Clinical Trials Register

Summary
EudraCT Number:	2011-004206-19
Sponsor's Protocol Code Number:	ABR36861
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-09-07
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

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2011-004206-19

A.3

Full title of the trial

Patient and Endoscopist Satisfaction with DEXmedetomidine versus Propofol/Alfentanil sedation during oesophagus interventions (PESDEX).

Ondervindingen van patiënten en endoscopist met dexmedetomidine versus propofol/alfentanil tijdens esofagus interventies

A.3.1

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

Patient and gastroenterologist satisfaction with different forms of sedation during oesophagus intervention.

Ondervindingen van patiënt en endoscopist met twee verschillende sedatie regimes tijdens esofagus interventies

A.3.2

Name or abbreviated title of the trial where available

Patient and endoscopist experiences with sedation.

Bevindingen van patiënten en endoscopist met sedatie.

A.4.1

Sponsor's protocol code number

ABR36861

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	AMC
B.1.3.4	Country	Netherlands
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	AMC
B.4.2	Country	Netherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AMC
B.5.2	Functional name of contact point	Clinical Trial information
B.5.3	Address:
B.5.3.1	Street Address	Meibergdreef 9
B.5.3.2	Town/ city	Amsterdam
B.5.3.3	Post code	1100DD
B.5.3.4	Country	Netherlands
B.5.4	Telephone number	+31205662533
B.5.5	Fax number	+31206979441
B.5.6	E-mail	M.W.Hollmann@amc.uva.nl

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	Propofol-Lipuro 10mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	B.Braun Melsungen AG
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Propofol-Lipuro
D.3.4	Pharmaceutical form	Infusion
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	PROPOFOL
D.3.9.1	CAS number	2078-54-8
D.3.9.4	EV Substance Code	SUB10116MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	10
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	Yes
D.3.11.13.1	Other medicinal product type	anaesthetic agent
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	Rapifen
D.2.1.1.2	Name of the Marketing Authorisation holder	Janssen-Cilag B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Rapifen
D.3.4	Pharmaceutical form	Infusion
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	ALFENTANIL HYDROCHLORIDE
D.3.9.1	CAS number	69049-06-5
D.3.9.4	EV Substance Code	SUB00339MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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	Yes
D.3.11.13.1	Other medicinal product type	opioid analgesic
D.IMP: 3
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	No
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	Precedex
D.3.4	Pharmaceutical form	Powder and solvent for solution for infusion
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.3.9.1	CAS number	145108-58-3
D.3.9.3	Other descriptive name	DEXMEDETOMIDINE HYDROCHLORIDE
D.3.9.4	EV Substance Code	SUB20317
D.3.10	Strength
D.3.10.1	Concentration unit	µg/ml microgram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	Yes
D.3.11.13.1	Other medicinal product type	sedative anesthetic agent

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Patients undergoing therapeutically esophageal interventions under sedation (dexmedetomidine or propofol/alfentanil) given by trained anesthesia nurse.

Patiënten die een therapeutisch oesofagus ingreep moeten ondergaan, onder sedatie (dexmedetomidine of propofol / alfentanil) gegeven door getrainde anesthesie verpleegkundige.

E.1.1.1

Medical condition in easily understood language

Patients with an esophageal disease which is treated by means of endoscopic instruments. During this therapy patients will be sedated by trained anesthesia nurses.

Patiënten met een oesofageale ziekte die door middel van endoscopische instrumenten behandeld worden. Tijdens deze therapie worden de patiënten door getrainde anesthesie verpleegkundigen verdoofd.

E.1.1.2

Therapeutic area

Diseases [C] - Cancer [C04]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

How is the experience (e.g. satisfaction levels, pain score, sedation score reached) of patients and endoscopist with sedation by means of dexmedetomidine or propofol/alfentanil during oesophagus interventions? Are there differences between different sedation regimes in patients undergoing oesophageal intervention?

Hoe is de ervaring (bijvoorbeeld tevredenheid, pijn score, sedatie score) van patiënten en de endoscopist met sedatie obv. dexmedetomidine of propofol / alfentanil tijdens oesofagus interventies? Zijn er verschillen tussen de verschillende sedatie?

E.2.2

Secondary objectives of the trial

Which form of sedation is safer for the patient in regard to respiratory and cardiovascular problems? Surrogate parameters of pulmonary and cardiovascular problems are oxygen saturation (SO2) measured by pulse oximetry, exhaled CO2 (capnography), heart rate, arrhythmias (ECG) and blood pressure (non-invasive blood pressure measurement (NIBP).

