PainPhase 4MOUNTAIN-PAINNCT03849027
MethOxyflUraNe at moderaTe High AltItudes for PAIN Management
A Phase 4 study testing Methoxyflurane in people with Pain, run by University of Cape Town at 1 site in South Africa.
Trial summary
A randomised, double-blind, cross-over study to assess the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting. Phase IV, randomised, double-blind, cross-over clinical trial to evaluate the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Methoxyflurane
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2019to Dec 2019
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 65 years of age (inclusive).
- Able to provide informed consent and comply with study-related procedures
Who cannot join
- History of diabetes
- Renal or hepatic disease or impairment (defined as a value exceeding the maximum reference range)
- Chronic or nociplastic pain
- Chronic fatigue syndrome
- Chronic/regular use of analgesic medications
- Personal or familial history of malignant hyperthermia
Show all 14Show fewer
- Personal or familial history of anaesthesia-induced rhabdomyolysis
- Personal history of anaesthesia volatile-induced hepatitis or drug induced liver injury
- Recent volatile anaesthesia (within 6 months)
- History of significant altitude-related illness
- Significant underlying medical condition which precludes gentle exercise at moderate high altitude (<2500 m ASL) as determined by the investigators
- Hypersensitivity to Penthrox/Penthrop®, methoxyflurane or any fluorinated anaesthetic.
- Concurrent treatment with CYP 2A6 or CYP 2E1 enzyme inducers (such as: phenobarbital, rifampicin, alcohol or isoniazid)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Africa1 site
University of Cape Town Department of Anaesthesia & Perioperative Medicine
Cape Town, Western Cape, 7925
Ross Hofmeyr, +2721 650 4957, ross.hofmeyr@uct.ac.za
Nicky Kramer, +2721 650 4196, nicky.kramer@uct.ac.za
About this study
Official title: MethOxyflUraNe at moderaTe High AltItudes for PAIN Management: A Randomised, Double-blind, Cross-over Study
A randomised, double-blind, cross-over study to assess the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting.
Phase IV, randomised, double-blind, cross-over clinical trial to evaluate the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting, in 24 healthy volunteers
Read the detailed description
Primary outcome: To assess the analgesic efficacy of inhaled methoxyflurane at moderate high altitudes in a wilderness setting.
Secondary outcomes: To assess the comparative safety and adverse events with inhaled methoxyflurane at moderate high altitudes in a wilderness setting.
- Conditions
- Pain
- Being tested
- Methoxyflurane, Placebo
- Keywords
- altitude, analgesia, methoxyflurane, wilderness medicine
- Medical subject headings
- Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethoxyfluraneDrug
Also called Penthrop, Penthrox
Inhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®) according to the recommended dosing schedule.
PlaceboDrug
Also called Sham methoxyflurane
The sham inhaler will have one droplet of methoxyflurane applied to the outer surface, but no drug in the vaporization chamber to give off the prominent odour with no analgesic effect, partially blinding the participants to the test.
| Study group | Role | What they receive |
|---|---|---|
| Methoxyflurane | Experimental | Inhaled methoxyflurane once-off dose of 3 ml will be administered via the inhaler at each dosing visit .
Inhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®). Receives: Drug: Methoxyflurane |
| Sham Methoxyflurane | Sham comparator | The sham inhaler will have one droplet of methoxyflurane applied to the outer surface, but no drug in the vaporization chamber to give off the prominent odour with no analgesic effect, partially blinding the participants to the test Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic effect
Percentage change in analgesic effect between methoxyflurane inhalation at sea level (ALT 0) and 2250m (ALT 2; moderate high altitude).
Measured: Up to 3 weeks
Secondary outcomes (1)
Safety and adverse events
Comparative safety and adverse events with inhaled methoxyflurane at moderate high altitudes in a wilderness setting
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study startMay 2019 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Randomised
- Intervention model
- Crossover
- Model description
- randomised, controlled, cross-over
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ross Hofmeyr, University of Cape Town
- Investigators
- Ross Hofmeyr, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849027
- Sponsor's protocol ID
- MOUNTAIN-PAIN
- Acronym
- MOUNTAIN-PAIN
- Status last verified
- Feb 2019
- First submitted
- 18 Feb 2019
- Last updated
- 21 Feb 2019
- 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 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MethOxyflUraNe at moderaTe High AltItudes for PAIN Management: A Randomised, Double-blind, Cross-over Study
- ClinicalTrials.gov ID
- NCT03849027
- Acronym / sponsor ID
- MOUNTAIN-PAIN / MOUNTAIN-PAIN
- Conditions
- Pain
- Keywords
- altitude, analgesia, methoxyflurane, wilderness medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Study start
- May 2019 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 21 Feb 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.
A randomised, double-blind, cross-over study to assess the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting.
Phase IV, randomised, double-blind, cross-over clinical trial to evaluate the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting, in 24 healthy volunteers
Detailed description
Primary outcome: To assess the analgesic efficacy of inhaled methoxyflurane at moderate high altitudes in a wilderness setting.
Secondary outcomes: To assess the comparative safety and adverse events with inhaled methoxyflurane at moderate high altitudes in a wilderness setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomised, controlled, cross-over
| Arm | Type | Receives |
|---|---|---|
| Methoxyflurane | Experimental | Drug: MethoxyfluraneInhaled methoxyflurane once-off dose of 3 ml will be administered via the inhaler at each dosing visit . Inhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®). |
| Sham Methoxyflurane | Sham comparator | Drug: PlaceboThe sham inhaler will have one droplet of methoxyflurane applied to the outer surface, but no drug in the vaporization chamber to give off the prominent odour with no analgesic effect, partially blinding the participants to the test |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female between 18 and 65 years of age (inclusive).
- Able to provide informed consent and comply with study-related procedures
Key exclusion criteria (14 listed)
- History of diabetes
- Renal or hepatic disease or impairment (defined as a value exceeding the maximum reference range)
- Chronic or nociplastic pain
- Chronic fatigue syndrome
- Chronic/regular use of analgesic medications
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: Penthrop, PenthroxInhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®) according to the recommended dosing schedule. | Drug | Methoxyflurane |
| PlaceboAlso: Sham methoxyfluraneThe sham inhaler will have one droplet of methoxyflurane applied to the outer surface, but no drug in the vaporization chamber to give off the prominent odour with no analgesic effect, partially blinding the participants to the test. | Drug | Sham Methoxyflurane |
Primary outcome
Analgesic effect
Time frame: Up to 3 weeks
Percentage change in analgesic effect between methoxyflurane inhalation at sea level (ALT 0) and 2250m (ALT 2; moderate high altitude).
1 secondary outcome
Safety and adverse events
Time frame: Up to 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
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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.
Ross Hofmeyr principal investigator
University of Cape Town
1 site 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 in people with Pain, run by University of Cape Town at 1 site in South Africa.
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 2 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: status not confirmed, as of the sponsor's last update on 21 Feb 2019. 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 South Africa. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ross Hofmeyr (+2721 650 4957, ross.hofmeyr@uct.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic effect (time frame: Up to 3 weeks). 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 21 Feb 2019.