the end points are the extremes of no pain and pain as bad as it could be, or worst pain (i.e. a score of 0 = no pain and a score of 10 = worst pain possible). Assessed by the patient 20 mins post PENTHROX™ inhalation
5 secondary outcomes
Speed of action of analgesia
Time frame: At any point from STA of PENTHROX™ to 20 mins post inhalation
Proportion of treatment-emergent adverse events (TEAEs)
Time frame: At any point From STA of PENTHROX™ until the end of the observation period (24 hours)
Global Medication Performance (GMP) before discharge from ED (Patient & Health Care Professional)
Time frame: at 20 minutes From STA of PENTHROX™ and at the end of the observation period (up to 24hours)
Fulfillment of pain relief expectations (Patient & Healthcare professional)
Time frame: At the end of the observation period (up to 24hours)
Use of rescue medication
Time frame: From STA of PENTHROX™ to the end of the observation period (up to 24hours)
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 16 Sep 2021.
- Individual participant dataSharing planned: No
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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.
Sonja Dhani, PhD study director
Purdue Pharma, Canada
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methoxyflurane 3mL in people with Pain, Acute, run by Purdue Pharma, Canada at 6 sites in Canada.
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 11 inclusion and 11 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in mean pain intensity: Numerical Rating Scale (time frame: 20 mins from start of administration (STA) of PENTHROX™). 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 16 Sep 2021.