Clinical Trials Register

Summary
EudraCT Number:	2020-000927-38
Sponsor's Protocol Code Number:	PLATONEv1.0.2020
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:	2021-06-04
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

2020-000927-38

A.3

Full title of the trial

Bowel preparation with either novel 1L PEG+Asc or 2L PEG+Asc solution: a multicenter, randomized study in elderly outpatients: the PLATONE Study.

Preparazione intestinale per colonscopia con una nuova soluzione (1L) PEG + Asc o (2L) PEG + Asc: uno studio multicentrico e randomizzato su pazienti ambulatoriali anziani: lo studio PLATONE.

A.3.1

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

Comparison between two bowel preparations (laxatives) of different volume in elderly people

Confronto fra due schemi di preparazione intestinale per colonscopia (lassativi) a diverso volume in popolazione anziana.

A.3.2

Name or abbreviated title of the trial where available

PLATONE (PLenvu Aigo TO Non-hospitalized Elderly)

A.4.1

Sponsor's protocol code number

PLATONEv1.0.2020

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	AIGO - Associazione Italiana Gastroenterologi ed Endoscopisti DIgestivi Ospedalieri
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 srl
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	Azienda USL Toscana Centro
B.5.2	Functional name of contact point	S.O.C. Gastroenterologia Pistoia
B.5.3	Address:
B.5.3.1	Street Address	P.O. Ss. Cosma e Damiano - Via Battisti 2
B.5.3.2	Town/ city	Pescia
B.5.3.3	Post code	51017
B.5.3.4	Country	Italy
B.5.4	Telephone number	0572460582
B.5.5	Fax number	0572460541
B.5.6	E-mail	paolo.montalto@uslcentro.toscana.it

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	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	[N.A.]
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	N.A.
D.3.9.3	Other descriptive name	PEG 3350
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	140
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	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 - POLVERE PER SOLUZIONE ORALE 2 SACCHE CONTENENTI 1 BUSTINA A CARTA/LDPE/AL/LDPE DA 112 G + 1 BUSTINA B CARTA/LDPE/AL/LDPE DA 11 G (1 TRATTAMENTO)
D.2.1.1.2	Name of the Marketing Authorisation holder	NORGINE BV
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	MOVIPREP
D.3.2	Product code	[n.a.]
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	n.a.
D.3.10	Strength
D.3.10.1	Concentration unit	g/l gram(s)/litre
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	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

Bowel preparation for diagnostic / operative colonscopy in outpatient

PREPARAZIONE INTESTINALE PER COLONSCOPIA DIAGNOSTICA/OPERATIVA IN PAZIENTI AMBULATORIALI

E.1.1.1

Medical condition in easily understood language

Bowel preparation (osmotic laxatives) in elderly adult outpatients, undergoing scheduled colonoscopy because of gastrointestinal symptoms, Screening, or post polypectomy surveillance

Preparazione intestinale (lassativi osmotici) in pazienti ambulatoriali anziani per colonscopia programmata per sintomi gastrointestinali, screening oncologico, e sorveglianza post-polipectomia.

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

To demonstrate that the overall bowel cleansing (Boston Bowel Preparation Scale – BBPS =6) success rate of 1L volume of Polyethylene glycol PEG 3350, Sodium Ascorbate, Sodium Sulfate (IMP Test) is not lower than that obtained using 2 l PEG+Asc (IMP Confronto), both in split dose, in elderly outpatients undergoing scheduled colonoscopy.

Dimostrare la non inferiorità (-10% limite di confidenza, LCL) in termini di toelette intestinale adeguata (Boston Bowel Preparation Scale – BBPS =6) fra una preparazione intestinale di recente introduzione in commercio (basso volume: totale: 1 lt) con PoliEtilenGlicole PEG 3350, Sodium Ascorbate, Sodium Sulfate (IMP Test) e una preparazione standard (volume totale: 2 lt) PEG+Asc (IMP Confronto), entrambe somministrate in “split dose”, in pazienti anziani sottoposti a colonscopia in regime ambulatoriale.

