Acute Pain Due to TraumaPhase 3STOP!NCT01420159
Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Minor Trauma
A Phase 3 study testing Methoxyflurane in people with Acute Pain Due to Trauma, run by Medical Developments International Limited at 6 sites in United Kingdom.
Trial summary
This study investigates the treatment of acute pain, an unpleasant feeling caused by an injury. The overall purpose of the study is to gain more information that the pain relief medicine Penthrox(Methoxyflurane) administered using the Penthrox Inhaler(a distinctive green, whistle like object that you breathe through)… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Pain Due to Trauma
- What is being tested?
- Methoxyflurane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- Aug 2011to Jul 2012
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients 12 years of age or older who are able to give written informed consent or who are accompanied by a parent(s)/legal guardian able to provide written informed consent on their behalf.
- Evidence of signed and dated informed consent document(s) indicating that the patient (and/or a parent/legal guardian) has been informed of all pertinent aspects of the study.
- Pain Score ≥ 4 to ≤ 7 as measured using Numerical Rating Scale (NRS) at the time of admission, due to minor trauma.
Who cannot join
- Life-threatening condition requiring immediate admission in the Operating Room or Intensive Care Unit.
- Presence of any other clinical condition(s) that may, in the opinion of the investigator, impact on the patient's ability to participate in the study, or on the study results, including history of head injury and/or altered consciousness.
- Unable to provide written informed consent.
- Known pregnancy or lactation
- Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
- Treatment with any analgesic agent within 5 hours prior to presentation to ED (except diclofenac sodium which is prohibited within 8 hours prior to presentation to ED).
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- Current ongoing use of analgesics for chronic pain.
- Use of an investigational product within one month prior to presentation to ED.
- Known personal or familial hypersensitivity to fluorinated anaesthetics.
- Known personal or familial history of malignant hyperthermia.
- Clinically significant respiratory depression.
- Use of methoxyflurane in the previous 4 weeks.
- Known pre-existing clinically significant renal or hepatic impairment according to the judgement of the clinician.
- Clinically significant cardiovascular instability.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Barnsley District General Hospital
Barnsley, S75 2EP
Birmingham Children's Hospital NHS Foundation Trust
Birmingham, B4 6NH
Colchester General Hospital
Colchester, CO4 5JL
James Cook University Hospital
Middlesbrough, TS4 3BW
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Nottingham University Hospitals NHS Trust, Queen's Medical Centre Campus
Nottingham, NG7 2UH
About this study
Official title: A Randomised, Double Blind, Multi-centre, Placebo Controlled Study to Evaluate the Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Patients Presenting to an Emergency Department With Minor Trauma
This study investigates the treatment of acute pain, an unpleasant feeling caused by an injury. The overall purpose of the study is to gain more information that the pain relief medicine Penthrox(Methoxyflurane) administered using the Penthrox Inhaler(a distinctive green, whistle like object that you breathe through) is safe and works at relieving pain in patients aged 12 years and older who are admitted to a hospital Emergency Department with a minor injury (known as trauma).
- Conditions
- Acute Pain Due to Trauma
- Being tested
- Methoxyflurane
- Keywords
- Pain, Trauma, Analgesia
- Medical subject headings
- Pain, Wounds and Injuries, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxyfluraneDrug
Also called Penthrox
Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.
| Study group | Role | What they receive |
|---|---|---|
| Methoxyflurane | Experimental | Not described Receives: Drug: Methoxyflurane |
| Normal Saline | Placebo comparator | Not described Receives: Drug: Methoxyflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS Score
The difference between treatment and placebo on the VAS pain score
Measured: Twenty Minutes
Secondary outcomes (4)
Rescue Medication
A request for rescue medication, time of request for rescue medication and the quantity of opioid equivalent rescue medication administered will be measured
Measured: Up to a maximum of 6 hours
Time to pain relief
The number of inhalations of study treatment until pain relief is achieved and the time until pain relief is achieved.
Measured: Up to a maximum of 6 hours
Responder analysis
The number of responders will be defined
Measured: Up to a maximum of 6 hours
Safety Analysis
Evaluation of Adverse Events experienced during treatment. Evaluation of Adverse Events, including safety laboratory samples, up to 14 +/- 2 days following Emergency Department discharge
Measured: Up to 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute Pain Due to TraumaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Developments International Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ORION Clinical Services
- Responsible party
- Sponsor
- Investigators
- Frank M Coffey, Principal investigator, Nottingham University Hospitals, Queen's Medical Centre Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420159
- Sponsor's protocol ID
- MEOF-001
- Acronym
- STOP!
- Status last verified
- Oct 2012
- First submitted
- 11 Aug 2011
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hartshorn S, Dissmann P, Coffey F, Lomax M. Low-dose methoxyflurane analgesia in adolescent patients with moderate-to-severe trauma pain: a subgroup analysis of the STOP! study. J Pain Res. 2019 Feb 15;12:689-700. doi: 10.2147/JPR.S188675. eCollection 2019.
