Clinical Trials Register

Summary
EudraCT Number:	2020-002565-34
Sponsor's Protocol Code Number:	ERACLES01/2020
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
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

2020-002565-34

A.3

Full title of the trial

Evaluation of 2 different Regimens of colon preparation for an Advanced CLEaning using a 2lt peg-cs with simethicone: a randomized, controlled Study “ERACLES01/2020”

Valutazione di due diversi regimi di preparazione intestinale per una pulizia avanzata impiegando 2 litri di peg-cs con simeticone : studio randomizzato di confronto – ERACLES01/2020

A.3.1

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

Evaluation of 2 regimens of colon preparation for advanced cleaning.

Valutazione di 2 regimi di preparazione intestinale per pulizia avanzata.

A.3.2

Name or abbreviated title of the trial where available

ERACLES

A.4.1

Sponsor's protocol code number

ERACLES01/2020

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	SOCIETA' ITALIANA DI ENDOSCOPIA DIGESTIVA - SIED
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	InformaPRO srl
B.5.2	Functional name of contact point	Contract Research Organization
B.5.3	Address:
B.5.3.1	Street Address	Via Guido Guinizelli 98-100
B.5.3.2	Town/ city	ROMA
B.5.3.3	Post code	00152
B.5.3.4	Country	Italy
B.5.4	Telephone number	065502218
B.5.5	Fax number	0662207168
B.5.6	E-mail	amministrazione@informa.pro

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	CLENSIA
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	CLENSIA
D.3.2	Product code	[NA]
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, Sodio solfato anidro, Simeticone, Sodio citrato, Acido citrico anidro, Sodio cloruro, Potassio cloruro
D.3.9.2	Current sponsor code	OPR000000433
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	52
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	CLENSIA
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	CLENSIA
D.3.2	Product code	[na]
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, Sodio solfato anidro, Simeticone, Sodio citrato, Acido citrico anidro, Sodio cloruro, Potassio cloruro
D.3.9.2	Current sponsor code	OPR000000433
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	52
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Macrogol 4000, Sodio solfato anidro, Simeticone, Sodio citrato, Acido citrico anidro, Sodio cloruro, Potassio cloruro
D.3.9.2	Current sponsor code	OPR000000433
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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.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

Intestinal cleaning in subjects submitted to colonscopy planned between 8:00 and 10.00 a.m..

Pulizia intestinale in soggetti sottoposti a colonscopia programmata tra le 8:00 e le 10.00 del mattino.

E.1.1.1

Medical condition in easily understood language

Intestinal cleaning in subjects submitted to colonscopy.

Pulizia intestinale in soggetti sottoposti a colonscopia.

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	10010011
E.1.2	Term	Colonoscopy normal
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

Evaluation of the efficacy of preparation A vs preparation B, in terms of colon cleaning, in paients submitted to colonscopy.

Valutazione della efficacia della preparazione A vs la preparazione B, in termini di pulizia intestinale, nei pazienti sottoposti a colonscopia

E.2.2

Secondary objectives of the trial

Evaluation of the efficacy of preparation A vs preparation B, in terms of right colon cleaning, in patients submitted to colonscopy.
Evaluation of the efficacy of preparation A vs preparation B, in terms of wounds detected, in patients submitted to colonscopy.
Evaluation of the efficacy of preparation A vs preparation B, in terms of mucosa visibility, in patients submitted to colonscopy.
Evaluation of the efficacy of preparation A vs preparation B, in terms of compliance and acceptability, in patients submitted to colonscopy.
Evaluation of the tolerability of preparation A vs preparation B in patients submitted to colonscopy.
Evaluation of the safety of preparation A vs preparation B , in terms of adverse events onset, in patients submitted to colonscopy.

