Clinical Trials Register

Summary
EudraCT Number:	2018-004543-24
Sponsor's Protocol Code Number:	OVER2019
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:	2020-11-06
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

2018-004543-24

A.3

Full title of the trial

Intestinal preparation with new 1 L Peg + Asc solution or with gold standard 4 L Peg in split dose. Multicenter randomized controlled trial (OVER).

Preparazione intestinale con la nuova soluzione 1 L Peg + Asc o con la standard 4 L Peg in split dose. Studio multicentrico randomizzato controllato (OVER).

A.3.1

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

Comparative study with intestinal preparation 1 L Peg + Asc with 4 L gold standard, both in split dose.

Studio di confronto con preparazione intestinale 1 L Peg+Asc con gold standard 4 L, entrambe somministrate in split dose.

A.3.2

Name or abbreviated title of the trial where available

OVER2019 (One versus four) Study

Studio OVER2019 (One versus four)

A.4.1

Sponsor's protocol code number

OVER2019

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	Provincia Religiosa di S.Pietro Ordine Ospedaliero San Giovanni di Dio Fatebenefratelli
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	Norgine Italia S.r.l.
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Ospedale Buccheri la Ferla, Fatebenefratelli
B.5.2	Functional name of contact point	Ambulatorio di endoscopia digestiva
B.5.3	Address:
B.5.3.1	Street Address	Via Messina Marine N° 197
B.5.3.2	Town/ city	Palermo
B.5.3.3	Post code	90123
B.5.3.4	Country	Italy
B.5.4	Telephone number	091479485
B.5.5	Fax number	091479385
B.5.6	E-mail	vassallorobertoblf@gmail.com

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	SELG-ESSE
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	[SELG-ESSE]
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/SODIO BICARBONATO/SODIO CLORURO/POTASSIO CLORURO/DIMETICONE
D.3.9.1	CAS number	25322-68-3
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	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	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	Yes
D.3.11.13.1	Other medicinal product type	lassativo per la preparazione intestinale per colonscopia
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	[045671017]
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 3350/SODIO SOLFATO/SODIO CLORURO/POTASSIO CLORURO/ACIDO ASCORBICO/SODIO ASCORBATO
D.3.9.1	CAS number	25322-68-3
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	Yes
D.3.11.13.1	Other medicinal product type	lassativo per la preparazione intestinale per colonscopia

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

Screening or surveillance or diagnostic colonoscopy.

Colonscopia di screening o sorveglianza o diagnostica.

E.1.1.1

Medical condition in easily understood language

The purpose of a colonoscopy is to examine the internal surface of the colon to see if polyps, tumors, ulcers or other lesions are present. To allow the endoscopist to thoroughly inspect the colon, it

Lo scopo di una colonscopia è quello di esaminare la superficie interna del colon per vedere se sono presenti polipi, tumori, ulcere o altre lesioni. Per permettere all’endoscopista di ispezionare a f

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

Evaluate the overall effectiveness of intestinal washing with 1 L Peg + Asc compared to 4 L Peg. The effectiveness of cleaning will be assessed according to the Boston scale (BBPS) by the blind endoscopist with respect to the type of preparation used. Cleanliness will be judged in case of score =6 and =2 in the individual segments

Valutare l'efficacia complessiva del lavaggio intestinale con 1 L Peg + Asc rispetto a 4 L Peg. L’efficacia della pulizia sarà valutata secondo la scala di Boston (BBPS)dall’ endoscopista in cieco rispetto al tipo di preparazione utilizzata. La pulizia sarà giudicata in caso di score =6 e =2 nei singoli segmenti

E.2.2

Secondary objectives of the trial

In the two study areas the following will be compared:
• ADR,
• PDR,
Cecal intubation rate,
• adequate cleansing in the right colon,
• complementary (taking at least 75% of each dose)
• frequency and intensity of adverse events
• willingness to repeat the same preparation (only in patients who already are
prepared in the last 24 months)
• sleep quality
• distress
• need to interrupt the journey to the center
• fecal incontinence

Nei due bracci di studio saranno confrontati:
• ADR,
• PDR,
• rate intubazione cecale,
• pulizia adeguata nel colon destro,
• compliace (assunzione di almeno 75% di ogni dose)
• frequenza e intensità di eventi avversi
• volontà di ripetere la stessa preparazione (solo nei pazienti che si sono già
sottoposti a preparazione negli ultimi 24 mesi)
• qualità del sonno
• distress
• necessità di interruzione del viaggio verso il centro
• incontinenza fecale

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients aged =18 aa and =85aa will be enrolled, who must undergo a screening, surveillance or diagnostic colonoscopy, capable of taking the preparation, without contraindications to the intake of the active ingredients of the two preparations.

Saranno arruolati pazienti di età =18 aa e =85aa, che devono sottoporsi a colonscopia di screening, di sorveglianza o diagnostica, capaci di assumere la preparazione, senza controindicazioni all’assunzione dei principi attivi delle due preparazioni.

E.4

Principal exclusion criteria

Patients under the age of 18 or over 85 years, pregnant women, patients unable to take the preparation, or with contraindications to taking the active ingredients of the two preparations

Pazienti di età inferiore a 18 anni o superiore a 85 anni, donne in gravidanza, pazienti incapaci di assumere la preparazione, o con controindicazioni all’assunzione dei principi attivi delle due preparazioni

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients with adequate cleaning (BBPS=6, single segment =2) in the 1L Peg + Asc treatment arm is no lower (lower confidence interval = -10%) than in the arm with 4L Peg treatment

Percentuale di pazienti con pulizia adeguata (BBPS=6, singolo segmento =2) nel braccio di trattamento 1L Peg+Asc è non inferiore (limite inferiore intervallo di confidenza= -10%) rispetto al braccio di trattamento 4L Peg.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 months

3 mesi

E.5.2

Secondary end point(s)

ADR, PDR, cecal intubation rate, adequate cleaning in the right colon, compliance (taking at least 75% of each dose), frequency and intensity of adverse events, willingness to repeat the same preparation (only in patients who have already undergone preparation in the last 24 months), sleep quality, distress, need to stop traveling to the center, fecal incontinence

ADR, PDR, rate intubazione cecale, pulizia adeguata nel colon destro, compliance (assunzione di almeno 75% di ogni dose) , frequenza e intensità di eventi avversi, volontà di ripetere la stessa preparazione (solo nei pazienti che si sono già sottoposti a preparazione negli ultimi 24 mesi), qualità del sonno, distress, necessità di interruzione del viaggio verso il centro, incontinenza fecale

E.5.2.1

Timepoint(s) of evaluation of this end point

3 months

3 mesi

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)

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

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 (remote follow up)

LVLS (follow up telefonico)

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 months

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:

300

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

Yes

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

400

F.4.2

For a multinational trial

F.4.2.1

In the EEA

400

F.4.2.2

In the whole clinical trial

400

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)

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

2021-01-29

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	Ongoing

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