A Phase 3 interventional study of Methoxyflurane and Standard of care in Acute Pain Due to Trauma, sponsored by Mundipharma Pharmaceuticals S.L.. Completed at 14 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-20.
Sponsored by Mundipharma Pharmaceuticals S.L. (part of Mundipharma) · Phase 3, Interventional, and Treatment
Clinical trial to compare pain relief between methoxyflurane and any analgesic treatment used in usual clinical practice, in patients with trauma and associated pain, treated in Spanish emergency units.
Open, randomized clinical trial to compare emergency pain relief between methoxyflurane and standard of care in patients with trauma and associated pain, treated in Spanish emergency units.
Methoxyflurane is a fluorinated ethyl methyl ether, with the chemical name 2:2-dichloro-1:1-difluoroethyl methyl ether. It belongs to the fluorinated hydrocarbon group of volatile anaesthetics. It is inhaled as a vapour at low (sub-anaesthetic) concentrations to achieve an analgesic effect for the management of pain.
In Europe countries, where methoxyflurane is already marketed, it is indicated for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain.
On the other hand, current clinical practice includes a variety of analgesic agents, with the choice of which to employ based on consideration of the risk-benefit factors of each class of drug, as well as the type of pain, its severity, and the risk of adverse effects.
The main objective of this study is to assess Methoxyflurane's significant advantage in terms of anaglesic effectiveness, as it is known as a rapidly acting, non-narcotic analgesic for the treatment of emergency pain.
Mundipharma Pharmaceuticals S.L. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will be supplied with up to two inhalers containing 3 mL methoxyflurane. A member of the research team will train the patient to self-administer methoxyflurane
Drug: Methoxyflurane
Patients will be treated following standard of care (SoC) of the hospital, for emergency relief of trauma and associated pain. Any kind of analgesia administered by any route will be valid. Only administration of one analgesic (or fixed combinations) at baseline will considered SoC. Other required analgesics will be considered rescue medication.
Drug: Standard of care
Up to two inhalers containing 3 mL methoxyflurane. Treatment duration: 1 administration in 1 day.
Also known as: No other interventions
Any kind of analgesia, administered by any route for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain
Also known as: No other interventions
Pain relief
Change in mean pain intensity over 20 min from start of administration (STA) and time to first pain relief, measured by numeric scale (0-10)
Time frame: At baseline, 3, 5, 10, 15 and 20 minutes from STA
Analgesia effectiveness
Difference between arms related to analgesia effectiveness
Time frame: Change from baseline to 3, 5, 10, 15, 20 and 30 min
Analgesia speed of action
Difference between arms related to speed of action of analgesia for all patients
Time frame: From time of randomization up to 20 minutes
Safety for patients with severe pain, treated with second or third step analgesics
Difference between arms related to safety for patients with severe pain (NRS \>7), treated with second or third step analgesics
Time frame: Up until 14 days from STA
Patient-averaged summed pain intensity difference 15 min after STA
Patient-averaged summed pain intensity difference 15 min after STA
Time frame: from baseline to 3, 5, 10 and 15 minutes post dose
Pain Responders
Pain Responders (with \>30% pain relief compared to baseline) at 20 min
Time frame: from baseline to 20 minutes post dose
Investigators and patients satisfaction
Investigators and patients satisfaction measured as convenience, treatment efficacy and adverse events, using NRS scales (0-10)
Time frame: 30 min from start of administration
Patient and investigators' fulfillment of expectations
Patient and investigators' fulfillment of expectations, measured with a 5 items Likert scale
Time frame: 30 min from start of administration
Patients' Global Impression of Change with the treatments
Patients' Global Impression of Change with the treatments, measured using a 7 items Likert scale
Time frame: Up until 30 minutes from STA
Treatment cost of pain relief
Treatment cost of pain relief, measured considering use of fungible material; need of nurse to administer iv treatments; time to discharge
Time frame: Up until 60 minutes from randomization
Safety rates of treatment emergent adverse events
Safety rates of treatment emergent adverse events (TEAE) in both arms, including alterations in biochemical and blood count.
Time frame: Up until 14 days from STA
Plan to share: Undecided
Ran from Jul 2017 to primary completion in Mar 2018, 7 months.
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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Methoxyflurane