PubMed 30863141Coffey F, Dissmann P, Mirza K, Lomax M. Methoxyflurane Analgesia in Adult Patients in the Emergency Department: A Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study (STOP!). Adv Ther. 2016 Nov;33(11):2012-2031. doi: 10.1007/s12325-016-0405-7. Epub 2016 Aug 27.
PubMed 27567918Coffey F, Wright J, Hartshorn S, Hunt P, Locker T, Mirza K, Dissmann P. STOP!: a randomised, double-blind, placebo-controlled study of the efficacy and safety of methoxyflurane for the treatment of acute pain. Emerg Med J. 2014 Aug;31(8):613-8. doi: 10.1136/emermed-2013-202909. Epub 2014 Apr 17.
PubMed 24743584
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double Blind, Multi-centre, Placebo Controlled Study to Evaluate the Efficacy and Safety of Methoxyflurane (Penthrox) for the Treatment of Acute Pain in Patients Presenting to an Emergency Department With Minor Trauma
- ClinicalTrials.gov ID
- NCT01420159
- Acronym / sponsor ID
- STOP! / MEOF-001
- Conditions
- Acute Pain Due to Trauma
- Keywords
- Pain, Trauma, Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Medical Developments International LimitedIndustry (pharma, biotech, devices)
- Collaborators
- ORION Clinical Services
- Study start
- Aug 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 19 Aug 2011 (estimated)
- 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 study investigates the treatment of acute pain, an unpleasant feeling caused by an injury. The overall purpose of the study is to gain more information that the pain relief medicine Penthrox(Methoxyflurane) administered using the Penthrox Inhaler(a distinctive green, whistle like object that you breathe through) is safe and works at relieving pain in patients aged 12 years and older who are admitted to a hospital Emergency Department with a minor injury (known as trauma).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methoxyflurane | Experimental | Drug: Methoxyflurane |
| Normal Saline | Placebo comparator | Drug: Methoxyflurane |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients 12 years of age or older who are able to give written informed consent or who are accompanied by a parent(s)/legal guardian able to provide written informed consent on their behalf.
- Evidence of signed and dated informed consent document(s) indicating that the patient (and/or a parent/legal guardian) has been informed of all pertinent aspects of the study.
- Pain Score ≥ 4 to ≤ 7 as measured using Numerical Rating Scale (NRS) at the time of admission, due to minor trauma.
Key exclusion criteria (14 listed)
- Life-threatening condition requiring immediate admission in the Operating Room or Intensive Care Unit.
- Presence of any other clinical condition(s) that may, in the opinion of the investigator, impact on the patient's ability to participate in the study, or on the study results, including history of head injury and/or altered consciousness.
- Unable to provide written informed consent.
- Known pregnancy or lactation
- Acute intoxication with drugs or alcohol, based on the judgement of the attending physician.
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 |
|---|---|---|
| MethoxyfluraneAlso: PenthroxPatients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered. | Drug | Methoxyflurane, Normal Saline |
Primary outcome
VAS Score
Time frame: Twenty Minutes
The difference between treatment and placebo on the VAS pain score
4 secondary outcomes
Rescue Medication
Time frame: Up to a maximum of 6 hours
Time to pain relief
Time frame: Up to a maximum of 6 hours
Responder analysis
Time frame: Up to a maximum of 6 hours
Safety Analysis
Time frame: Up to 16 days
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 31 Oct 2012.
- Derived from this study: PubMed 30863141Hartshorn S, Dissmann P, Coffey F, Lomax M. Low-dose methoxyflurane analgesia in adolescent patients with moderate-to-severe trauma pain: a subgroup analysis of the STOP! study. J Pain Res. 2019 Feb 15;12:689-700. doi: 10.2147/JPR.S188675. eCollection 2019.
- Derived from this study: PubMed 27567918Coffey F, Dissmann P, Mirza K, Lomax M. Methoxyflurane Analgesia in Adult Patients in the Emergency Department: A Subgroup Analysis of a Randomized, Double-blind, Placebo-controlled Study (STOP!). Adv Ther. 2016 Nov;33(11):2012-2031. doi: 10.1007/s12325-016-0405-7. Epub 2016 Aug 27.
- Derived from this study: PubMed 24743584Coffey F, Wright J, Hartshorn S, Hunt P, Locker T, Mirza K, Dissmann P. STOP!: a randomised, double-blind, placebo-controlled study of the efficacy and safety of methoxyflurane for the treatment of acute pain. Emerg Med J. 2014 Aug;31(8):613-8. doi: 10.1136/emermed-2013-202909. Epub 2014 Apr 17.
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.
Frank M Coffey principal investigator
Nottingham University Hospitals, Queen's Medical Centre Campus
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methoxyflurane in people with Acute Pain Due to Trauma, run by Medical Developments International Limited at 6 sites in United Kingdom.
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 3 inclusion and 14 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 31 Oct 2012. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
VAS Score (time frame: Twenty Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01420159, which also lists 3 linked publications.
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 31 Oct 2012.