Valutazione della efficacia della preparazione A vs la preparazione B, in termini di pulizia del colon destro, nei pazienti sottoposti a colonscopia
Valutazione della efficacia della preparazione A vs la preparazione B, in termini di lesioni rilevate, nei pazienti sottoposti a colonscopia
Valutazione della efficacia della preparazione A vs la preparazione B, in termini di visibilità della mucosa, nei pazienti sottoposti a colonscopia
Valutazione della efficacia della preparazione A vs la preparazione B in termini di compliance e accettabilità, nei pazienti sottoposti a colonscopia
Valutazione della tollerabilità gastrointestinale della preparazione A vs la preparazione B, nei pazienti sottoposti a colonscopia .
Valutazioni della sicurezza della preparazione A vs la preparazione B, in termini di comparsa di eventi avversi, nei pazienti sottoposti a colonscopia.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Outpatients of both genders that are consecutively submitted to colonscopy with the examination planned from 8:00 to 10:00 a.m..
Age between 18 and 75 years
Written informed consent

Pazienti di sesso maschile/femminile ambulatoriali, sottoposti consecutivamente a colonscopia con esame programmato dalle ore 8.00 alle ore 10.00
Età compresa tra 18 e 75 anni
Consenso informato scritto

E.4

Principal exclusion criteria

Hypersensitivity and controindications to study product
Either history of colon resection or bowel inflammatory disease
Previous surgery of the digestive tract
Suspected bowel drilling
Either pregnacy or lactation
Treatment with drugs which can alter bowel peristalsis
Either inability or rejection to give written informed consent
Any other clinical condition which is not compatible with the participation in this study according to the investigator

Ipersensibilità e controindicazioni al prodotto in studio
Anamnesi di resezione colica o malattia infiammatoria intestinale
Pregressa chirurgia del tubo digerente
Sospetta perforazione gastrointestinale
Gravidanza o allattamento
Trattamento con farmaci in grado di alterare la peristalsi intestinale
Incapacità o rifiuto di fornire il consenso informato scritto
Qualsiasi altra condizione clinica non giudicata compatibile con la partecipazione allo studio presente, da parte del medico sperimentatore

E.5 End points

E.5.1

Primary end point(s)

Percentage of colonscopies with adecuate preparation (according to BBPS score = 2) in each bowel segment, in group of patients A vs group of patients B

Percentuale di colonscopie con preparazione adeguata (secondo BBPS punteggio = 2) in ciascun segmento colico, nel gruppo di pazienti A vs il gruppo di pazienti B

E.5.1.1

Timepoint(s) of evaluation of this end point

At visit 2, after the execution of colonscopy for each ptient enrolled in this study.

In occasione della Visita 2, dopo l'esecuzione della colonscopia a ciascun paziente arruolato in questo studio

E.5.2

Secondary end point(s)

Number and percentage of colonscopies with adecuate preparation (according to BBPS score = 2) in right bowel, in group of patients A vs group of patients B
Number of wounds detected in group of patients A vs group of patients B
Amount of bubbles and/or foam according to IBS in group of patients A vs group of patients B
Level of acceptatbility and compliance, through questionnaire, in group of patients A vs group of patients B
Level of tolerability, through questionnaire, in group of patients A vs group of patients B
Rate and entity of adverse events in group of patients A vs group of patients B

Numero e percentuale di colonscopie con preparazione adeguata (secondo BBPS) nel colon destro, nel gruppo di pazienti A vs il gruppo di pazienti B
Numero di lesioni rilevate , nel gruppo di pazienti A vs il gruppo di pazienti B
Quantità di bolle e/o schiuma secondo IBS, nel gruppo di pazienti A vs il gruppo di pazienti B
Grado di accettabilità e compliance, mediante questionario, nel gruppo di pazienti A vs il gruppo di pazienti B
Grado di tollerabilità, mediante questionario, nel gruppo di pazienti A vs il gruppo di pazienti B
Tasso di comparsa e dell’entità degli eventi avversi, nel gruppo di pazienti A vs il gruppo di pazienti B

E.5.2.1

Timepoint(s) of evaluation of this end point

At visit 2, after the execution of colonscopy for each ptient enrolled in this study.

In occasione della Visita 2, dopo l'esecuzione della colonscopia a ciascun paziente arruolato in questo studio

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

Yes

E.8.1.3

Single blind

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Stesso farmaco con regime di somministrazione in 2 giorni consecutivi

Same drug with administration during 2 consecutive days

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

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:

160

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

160

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

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

320

F.4.2

For a multinational trial

F.4.2.1

In the EEA

320

F.4.2.2

In the whole clinical trial

320

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)

At the end of the study the patients will be followed at each centre according to the clinical assistance criteria foreseen.

Al termine della sperimentazione i pazienti saranno seguiti presso ciascun centro in accordo ai criteri di assistenza clinica previsti.

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

2021-02-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-12-28

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