Clinical Trials Register

Summary
EudraCT Number:	2013-002428-17
Sponsor's Protocol Code Number:	2013052044
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:	2013-10-22
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

Denmark - DHMA

A.2

EudraCT number

2013-002428-17

A.3

Full title of the trial

Nurse Administered Propofol Sedation vs combined sedation with midazolam/fentanil for colonoscopy in patients with IBD. A randomised controlled trial of satisfaction and adhearence to treatment program.

Propofol- vs. standardsedation til koloskopi hos patienter med kronisk inflammatorisk tarmsygdom: Et randomiseret kontrolleret studie af tilfredshed og adherans til behandlingsprogram.

A.3.1

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

Propofol- vs. standard let bedøvelse til kikkertundersøgelse hos patienter med kronisk inflammatorisk tarmsygdom: Et randomiseret kontrolleret studie af tilfredshed og villighed til at følge behandlingsprogram.

A.3.2

Name or abbreviated title of the trial where available

Propofol vs. standard sedation for colonoscopy. A study on satisfaction

Propofol vs. standardsedation til koloskopi. Et tilfredshedsstudie

A.4.1

Sponsor's protocol code number

2013052044

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	Gastroenheden D, Herlev Hospital
B.1.3.4	Country	Denmark
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	Gastroenheden D, Herlev Hospital
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Gastroenheden D, Herlev Hospital
B.5.2	Functional name of contact point	Jeppe Thue Jensen
B.5.3	Address:
B.5.3.1	Street Address	Herlev Ringvej 75
B.5.3.2	Town/ city	Herlev
B.5.3.3	Post code	2730
B.5.3.4	Country	Denmark
B.5.4	Telephone number	004526136032
B.5.6	E-mail	jeppe.thue.jensen.01@regionh.dk

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	Propofol "B. Braun"
D.2.1.1.2	Name of the Marketing Authorisation holder	Lægemiddelstyrelsen
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.3.1	Product name	Propofol "B. Braun"
D.3.4	Pharmaceutical form	Emulsion for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent) 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.3.9.3	Other descriptive name	PROPOFOL
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	equal
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	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	Midazolam "B.Braun"
D.2.1.1.2	Name of the Marketing Authorisation holder	Lægemiddelstyrelsen
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.3.1	Product name	Midazolam "B. Braun"
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent) Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	MIDAZOLAM
D.3.9.1	CAS number	59467-70-8
D.3.9.4	EV Substance Code	SUB08950MIG
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	1
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: 3
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	Fentanyl "B. Braun"
D.2.1.1.2	Name of the Marketing Authorisation holder	Lægemiddelstyrelsen
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.3.1	Product name	Fentanyl "B. Braun"
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 bolus use (Noncurrent)
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Fentanyl
D.3.9.1	CAS number	437-38-7
D.3.9.3	Other descriptive name	FENTANYL
D.3.9.4	EV Substance Code	SUB07597MIG
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	50
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Satisfaction with sedation during colonoscopy in patients with inflammatory bowel disease

Tilfredshed med sedation under koloskopi hos patienter med inflammatorisk tarmsygdom

E.1.1.1

Medical condition in easily understood language

Satisfaction with sedation during endoscopic examination in patients with inflammatory bowel disease

Tilfredshed med letbedøvelse under kikkertundersøgelse af tyktarm hos patienter med inflammatorisk tarmsygdom

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	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10049683
E.1.2	Term	Monitored anesthesia care sedation
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

To study if patients with inflammatory bowel disease prefer sedation with propofol or midazolam/fentanyl for their colonoscopy, and if the sedation of choice can increase adherence to treatment program

At undersøge om patienter med inflammatorisk tarmsygdom foretrækker propofol eller midazolam/fentanyl som sedativ til deres koloskopi, og om typen af sedation påvirker patienternes motivation for fremadrettet at få gennemfrt koloskopi

E.2.2

Secondary objectives of the trial

If Pre-morbid psyche affects perception and satisfaction with propofol- or midazolam/fentanyl sedation

Om pre-morbid psyke påvirker tilfredsheden med propofol- eller midazolam/fentanyl sedation

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

1. The correlation between the quality of Nurse Administered Propofol Sedation and patients experience and satisfaction with sedation for colonoscopy in IBD monitoring - Does the sedation performance affect satisfaction with sedation. ei. A well conceived sedation yields satisfied patients, and visa versa.