E.2.2

Secondary objectives of the trial

Secondary Endpoints are aimed to compare Plenvu vs Moviprep in terms of:
• Colonoscopy performance indicators (points 1-2)
• Cleansing performance on the right colon (point 3)
• Evaluate the impact of the bowel preparation’s timing on the cleansing success(point 4)
• Compliance, Tolerability and side effects assessed by patient reported outcome (points 5-10)

1) Cecal intubation rate, 2) ADR and PDR, 3) Adequate cleansing of right colon, 4) Differences in successful bowel cleansing between patients undergoing colonoscopy in the morning or in the afternoon, 5)Compliance with product intake, 6-7)Tolerability: a) first colonoscopy b) previous colonoscopy, 8) Intensity and rate of side effects, 9) Sleep quality, 10) Fecal incontinence during travel, 11) Willingness to repeat same prep in patients with previous colonscopy during the last 3 years

Obiettivi secondari sono quelli di confrontare Plenvu vs Moviprep in termini di:
- Indicatori di performance endoscopica (parametri 1-2)
- Pulizia colon destro (parametro 3)
- differenze nella preparazione a seconda del momento della preparazione (parametro 4)
- Compliance, tollerabilità, effetti collaterali riportati dal paziente (parametri 5-10)

1) percentuale raggiungimento del ceco, 2) Adenoma Detection Rate, 3) Percentuale dei pazienti con pulizia adeguata del colon destro, 4) differenze di risultato fra pazienti che eseguono colonscopia al mattino o al pomeriggio, 5) compliance con l’assunzione del prodotto, 6) tollerabilità del prodotto, 7) confronto con precedente preparazione (se già eseguita in passato), 8) effetti collaterali, 9) qualità del sonno, 10) incontinenza fecale durante il tragitto per l’ospedale, 11) volontà di ripetere lo stesso schema di preparazione in pazienti che avevano già eseguito preparazione in precedenza.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Participants eligible for inclusion in the study will be adult outpatients aged between 65 and 85 years undergoing scheduled elective colonoscopy in a hospital setting for indications including evaluation of gastrointestinal (GI) symptoms, screening, and polyp surveillance.
Patients must provide written informed consent, and must be able to understand and comply with the instructions and to complete the entire study,

pazienti ambulatoriali adulti di età compresa tra 65 e 85 anni, afferenti al centro per colonscopia programmata in elezione per valutazione sintomi gastrointestinali, screening, e sorveglianza pregresse polipectomie.
I pazienti devono fornire il consenso informato scritto ed essere in grado di capire e di completare l'intero studio rispettando le istruzioni

E.4

Principal exclusion criteria

Patients will be excluded in case of: GI obstruction; toxic megacolon, or active GI bleeding; severe constipation (with regular use of laxatives – 2-3 times per week in the last month); previous history of colorectal resection; acute exacerbation of inflammatory bowel disease; liver cirrhosis with ascites (Child Pugh B or C); impaired renal function (eGFR<30 ml/min/1.73 m2); congestive heart failure (NYHA Class III - IV); cognitive impairment; phenylketonuria; G6PDH deficiency; active treatment for cardiovascular disease or ECG changes in the last 12 months (for example arrhythmias); thyroid disease, or electrolytic imbalance; treatment resistant hypertension (systolic BP =140 mm Hg; diastolic BP=90 mm Hg ); hypersensitivity or known allergy to PEG (or to any of the listed components), and generally according to contraindications, special warnings and precautions for use respective of both products; previous participation in a clinical trial with administration of investigational drug within 30 days or 5-half lives of the study drug.

i pazienti verranno esclusi in presenza di ostruzione gastrointestinale; megacolon tossico o sanguinamento digestivo attivo stipsi grave (con regolare uso di lassativi almeno 2-3 volte per settimana nell'ultimo mese), pregressa resezione chirurgica colon, riacutizzazione IBD, cirrosi epatica in fase ascitica (Child Pugh B o C), insufficienza renale severa (eGFR<30 ml/min/1.73 m2), scompenso cardiaco congestizio (Classe NYHA III-IV), anamnesi pregressa negli ultimi 12 mesi o evidenza di alterazioni elettrocardiografiche indicative di patologie in atto (ad esempio, aritmie).decadimento cognitivo, allergia/controindicazioni all’uso di PEG, deficit G6PDH, fenichetonuria, soggetti in trattamento per malattie cardiovascolari, malattie della tiroide o squilibrio elettrolitico, anamnesi di ipertensione non controllata con pressione sistolica > 140 mmHg e pressione diastolica > 90 mmHg. ipersensibilità ai principi attivi o ad uno qualsiasi degli eccipienti elencati, partecipazione ad uno studio clinico in cui sia stato somministrato un farmaco sperimentale entro 30 giorni o 5 emivite del farmaco in studio

E.5 End points

E.5.1

Primary end point(s)

see above

vedi sopra

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

E.5.2

Secondary end point(s)

see above

vedi sopra

E.5.2.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

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

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

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)

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

500

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

500

F.4.2

For a multinational trial

F.4.2.1

In the EEA

500

F.4.2.2

In the whole clinical trial

500

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)

hospital discharge after colonoscopy as usual routine for the centre.

dimissione ambulatoriale dopo colonscopia programmata in elezione secondo le procedure abituali del centro

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

2021-04-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-07-27

P. End of Trial
P.	End of Trial Status	Completed

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