Clinical Trials Register

Summary
EudraCT Number:	2017-002009-37
Sponsor's Protocol Code Number:	0517
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-05-17
Trial results	View 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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Denmark - DHMA

A.2

EudraCT number

2017-002009-37

A.3

Full title of the trial

"The effect of Betamethasone gel and NSAID gel lubricated on the laryngeal mask on pain in the throat, hoarseness and cough after anesthesia. "

“Effekten af Betamethason gel og NSAID gel smurt på Laryngsmasken på smerter i halsen, hæshed og hoste efter narkose.”

A.3.1

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

"The effect of Betamethasone gel and NSAID gel lubricated on the laryngeal mask on pain in the throat, hoarseness and cough after anesthesia. "

“Effekten af Betamethason gel og NSAID gel smurt på Laryngsmasken på smerter i halsen, hæshed og hoste efter narkose.”

A.4.1

Sponsor's protocol code number

0517

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Neuroanæstesiologisk Klinik, RH/Glostrup
B.1.3.4	Country
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Neuroanæstesiologisk Klinik, RH/Glostrup
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Neuroanæstesiologisk Klinik, RH/Glostrup
B.5.2	Functional name of contact point	Neuroanæstesiologisk Klinik, RH/Glo
B.5.3	Address:
B.5.3.1	Street Address	Nordre Ringvej 57
B.5.3.2	Town/ city	Glostrup
B.5.6	E-mail	mark.puch.oernskov@regionh.dk

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
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	Ipren gel 50 mg/g.
D.2.1.1.2	Name of the Marketing Authorisation holder	Takeda Pharma A/S
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intrathecal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	IBUPROFEN
D.3.9.3	Other descriptive name	Ipren
D.3.9.4	EV Substance Code	SUB08098MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	50,0
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	No
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Diprolen gel 0,5 mg/g
D.2.1.1.2	Name of the Marketing Authorisation holder	MSD Danmark Aps
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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.3.4	Pharmaceutical form	Gel
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intrathecal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Diprolen
D.3.9.1	CAS number	378-44-9
D.3.9.3	Other descriptive name	BETAMETHASONE
D.3.9.4	EV Substance Code	SUB05797MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/g milligram(s)/gram
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0,5
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	No
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	Gel
D.8.4	Route of administration of the placebo	Intrathecal use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

'Healthy volunteers' (sore throat, hoarseness and cough, consumption of analgesics, postoperative itching, numbness and burning sensation from the throat)

'Raske frivillige' (ondt i halsen, hæshed og hoste, forbrug af analgetika, postoperativ kløe, følelsesløshed og brændende fornemmelse fra halsen)

E.1.1.1

Medical condition in easily understood language

'Healthy volunteers' (sore throat, hoarseness and cough, consumption of analgesics, postoperative itching, numbness and burning sensation from the throat)

'Raske frivillige' (ondt i halsen, hæshed og hoste, forbrug af analgetika, postoperativ kløe, følelsesløshed og brændende fornemmelse fra halsen)

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	20.0
E.1.2	Level	SOC
E.1.2	Classification code	10022891
E.1.2	Term	Investigations
E.1.2	System Organ Class	10022891 - Investigations

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The main objektive of the Sub-study is to investigate the effect of Betamethason gel and NSAID gel lubricated on the Flexible laryngeal mask (FLMA) on the occurrence and strength of sore throat, hoarseness and cough in compared to a placebo group (Neutral Gel) and compared to each other. Our hypothesis is that Betamethasone Gel will be the most effective of the 2 active substances.

Vort formål med pilotstudiet er, at undersøge effekten af Betamethason gel og NSAID gel smurt på den Fleksible Laryngsmaske (FLMA) på forekomsten og styrken af smerter i halsen, hæshed og hoste i forhold til en placebogruppe (Neutral gel) og i forhold til hinanden. Vor hypotese er, at Betamethason gel vil være det mest effektive af de 2 aktive stoffer.

E.2.2

Secondary objectives of the trial

• The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on the sore throat at 2, 4, 8 and 24 hours (T2, T4, T8, T24) after FLMA removal (T0).
• The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on hoarseness and cough at 2, 4, 6, 8 and 24 hours ( T2, T4, T6, T8, T24) after FLMA removal (T0).
• The consumption of analgesics at 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0).
• The occurrence of postoperative itching, numbness and burning sensation from the neck at 2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0).

