Clinical Trials Register

Summary
EudraCT Number:	2014-002306-21
Sponsor's Protocol Code Number:	P2014/PE2
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2014-12-12
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2014-002306-21

A.3

Full title of the trial

Monocentric, prospective randomized controlled clinical trial assessing the effect on the lower limb spinal motoneuron excitability, the efficacy in term of morphinic sparing and safety of of early clonidin bolus intravenous administration during general anesthesia in children and adolescent 6-18 years old requesting reconstructive tympanic surgery.

Essai clinique monocentrique, prospectif, randomisé en double aveugle versus placebo, évaluant l'effet sur l'excitabilité du motoneurone spinal du membre inférieur, l'efficacité en terme d'épargne morphinique et la sécurité de la clonidine administrée précocément en bolus intraveineux durant l'anesthésie générale chez des enfants et adolescents âgés de 6 à 18 ans subissant une chirurgie reconstructrice du tympan.

A.3.1

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

Effect of a bolus of clonidine systemically administered on the excitability of the spinal motoneurons of the lower extremity

Effet de l’administration systémique d’un bolus de clonidine sur l’excitabilité du motoneurone spinal du membre inférieur

A.3.2

Name or abbreviated title of the trial where available

EXCICLON Study

A.4.1

Sponsor's protocol code number

P2014/PE2

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	Hôpital Universitaire Des Enfants Reine Fabiola
B.1.3.4	Country	Belgium
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	HôpitalUniversitaire Des Enfants Reine Fabiola
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hôpital Universitaire Des Enfants Reine Fabiola
B.5.2	Functional name of contact point	Clinical Research Unit
B.5.3	Address:
B.5.3.1	Street Address	Avenue Jean-Joseph Crocq 15
B.5.3.2	Town/ city	Brussels
B.5.3.3	Post code	1020
B.5.3.4	Country	Belgium
B.5.4	Telephone number	0032 2477 36 54
B.5.5	Fax number	0032 2477 38 97
B.5.6	E-mail	bernard.wenderickx@huderf.be

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	Catapressan
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Catapressan
D.3.9.3	Other descriptive name	CLONIDINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB01362MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
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	Solution for injection
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Peri and post operative pain management

Gestion de la douleur per et post-opératoire

E.1.1.1

Medical condition in easily understood language

Peri and post operative pain management

Gestion de la douleur per et post-opératoire

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	17.1
E.1.2	Level	LLT
E.1.2	Classification code	10036236
E.1.2	Term	Postoperative pain relief
E.1.2	System Organ Class	100000004865

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Must be completed

Mesurer l’effet de l’administration systémique d’un bolus de clonidine sur l’excitabilité du motoneurone spinal du membre inférieur lors d’une anesthésie intraveineuse standardisée (propofol et rémifentanil)

E.2.2

Secondary objectives of the trial

Must be completed

1. Evaluer les consommations peropératoires totales de rémifentanyl et de propofol
2. Evaluer les scores de douleur en salle de réveil
3. Evaluer les scores de sédation en salle de réveil
4. Evaluer les recours en antalgiques de pallier 2 (OMS)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients aged 6 to 18 years at time of hospital admission
2. Planned hospital admission for tympanosplasty
3. Informed Consent signed by both parents

1. Patients âgés de 6 à 16 ans au moment de l'admission
2. Patients admis pour chirurgie reconstructrice du tympan
3. Consentement écrit des parents

E.4

Principal exclusion criteria

1. Known hypersensitivity to clonidine or to any component of the Catapressan
2. Patient treated with alpha2 agonists
3. Surgical emergency
4. Patient treated with antipsychotic drugs(butyrophenone, phenothiazine, tricyclic antidepressant)
5. Abnormal heart rhythms
6. Neuromuscular disease
7. Renal impairment
8. Patient treated with methylphenidate
9. Pregnant or breastfeeding woman

1. Hypersensibilité au principe actif ou à l'un des composant du catapressant
2. Patient traité par alpha2 agonistes
3. chirurgie en urgence
4. Patient traité par antipsychotiques (butyrophènone, phénothiazine, antidépresseurs tricycliques)
5. Patient présentant des troubles du rythme
6. Patient atteint d'une maladie neuromusculaire
7. Patient atteint d'une insuffisance rénale
8. Patient traité par Methylphénidate
9. Patiente enceinte ou allaitante

E.5 End points

E.5.1

Primary end point(s)

electrophysiological parameters of H-reflex and F-wave

mesure du réflexe H et des ondes F

E.5.1.1

Timepoint(s) of evaluation of this end point

Continuously throughout the anesthesia

En continu durant l'anesthésie

E.5.2

Secondary end point(s)

1. Total dose of propofol and remifentanyl in mg/kg administered througout the perioperative period
2. Pain score using the CHEOPS/EVA scale
3. Sedative score using the UMSS scale
4. Total dose of step 2 analgesic (tramadol) used for pain management

1. Dose totale en mg/kg de propofol et remifentanil administré en peropératoire
2. Score de douleur par l'échelle CHEOPS / EVA (Selon l'âge et l'état cognitif de l'enfant)
3. Score de sédation par l'échelle UMSS
4. Dose totale en mg/kg d'antalgique(s) de palier 2 (tramadol)

E.5.2.1

Timepoint(s) of evaluation of this end point

1. peri-operative period, started the asministration of clonidine to the end of the surgery
2. Pain scores will be assessed every 30min while the patient stay in the recovery room
3. Sedative scores will be assessed every 30min while the patient stay in the recovery room
4. Total dose of step 2 analgesic administered during the postanesthesia recovery period

1. Période peropératoire, après injection de la clonidine jusqu'à la fin de l'intervention
2. Score de douleur mesuré mesuré toutes les 30min durant le séjour du patient en salle de réveil
3. Score de sédation mesuré toutes les 30min durant le séjour du patient en salle de réveil
4. Total dose d'antalgique(s) de palier 2 administrée durant le séjour du patient en salle de réveil

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

Yes

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

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

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

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

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)

F.1.3

Elderly (>=65 years)

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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-12-12.

Yes

F.3.3.2

Women of child-bearing potential using contraception

Yes

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

children

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)

The patient Follow-Up will be performed according to local guidelines

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

2015-01-28

Ethics Committee Opinion of the trial application

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2022-01-01

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