ICH GCP - EU Clinical trials Registry

Summary
EudraCT Number:	2011-003743-22
Sponsor's Protocol Code Number:	D9422C00001
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:	2012-03-08
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

A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-003743-22

A.3

Full title of the trial

A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Studio non comparativo, multicentrico, in aperto che ha lo scopo di valutare la sicurezza di Entocort™ EC nel trattamento del morbo di Crohn nei soggetti pediatrici di eta' tra i 5 e 17 anni compresi

A.3.1

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

A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Studio non comparativo, multicentrico, in aperto che ha lo scopo di valutare la sicurezza di Entocort™ EC nel trattamento del morbo di Crohn nei soggetti pediatrici di eta' tra i 5 e 17 anni compresi

A.4.1

Sponsor's protocol code number

D9422C00001

A.7

Trial is part of a Paediatric Investigation Plan

No

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	ASTRAZENECA
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	ASTRAZENECA
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AstraZeneca Clinical Study Information
B.5.2	Functional name of contact point	AstraZeneca Clinical Study Informat
B.5.3	Address:
B.5.3.1	Street Address	AstraZeneca Clinical Study Information
B.5.3.2	Town/ city	AstraZeneca Clinical Study Information
B.5.3.3	Post code	00000
B.5.3.4	Country	United States
B.5.4	Telephone number	001 800 236-9933
B.5.5	Fax number	001 800 236-9933
B.5.6	E-mail	information.center@astrazeneca.com

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	Entocort
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca UK Limited
D.2.1.2	Country which granted the Marketing Authorisation	United Kingdom
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	Capsule, hard
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	BUDESONIDE
D.3.9.1	CAS number	51333-22-3
D.3.9.4	EV Substance Code	SUB05955MIG
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	3
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

Crohn's Disease

Morbo di Crohn

E.1.1.1

Medical condition in easily understood language

Crohn's Disease

Morbo di Crohn

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	10011401
E.1.2	Term	Crohn's disease
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.3

Condition being studied is a rare disease

No

E.2 Objective of the trial

E.2.1

Main objective of the trial

to investigate the safety of Entocort (budesonide) in a Paediatric
population treated for mild to moderate Crohn's disease

Valutare la sicurezza di Entocort™ EC (budesonide) in una popolazione pediatrica trattata per il morbo di Crohn in forma lieve o moderata

E.2.2

Secondary objectives of the trial

To characterize the disease activity in the trial population before and
after treatment through the paediatric Crohn's Disease Activity Index
(PCDAI); Patient reported outcomes: Quality of Life with Entocort EC
treatment based on a subject questionnaire (IMPACT 3)

-Caratterizzare l’attività della malattia nella popolazione in studio attraverso l’indice pediatrico di attività del morbo di Crohn (PCDAI).
-Valutare la qualità di vita attraverso un questionario compilato dai pazienti (IMPACT 3).

E.2.3

Trial contains a sub-study

No

E.3

Principal inclusion criteria

1.All male and female subjects must be aged 5 to 17, inclusive, and must
not have reached their 18th birthday by the estimated final office visit
2.Subject must be diagnosed with active Crohn's disease of the ileum
and/or ascending colon confirmed by endoscopic and/or radiographic
evidence, and/or evidence of mucosal erosions and/or histology within
the last year
3.Subjects with mild to moderate Crohn's disease
4.All subjects must have a stool analysis negative for Clostridium
difficile, Yersinia enterolytica, Campylobacter jejuni, Salmonella,
Shigella, within the 30 days prior to visit 1
5.Alls subjects must have had laboratory assessments within 7 days
prior to visit 1

1Tutti i soggetti di sesso maschile e femminile devono avere età compresa o uguale tra 5 e 17 anni e non dovranno avere compiuto il loro 18 ° compleanno entro la data in cui è prevista la visita finale.
2Diagnosi del morbo di Crohn dell’ileo e/o del colon ascendente in fase attiva confermata da prove endoscopiche e / o esami radiografici, e/o evidenza di erosioni della mucosa e/o istologia effettuata nel corso dell'ultimo anno.
3Soggetti affetti dal morbo di Crohn in forma lieve o moderata, che necessiterebbero di un trattamento con Entocort ™ CE (ad esempio, in linea con l'indicazione per il trattamento della malattia di Crohn in forma lieve o moderata dell’ ileo e/o del colon ascendente negli adulti).
4Analisi negative, per Clostridium difficile, enterolytica Yersinia, Campylobacter jejuni, Salmonella, Shigella, entro i 30 giorni prima della Visita 1.
5Ottenimento delle valutazioni di laboratorio entro 7 giorni prima della Visita 1.