2. Nurse Administered Propofol Sedation vs midazolam and fentanyl, sedation for colonoscopy in patients with IBD. A randomised controlled trial of feasibility of manual administration of sedation. - Is the studied regimen of manual propofol sedation by endoscopy nurses feasible in terms of timeconsumption and handling during the sedation.

1.. Korrelationen mellem kvaliteten af Nurse Administrerede Propofol Sedation og patienternes oplevelse og tilfredshed med sedationen under koloskopi ved IBD kontrol- Påvirker sedation performance tilfredshed med sedation. Dvs En veludført sedation giver tilfredse patienter, og visa versa.

2.. Sygeplejerske Administrerede Propofol Sedation vs midazolam og fentanyl, sedation under koloskopi hos patienter med IBD. En randomiseret kontrolleret forsøg af gennemførligheden af manuelt administreret sedation. - Er det undersøgte regime med manuel propofol sedation af endoskopi sygeplejersker gennemførligt i forhold til tidsforbrug og håndteringen under sedationen.

E.3

Principal inclusion criteria

1. Elective endoscopy due to IBD or suspected IBD
2. Willing to be randomised
3. Provide written informed consent

1. Skal have udført elektiv endoskopi
2. Villig til at lade sig randomisere
3. Kan udfylde skriftligt informeret samtykke

E.4

Principal exclusion criteria

1. Allergy to contents administered
2. pregnant or nursing
3. <18 years of age
4. Not able to complete questionnaire
5. Acute condition
6. severe COPD
7. > ASA II
8. Sleep apnea
9. Risk of aspiration
10. Previously difficulty with anesthesia
11. Difficult airway

1.. Allergi over for indholdsstoffer
2.. gravid eller ammende
3.. <18 år
4.. Ikke er i stand til at fuldføre spørgeskemaet
5.. akut tilstand
6.. svær KOL
7.. > ASA II
8.. søvnapnø
9.. Risiko for aspiration
10.. Tidligere problemer med anæstesi
11.. Vanskelig luftvej

E.5 End points

E.5.1

Primary end point(s)

Satisfaction score as measured by questionnaire
Quality of sedation score
Time consumption from admission to discharge
Frequency and handling of adverse events

Tilfredshedsscore målt ved spørgeskema
Kvaliteten af sedation målt ved score
Tidsforbrug fra indlæggelse til udskrivning
Frekvens og håndtering af hændelser under sedation

E.5.1.1

Timepoint(s) of evaluation of this end point

After inclusion of 200 patients.
Estimated to 14 months

Efter inklusion af 200 patienter
Forventet varighed: 14 måneder

E.5.2

Secondary end point(s)

Assessment of pre-morbid psyche
Baseline demographics
drop-out characteristics
risk Assessment
Willingness to repeat the procedure
follow-up after 6-12 months

Vurdering af pre-morbid psyke
Baseline demografi
drop-out karakteristik
Risikovurdering
Villighed til at gentage proceduren
follow-up efter 6-12 måneder

E.5.2.1

Timepoint(s) of evaluation of this end point

After inclusion of 200 patients.
Estimated to 14 months

Efter inklusion af 200 patienter
forventet at tage 14 måneder

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

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)

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

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

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

after 200 complete dataset

200 fulde dataset

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

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:

170

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

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 2013-10-22.

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

200

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
G.4 Investigator Network to be involved in the Trial: 1

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-10-04

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-08-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-09-25

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