Which regime minimizes patient flow time (induction time + procedure time + recovery time)?

Welke vorm van sedatie is veiliger voor de patiënt met betrekking tot ademhaling- en cardiovasculaire problemen? Surrogaat parameters van pulmonale en cardiovasculaire problemen zijn zuurstofverzadiging (SO2) gemeten door pulsoximetrie, uitgeademd CO2 (capnografie), hartslag, hartfrequentie (ECG) en bloeddruk (niet-invasieve bloeddrukmeting (NIBP). Welk regime minimaliseert patiëntenstroom tijd (inductie tijd + procedure tijd +hersteltijd)?

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The patients must comply with the following criteria in order to be eligible to participate in this clinical study:
Age range ≥ 18 years
ASA classification I – III
Patients, undergoing elective oesophagus intervention
Written informed consent

De patiënten moeten aan de volgende criteria voldoen om in aanmerking voor deelname aan deze klinische studie te komen:
Leeftijd ≥ 18 jaar
ASA classificatie I - III
Patiënten, die een oesofagus interventie ondergaan
Schriftelijk informed consent

E.4

Principal exclusion criteria

Age range < 18 years
ASA classification IV and V
Allergic reaction to planned medication in the patients’ medical history
Unregulated hypertension
Hypovolemia or hypotension (SBP <80 or MAP <50)
Sever bradycardia (heartrate < 50) and / or related bradydysrhytmias (e.g. advanced heart block)
Impaired ventricular function (EF <30%)
GFR less than 15ml/min or undergoing hemodialysis
End stage liver disease
Substance abuse

Leeftijd <18 jaar
ASA classificatie IV en V
Allergische reactie op de geplande medicatie in medische patiënten voorgeschiedenis
Ongereguleerde hypertensie
Hypovolemie of hypotensie (SBP <80 of MAP <50)
Bradycardie (hartfrequentie <50) en / of verwante
Verminderde ventriculaire functie (EF <30%)
GFR minder dan 15ml/min of hemodialyse
Eindstadium leverziekte
Drugsmisbruik

E.5 End points

E.5.1

Primary end point(s)

Main study parameters are the experiences (e.g. satisfaction levels reached) made by patients and gastroenterologist during sedation. We will also measure sweat production by a sweat conduction monitor as a mark for patients stress level during endoscopy.

Eindpunten zijn de ondervindingen van patiënten en gastro-enterologen tijdens een esofagus interventie onder sedatie. Daarnaast wordt middels een zweet monitor het zweet productie bij de patiënt gemeten. De resultaten maken een inschatting van het stress niveau mogelijk welke de patiënt tijdens het onderzoek beleeft.

E.5.1.1

Timepoint(s) of evaluation of this end point

Satisfaction levels are measured by means of questionnaires pre- and post procedure (30min post) and in case of the patient on the following day.
Sweat conductance monitoring will be used during the procedure and recovery.

Tevredenheid wordt gemeten door middel van vragenlijsten voor en na de procedure (30min post) en in het geval van de patiënt op de volgende dag.
Zweet monitoring zal worden gebruikt tijdens de procedure en herstel periode.

E.5.2

Secondary end point(s)

Secondary study parameters include in patients measurement of oxygen saturation (SO2) measured by pulseoxymetry, exhaled CO2 (capnography), heart rate, arrhythmias (ECG) and blood pressure (non-invasive blood pressure measurement, NIBP). These parameters are surrogate parameters of pulmonary and cardiovascular problems, experienced by the patient during sedation.

Verdere parameters zijn saturatie metingen middels pulsoxymeter, endexpiratoire CO2, hart frequentie, aritmie en bloed druk. Deze parameters zijn surrogaatparameters voor pulmonale en kardinale aandoeningen bij de patiënt. Ze zijn daarmee afspiegelingen van het heersende veiligheidsniveau

E.5.2.1

Timepoint(s) of evaluation of this end point

Measurements take place during procedure and recovery period.

Metingen vinden plaats tijdens de procedure en de herstelperiode

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

Yes

E.6.13.1

Other scope of the trial description

satisfaction

tevredenheid

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)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

verschillende sedatie regimes

different sedation regimes

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

The trail ends one day after including the 64. patient and performing the oesophagus intervention with the interview with the last patient on phone.

De trial eindigt met het afsluitende telefoongesprek met de 64. patient op de dag nadat de oesofagus interventie bij dezelfde patiënt heeft plaatsgevonden.

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

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

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

not applicable

n.v.t.

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

2011-09-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-01-12

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-04-26

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