E.4

Principal exclusion criteria

1.Subjects who have had any previous intestinal resection proximal to
and including the ascending colon
2.Subjects with evidence of severe active Crohn's Disease and/or,
structuring and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications
3.Subjects who do not have a negative stool analysis, within the 30 days
prior to Visit 1
4.Subjects who have been screened/or enrolled in this study previously
within the last 6 months

1.Soggetti che hanno avuto una precedente resezione intestinale prossimale compreso il colon ascendente.
2.Soggetti con evidenza del morbo di Crohn severo attivo e / o, dilatazione stenosante e prestenotica o evidenza clinica di ostruzione, ascessi perirettali, malattia perirettale con fistole drenanti attive, perforazione, o complicanze settiche.
3.Soggetti che non presentano analisi negativa delle feci per Clostridium difficile, enterolytica Yersinia, Campylobacter jejuni, Salmonella, Shigella, entro i 30 giorni prima della Visita 1.
4.Soggetti che sono stati precedentemente screenati o arruolati in questo studio negli ultimi 6 mesi.

E.5 End points

E.5.1

Primary end point(s)

Safety measures such as adverse events, GCS-related side effects, HPAaxis measurement, laboratory test results and vital signs will be listed
and summarized descriptively, with summaries including all subjects
who received at least one dose of study treatment. Summaries will be
produced by all patients and by dose group (6 mg or 9 mg).

E.5.1.1

Timepoint(s) of evaluation of this end point

end of 8 week treatment period

al termine delle 8 settimane di trattamento

E.5.2

Secondary end point(s)

NA

E.5.2.1

Timepoint(s) of evaluation of this end point

NA

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

No

E.6.2

Prophylaxis

No

E.6.3

Therapy

No

E.6.4

Safety

Yes

E.6.5

Efficacy

No

E.6.6

Pharmacokinetic

No

E.6.7

Pharmacodynamic

No

E.6.8

Bioequivalence

No

E.6.9

Dose response

No

E.6.10

Pharmacogenetic

No

E.6.11

Pharmacogenomic

No

E.6.12

Pharmacoeconomic

No

E.6.13

Others

No

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

No

E.7.1.1

First administration to humans

No

E.7.1.2

Bioequivalence study

No

E.7.1.3

Other

No

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

No

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

No

E.8 Design of the trial

E.8.1

Controlled

No

E.8.1.1

Randomised

No

E.8.1.2

Open

Yes

E.8.1.3

Single blind

No

E.8.1.4

Double blind

No

E.8.1.5

Parallel group

No

E.8.1.6

Cross over

No

E.8.1.7

Other

No

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

E.8.2.4

Number of treatment arms in the trial

1

E.8.3

The trial involves single site in the Member State concerned

No

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

5

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

13

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

No

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Canada

United States

E.8.7

Trial has a data monitoring committee

No

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

0

E.8.9.1

In the Member State concerned months

22

E.8.9.1

In the Member State concerned days

0

E.8.9.2

In all countries concerned by the trial years

0

E.8.9.2

In all countries concerned by the trial months

26

E.8.9.2

In all countries concerned by the trial days

0

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

Yes

F.1.1

Number of subjects for this age range:

12

F.1.1.1

In Utero

No

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

No

F.1.1.3

Newborns (0-27 days)

No

F.1.1.4

Infants and toddlers (28 days-23 months)

No

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

6

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

6

F.1.2

Adults (18-64 years)

No

F.1.3

Elderly (>=65 years)

No

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

No

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

No

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

No

F.3.3.4

Nursing women

No

F.3.3.5

Emergency situation

No

F.3.3.6

Subjects incapable of giving consent personally

No

F.3.3.7

Others

No

F.4 Planned number of subjects to be included

F.4.1

In the member state

12

F.4.2

For a multinational trial

F.4.2.1

In the EEA

40

F.4.2.2

In the whole clinical trial

110

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)

NA

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

N.

Competent Authority Decision

Authorised

N.

Date of Competent Authority Decision

2011-12-01

N.

Ethics Committee Opinion of the trial application

Favourable

N.

Ethics Committee Opinion: Reason(s) for unfavourable opinion

N.

Date of Ethics Committee Opinion

2011-11-24

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-09-10

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