Clinical Trials Register

Summary
EudraCT Number:	2011-000338-12
Sponsor's Protocol Code Number:	MEOF-001
National Competent Authority:	UK - MHRA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-04-11
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

UK - MHRA

A.2

EudraCT number

2011-000338-12

A.3

Full title of the trial

A randomised, double blind, multi-centre, placebo controlled study to evaluate the efficacy and safety of methoxyflurane (Penthrox(TM)) for the treatment of acute pain in patients presenting to an Emergency Department with minor trauma

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

A study to learn more about the effects of a pain relief medicine called methoxyflurane (known as Penthrox(TM)) on pain caused by a minor injury. The effects will be compared to a dummy medicine

A.4.1

Sponsor's protocol code number

MEOF-001

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/210/2009

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Medical Developments International Limited
B.1.3.4	Country	Australia
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Medical Developments International Limited
B.4.2	Country	Australia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	ORION Clinical Services Ltd
B.5.2	Functional name of contact point	Clinical Ops & Regulatory Affairs
B.5.3	Address:
B.5.3.1	Street Address	7 Bath Road
B.5.3.2	Town/ city	Slough
B.5.3.3	Post code	SL1 3UA
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	0044175357 8080
B.5.5	Fax number	0044175357 8081
B.5.6	E-mail	orion@orioncro.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Penthrox(TM)
D.2.1.1.2	Name of the Marketing Authorisation holder	Medical Developments International Limited
D.2.1.2	Country which granted the Marketing Authorisation	Australia
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Penthrox(TM)
D.3.4	Pharmaceutical form	Inhalation solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Inhalation use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Methoxyflurane
D.3.9.1	CAS number	76-38-0
D.3.9.4	EV Substance Code	SUB08858MIG
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Yes
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Inhalation solution
D.8.4	Route of administration of the placebo	Inhalation use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Acute pain

E.1.1.1

Medical condition in easily understood language

Pain caused by a minor injury

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10066714
E.1.2	Term	Acute pain
E.1.2	System Organ Class	10018065 - General disorders and administration site conditions

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Evaluate the efficacy of methoxyflurane (Penthrox™) for the treatment of acute pain in patients presenting to an ED with minor trauma.

E.2.2

Secondary objectives of the trial

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

E.2.3

Trial contains a sub-study

E.3

Principal 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.

E.4

Principal 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.

E.5 End points

E.5.1

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.

E.5.1.1

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.

E.5.2

Secondary end point(s)

Evaluation of Adverse Events (AEs) experienced during treatment, not associated with the underlying minor trauma.

E.5.2.1

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.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

Last Patient Last Visit

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

216

F.4.2

For a multinational trial

F.4.2.1

In the EEA

300

F.4.2.2

In the whole clinical trial

300

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

Normal standard care

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-05-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-06-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-08-17

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