• Effekten og forskellen mellem Betamethason gel (Diprolen 0,05 %), NSAID gel (Ipren gel 0,5 %)og placebo (Neutral gel) påsmurt FLMA på ondt i halsen til tiden 2, 4, 8 og 24 timer (T2,T4,T8,T24) efter FLMA fjernelse (T0).
• Effekten og forskellen mellem Betamethason gel (Diprolen 0,05 %), NSAID gel (Ipren gel 0,5 %)og placebo (Neutral gel) påsmurt FLMA på hæshed og hoste til tiden 2, 4, 6, 8 og 24 timer (T2,T4,T6,T8,T24) efter FLMA fjernelse (T0).
• Forbruget af analgetika til tiden 2, 4, 6, 8 og 24 timer (T2,T4,T6,T8,T24) efter FLMA fjernelse (T0).
• Forekomsten af postoperativ kløe, følelsesløshed og brændende fornemmelse fra hals til tiden 2, 4, 6, 8 og 24 timer (T2,T4,T6,T8,T24) efter FLMA fjernelse (T0).

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patients who understand and speak Danish
• The patient set for eye surgery in general anesthesia with FLMA as airway management.
• Age ≥18 years
• ASA 1-3.
• BMI ≥18 and ≤40
• Patients without cognitive disorders that may prevent relevant responses in the study.
• Patients without upper respiratory tract infection.
• Patients who are not in steroid treatment before surgery.
• Patients who do not have an allergy to the substances used in the pilot study. (See side effects page 5)
• Patients who have given their written informed consent to participate in the study after understanding the contents and limitations of the protocol.

• Patienter, som forstår og taler dansk
• Patienten indstillet til øjenkirurgi i generel anæstesi med FLMA som luftvejshåndtering.
• Alder ≥18 år
• ASA 1-3.
• BMI ≥18 og ≤40
• Patienter uden kognitive lidelser, som kan hindre relevant svar i undersøgelsen.
• Patienter uden øvre luftvejsinfektion.
• Patienter, som ikke er i steroidbehandling før operation.
• Patienter, som ikke har allergi over for de i pilotstudiet anvendte stoffer. (se Bivirkninger side 5)
• Patienter, som har givet deres skriftlige informerede samtykke til at deltage i undersøgelsen efter at have forstået protokollens indhold og begrænsninger.

E.4

Principal exclusion criteria

Study participants who do not meet one or more of the inclusion criteria are not suitable for inclusion in this pilot study.

Studiedeltagere, der ikke opfylder et eller flere af ovenstående kriterier, er ikke egnede til inklusion i dette pilotstudie.

E.5 End points

E.5.1

Primary end point(s)

The effect and difference between Betamethasone gel (Diprol 0.05%), NSAID gel (Ipren gel 0.5%) and placebo (Neutral gel) lubricated FLMA on the sore throat at time 6 hours (T6) after FLMA removal (T0).

Effekten og forskellen mellem Betamethason gel (Diprolen 0,05 %), NSAID gel (Ipren gel 0,5 %)og placebo (Neutral gel) påsmurt FLMA på ondt i halsen til tiden 6 timer (T6) efter FLMA fjernelse (T0).

E.5.1.1

Timepoint(s) of evaluation of this end point

6 hours (T6) after FLMA removal (T0).

6 timer (T6) efter FLMA fjernelse (T0).

E.5.2

Secondary end point(s)

E.5.2.1

Timepoint(s) of evaluation of this end point

2, 4, 6, 8 and 24 hours (T2, T4, T6, T8, T24) after FLMA removal (T0).

2, 4, 6, 8 og 24 timer (T2,T4,T6,T8,T24) efter FLMA fjernelse (T0).

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Et åben, ikke-randomiseret, kontrolleret pilot-studie

An open, non randomised, controlled sub-study

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

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

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

'LVLS'

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 months

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

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)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

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

Yes

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

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)

none

ingen

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

2017-07-14

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-08-15

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials