Clinical Trials Register

Summary
EudraCT Number:	2019-002799-15
Sponsor's Protocol Code Number:	INTERPRET
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-05-24
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-002799-15

A.3

Full title of the trial

Efficacy of a very low-volume Polyethylene Glycole (PEG 1L) bowel preparation vs. low-volume (2L) and high-volume (4L) PEG-based preparations. A randomized controlled study.

Efficacia di una preparazione intestinale per la colonscopia a bassissimo volume a base di polietilenglicole (PEG 1L) vs. preparazioni a basso (2L) ed alto (4L) volume a base di PEG nel paziente ricoverato. Studio randomizzato controllato.

A.3.1

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

Randomized controlled study to assess the efficacy of a very low-volume Polyethylene Glycole (PEG 1L) bowel preparation vs. low-volume (2L) and high-volume (4L) PEG-based preparations, among patients who undergo bowel purge for colonoscopy during in hospital stay.

Studio randomizzato controllato per la valutazione dell’efficacia di una preparazione intestinale a bassissimo volume a base di polietilenglicole (PEG 1L) vs. preparazioni a basso (2L) ed alto (4L) volume a base di PEG nei pazienti sottoposti alla preparazione per la colonscopia in regime di ricovero.

A.3.2

Name or abbreviated title of the trial where available

INpatienTs bowEl pReParation RandomizEd Trial

INTERPRET

A.4.1

Sponsor's protocol code number

INTERPRET

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	ALMA MATER STUDIORUM UNIVERSITà DI BOLOGNA
B.1.3.4	Country	Italy
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Alma Mater Studiorum Università di Bologna
B.5.2	Functional name of contact point	Dipartimento di Scienze Mediche e C
B.5.3	Address:
B.5.3.1	Street Address	Via Massarenti 9
B.5.3.2	Town/ city	Bologna
B.5.3.3	Post code	40138
B.5.3.4	Country	Italy
B.5.6	E-mail	lorenzo.fuccio3@unibo.it

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	MOVIPREP
D.2.1.1.2	Name of the Marketing Authorisation holder	NORGINE BV
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	MOVIPREP
D.3.2	Product code	[037711]
D.3.4	Pharmaceutical form	Powder for oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Glicole polietilenico
D.3.9.1	CAS number	107-21-1
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	200
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodio solfato
D.3.9.1	CAS number	7757-82-6
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Acido ascorbico
D.3.9.1	CAS number	50-81-7
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	9
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ascorbato di sodio
D.3.9.1	CAS number	134-03-2
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	11
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	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	PLENVU - POLVERE PER SOLUZIONE ORALE 1 BUSTINA PET/PE/AL DA 115,96 G + 1 BUSTINA A PET/PE/AL DA 46,26 G + 1 BUSTINA B PET/PE/AL DA 55,65 G (1 TRATTAMENTO)
D.2.1.1.2	Name of the Marketing Authorisation holder	NORGINE ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	PLENVU
D.3.2	Product code	[045671]
D.3.4	Pharmaceutical form	Powder for oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	glicole polietilenico
D.3.9.1	CAS number	107-21-1
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	140
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	solfato di sodio
D.3.9.1	CAS number	7757-82-6
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	9
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ascorbato di sodio
D.3.9.1	CAS number	134-03-2
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	48
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	acido L-ascorbico
D.3.9.1	CAS number	50-81-7
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	7
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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	SELG ESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	Alfasigma S.p.A
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	SELG ESSE
D.3.2	Product code	[029121]
D.3.4	Pharmaceutical form	Powder for oral solution
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	macrogol 4000
D.3.9.1	CAS number	107-21-1
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	70
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	simeticone
D.3.9.1	CAS number	8050-81-5
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	1
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sodio solfato
D.3.9.1	CAS number	7757-82-6
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sodio bicarbonato
D.3.9.1	CAS number	144-55-8
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	1X 100 milligrams/millilitre
D.3.10.2	Concentration type	not less then
D.3.10.3	Concentration number	1
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Adult in hospital patients who undergo colonoscopy for any medical disease

Pazienti ricoverati maggiorenni candidati a colonscopia in regime di ricovero per qualsiasi patologia

E.1.1.1

Medical condition in easily understood language

Adult in hospital patients who undergo colonoscopy for any medical disease

Pazienti ricoverati maggiorenni candidati a colonscopia in regime di ricovero per qualsiasi patologia

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	PT
E.1.2	Classification code	10010007
E.1.2	Term	Colonoscopy
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

To assess the efficacy of a very low volume (1L) bowel preparation containing polyethilenglycole(PEG)+ascorbate(Asc) vs. low (2L) and high (4L) volume bowel preparations, in hospitalized patients

Valutare e confrontare la efficacia di una nuova preparazione a bassissimo volume (1L) a base di polietilenglicole(PEG)+ascorbato(Asc) vs. preparazioni a base di PEG a basso (2L) ed alto (4L) volume attualmente in uso, nel setting dei pazienti ricoverati.

E.2.2

Secondary objectives of the trial

To evaluate adherence to bowel preparations, in terms of percentage of intake.
To evaluate tolerability to bowel preparations (nausea, vomiting, abdominal pain, flatulence, taste).
To evaluate safety of bowel preparations.
To evaluate the percentage of patients who are rescheduled to colonoscopy due to inadequate cleansing.
To validate a recently-developed predictive model of cleansing

Valutare l'aderenza, intesa come percentuale di volume assunto della preparazione intestinale.
Valutare la tollerabilità della preparazione intestinale (nausea, vomito, dolore addominale, meteorismo, palatabilità della preparazione).
Valutare la sicurezza dei 3 tipi di preparazione intestinale.
Valutare la percentuale dei pazienti che vengono riprogrammati a nuova colonscopia per toilette intestinale inadeguata.
Validare un modello predittivo per toilette intestinale adeguata recentemente sviluppato

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Adult in hospital patients who are scheduled for colonoscopy due to any medical disease, provided that written consent is obtained

Pazienti ricoverati maggiorenni candidati a colonscopia in regime di ricovero per qualsiasi patologia, previo ottenimento di consenso informato.

E.4

Principal exclusion criteria

• Previous colonic surgery
• Bowel obstruction, delayed gastric emptying, bowel perforation, toxic megacolon
• Phenylketonuria
• Glucose-6-phosphate dehydrogenase deficiency
• Acute gastrointestinal bleeding
• Emergency colonoscopy
• Dementia or other diseases requiring administration of bowel preparations via naso-gastric tube
• Patients with “Controindications” to bowel preparations as reported in the relevant summary of product characteristics

• Resezione colica pregressa
• occlusione intestinale, ostacolato svuotamento gastrico, perforazione intestinale, megacolon tossico
• fenilchetonuria
• deficit di glucosio-6-fosfato deidrogenasi
• sanguinamento gastrointestinale acuto
• colonscopia in regime di emergenza
• Demenza o altra patologia che richieda la somministrazione della preparazione tramite SNG
• Pazienti che presentino patologie o condizioni riportate nella sezione “Controindicazioni” riportata nella scheda tecniche dei farmaci utilizzati (i.e. ipersensibilità ai principi attivi)

E.5 End points

E.5.1

Primary end point(s)

Cleansing will be evaluated according to the Boston Bowel Preparation Scale (BBPS), which assigned a score from 0 (presence of solid stools) to 3 (excellent visualization of colonic mucosa) for each main colonic tracts, i.e. right colon, transverse colon and left colon/rectum. Cleansing will be asessed as inadequate in case of total score <6 or <2 in one tract [Lai, 2009].

La pulizia intestinale verrà valutata sec. la Boston Bowel Preparation Scale (BBPS), che attribuisce un punteggio da 0 (presenza di feci solide) a 3 (ottima visualizzazione della mucosa colica) per ciascuno dei tre segmenti principali del colon, i.e. colon destro, colon trasverso e colon sinistro-retto. La pulizia intestinale sarà giudicata inadeguata in caso di punteggio totale <6 oppure di punteggio <2 anche in uno solo dei segmenti colici [Lai, 2009].

E.5.1.1

Timepoint(s) of evaluation of this end point

During the execution of colonoscopy

Durante l'esecuzione della colonscopia

E.5.2

Secondary end point(s)

Adherence, in terms of percentage of bowel preparation intake, will be evaluated using a 5-point scale, based on the following percentages of intake: 1, 0-25%; 2, 26-50%; 3, 51-75%; 4, 76-90%; 5, 91-100%.; Tolerability of bowle preparations will be evaluated using a 4-point scale (1=worst; 4=excellent) for each outcome.; Safety will be evaluated through identification of adverse drug reactions

Aderenza al trattamento, in termini di percentuale di volume assunto della preparazione intestinale, sarà valutata secondo una scala a 5 gradi basata sulla percentuale di soluzione assunta: 1, 0-25%; 2, 26-50%; 3, 51-75%; 4, 76-90%; 5, 91-100%.; La tollerabilità della preparazione intestinale sarà valutata secondo una scala a 4 gradi (1=pessima tollerabilità; 4=massima tollerabilità) per ogni outcome.; La sicurezza dei farmaci in studio sarà valutata tramite la registrazione di eventuali reazioni avverse

E.5.2.1

Timepoint(s) of evaluation of this end point

During the execution of colonoscopy; During the execution of colonoscopy; During the execution of colonoscopy

Durante l'esecuzione della colonscopia; Durante l'esecuzione della colonscopia; Durante l'esecuzione della colonscopia

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

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

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

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)

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

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

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

Information not present in EudraCT

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

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 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:

400

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

400

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

800

F.4.2

For a multinational trial

F.4.2.1

In the EEA

800

F.4.2.2

In the whole clinical trial

800

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 will be evaluated only during a single colonoscopy, in the hospital. At the end of the procedure, the following parameters will be evaluated/collected:
- orthostatic blood pressure, heart rate and body temperature.
- clinical assessment.
- drug administration during colonoscopy, including IV fluids.
- adverse event reporting.

Il contatto con il paziente si limiterà ad una sola visita (colonscopia) in corso di degenza. Al termine della procedura colonscopica sarà eseguito/valutato quanto segue:
- Misurazione di pressione sanguigna ortostatica, frequenza cardiaca e temperatura corporea.
- Esame obiettivo.
- La documentazione dei farmaci concomitanti dovrà includere i farmaci e/o i liquidi assunti per via endovenosa durante la colonscopia.
- Registrazione di eventuali eventi avversi.

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

2020-03-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-09-16

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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