Clinical Trials Register

Summary
EudraCT Number:	2012-001351-40
Sponsor's Protocol Code Number:	MES-CT01
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:	2012-08-07
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2012-001351-40

A.3

Full title of the trial

Azione chemiopreventiva della mesalazina sul cancro del colon-retto: studio pilota per la valutazione degli effetti molecolari 'œin vivo' sulla via di segnalazione proliferativa della catenina.

A.3.1

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

A.4.1

Sponsor's protocol code number

MES-CT01

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	SOFAR SPA
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	SOFAR SPA
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	SOFAR SPA
B.5.2	Functional name of contact point	Dipartimento Medico
B.5.3	Address:
B.5.3.1	Street Address	VIA FIRENZA, 40
B.5.3.2	Town/ city	TREZZANO ROSA
B.5.3.3	Post code	20060
B.5.3.4	Country	Italy
B.5.4	Telephone number	02 909362231
B.5.5	Fax number	02 90967239
B.5.6	E-mail	gbartesaghi@sofarfarm.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	PENTACOL 800*60CPR 800MG R.M.
D.2.1.1.2	Name of the Marketing Authorisation holder	SOFAR SpA
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.3.4	Pharmaceutical form	Modified-release tablet
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	MESALAZINE
D.3.9.1	CAS number	89-57-6
D.3.9.4	EV Substance Code	SUB08782MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	800
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

Lesioni pre-cancerose del colon-retto (adenomi) e concomitante malattia diverticolare/colite diverticolare

E.1.1.1

Medical condition in easily understood language

Lesioni pre-cancerose del colon-retto (adenomi) e concomitante malattia diverticolare/colite diverticolare

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10048832
E.1.2	Term	Colon adenoma
E.1.2	System Organ Class	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

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	10013549
E.1.2	Term	Diverticulosis
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

L’obiettivo primario dello studio è di ottenere una conferma “in vivo” dell’ipotesi formulata “in vitro” che mesalazina induca l’espressione del gene della μ-protocaderina, tramite analisi molecolare, mediante RT-PCR quantitativa, dell’espressione messaggeriale del gene codificante per la μ-protocaderina e di altri geni correlati alla via di segnalazione proliferativa della β-catenina, in biopsie di mucosa normale del colon prelevate prima e dopo trattamento dei pazienti con 5-ASA confrontate con biopsie di mucosa normale del colon prelevate all’inizio e alla fine dello studio in pazienti non trattati. Sarà valutata la variazione del segnale rispetto al basale in numero di volte.

E.2.2

Secondary objectives of the trial

Saranno inoltre valutati i seguenti parametri:- numero di siti AP (nucleotidi depurinati) ogni 100.000 paia di basi del DNA;- nanogrammi di 8-OhdG (8-idrossi-guanina) per microgrammo di DNA;-- percentuale di cellule positive per l’espressione di μ-protocaderina,Ki-67,Caspasi-3 e Istone H2AXγ.Tali parametri saranno esaminati tramite analisi molecolare del grado di ossidazione e depurinazione del DNA e analisi cromatografica della concentrazione intra-mucosa di 5-ASA,in biopsie di mucosa normale del colon prelevate prima e dopo trattamento dei pazienti con 5-ASA.Sarà inoltre valutata la sicurezza e la tollerabilità del trattamento,con riguardo ad eventi avversi,segni vitali ed esami ematochimici.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- consenso informato scritto; - età ≥ 18 anni; - donne in età fertile che fanno uso di contraccettivi; - capacità di intendere e di volere; - adeguata toilette intestinale; - paziente afferente al servizio su indicazione del curante; - lesioni precancerose del colon-retto (polipoidi e non polipoidi) asportabili endoscopicamente; - malattia diverticolare/colite diverticolare; - le lesioni asportate devono possedere caratteristiche morfologiche, istologiche e relative alla tecnica di asportazione (polipectomia/mucosectomia “en bloc” o “in più tagli”) tali da richiedere esame endoscopico di controllo in un periodo di 3 mesi dalla data di asportazione.

E.4

Principal exclusion criteria

- età inferiore a 18 anni; - ridotta capacità di intendere e di volere; - rifiuto di fornire il consenso all’indagine endoscopica ed alla gestione dei dati dello specifico studio; - terapia con aspirina (> 100 mg/die), FANS; - malattia infiammatoria cronica intestinale; - controindicazioni alla terapia con 5-ASA (IRC, nefropatie); - note reazioni allergiche e/o intolleranze cliniche al 5-ASA; - soggetti appartenenti al gruppo 4 della classificazione ASA; - donne con gravidanza accertata o pianificata o in allattamento.

E.5 End points

E.5.1

Primary end point(s)

Analisi molecolare, mediante RT-PCR quantitativa, dell’espressione messaggeriale del gene codificante per la μ-protocaderina e di altri geni correlati alla via di segnalazione proliferativa della β-catenina, in biopsie di mucosa normale del colon prelevate prima e dopo trattamento dei pazienti con 5-ASA. Sarà valutata la variazione del segnale rispetto al basale in numero di volte.

E.5.1.1

Timepoint(s) of evaluation of this end point

Prima e dopo il trattamento dei pazienti con 5-ASA

E.5.2

Secondary end point(s)

Analisi molecolare del grado di ossidazione e depurinazione del DNA e analisi cromatografica della concentrazione intra-mucosa di 5-ASA, in biopsie di mucosa normale del colon prelevate prima e dopo trattamento dei pazienti con 5-ASA.Saranno analizzati i seguenti parametri: - numero di siti AP (nucleotidi depurinati) ogni 100.000 paia di basi del DNA; - nanogrammi di 8-OhdG (8-idrossi-guanina) per microgrammo di DNA; -percentuale di cellule positive per l’espressione di μ-protocaderina, Ki-67, Caspasi-3 e Istone H2AXγ.

E.5.2.1

Timepoint(s) of evaluation of this end point

Prima e dopo il trattamento dei pazienti con 5-ASA

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

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

Yes

E.8.2.3.1

Comparator description

Nessun trattamento

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.8.4.1

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

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1

Number of subjects for this age range:

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:

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

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

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)

Terapia standard

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

2012-05-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-04-11

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

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