Acute pain MedDRA version: 14.0 Level: LLT Classification code 10066714 Term: Acute pain System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Interventions
Trade Name: Penthrox(TM)
Product Name: Penthrox(TM)
Pharmaceutical Form: Inhalation solution
INN or Proposed INN: Methoxyflurane
CAS Number: 76-38-0
Concentration unit: ml millilitre(s)
Concentration
Sponsors
Medical Developments International Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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. 2. 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. 3. Pain Score = 4 to = 7 as measured using Numerical Rating Scale (NRS) at the time of admission, due to minor trauma. Are the trial subjects under 18? yes Number of subjects for this age range: 90 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Life-threatening condition requiring immediate admission in the Operating Room or Intensive Care Unit. 2. 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. 3. Unable to provide written informed consent. 4. Known pregnancy or lactation 5. Acute intoxication with drugs or alcohol, based on the judgement of the attending physician. 6. 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). 7. Current ongoing use of analgesics for chronic pain. 8. Use of an investigational product within one month prior to presentation to ED. 9. Known personal or familial hypersensitivity to fluorinated anaesthetics. 10. Known personal or familial history of malignant hyperthermia. 11. Clinically significant respiratory depression. 12. Use of methoxyflurane in the previous 4 weeks. 13. Known pre-existing clinically significant renal or hepatic impairment according to the judgement of the clinician. 14. Clinically significant cardiovascular instability.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of methoxyflurane (Penthrox™) for the treatment of acute pain in patients presenting to an ED with minor trauma. ;Secondary Objective: To evaluate the: • safety of the inhaled analgesic study drug for the treatment of acute pain in patients presenting to an Emergency Department with minor trauma; • efficacy of the inhaled analgesic study drug for the treatment of acute pain in patients with minor trauma during their time in the ED ;Primary end point(s): The primary analysis will be an intention-to-treat (ITT) analysis of the difference between treatment and placebo on the VAS pain score.;Timepoint(s) of evaluation of this end point: The primary model will be a repeated measures analysis of variance of the change from baseline to 5, 10, 15 and 20 minutes following the start of administration of study medication, adjusted for the baseline VAS score in the ITT population. The treatment effect will be estimated as the average difference between the methoxyflurane treated group and the placebo group at these time points. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of Adverse Events (AEs) experienced during treatment, not associated with the underlying minor trauma.;Timepoint(s) of evaluation of this end point: Evaluation of Adverse Events (AEs), including safety laboratory samples, up to 14 ± 2 days following ED discharge. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Ops & Regulatory Affairs
ORION Clinical Services Ltd
Outcome results
None listed