Clinical Trials Register

Summary
EudraCT Number:	2012-001680-72
Sponsor's Protocol Code Number:	TAK-390MR_206
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:	2012-10-17
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

2012-001680-72

A.3

Full title of the trial

A Phase 2 Open-Label, Multicenter, 4-Week Study to Assess the safety and
Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-
Release Capsules for Relief of Heartburn, in Adolescent subjects Aged 12 to
17 Years With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

studio multicentrico di 4 settimane in aperto, di fase II, per valutare la sicurezza e l’efficacia della somministrazione orale giornaliera delle capsule di dexlansoprazolo a rilascio prolungato per il trattamento del bruciore di stomaco in soggetti adolescenti di età compresa tra 12 e 17 anni affetti da malattia da reflusso gastroesofageo sintomatica non erosiva

A.3.1

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

4 week study to assess safety and effectiveness of Dexlansoprazole
capsules for relief of heartburn in subjects aged 12-17 with symptomatic
acid reflux disease.

studio di 4 settimane per valutare la sicurezza e l'efficacia di dexlansoprazolo in capsule per il trattamento del bruciore di stomaco in soggetti di età compresa tra i 12 e i 17 anni affetti da malattia da reflusso gastroesofageo sintomatica.

A.4.1

Sponsor's protocol code number

TAK-390MR_206

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	TAKEDA EUROPE RESEARCH & DEVELOPMENT CENTRE LTD
B.1.3.4	Country	United Kingdom
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	Takeda Global Research & Development Centre (Europe)
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Takeda Global Research & Development Centre (Europe) Ltd.
B.5.2	Functional name of contact point	Program Manager
B.5.3	Address:
B.5.3.1	Street Address	61 Aldwych
B.5.3.2	Town/ city	London
B.5.3.3	Post code	WC2B 4AE
B.5.3.4	Country	United Kingdom
B.5.4	Telephone number	0044 020 3116 8000
B.5.5	Fax number	0044 020 3116 8199
B.5.6	E-mail	clinicaloperations@tgrd.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	Dexlansoprazolo
D.2.1.1.2	Name of the Marketing Authorisation holder	Takeda Pharmaceuticals U.S.A.,
D.2.1.2	Country which granted the Marketing Authorisation	United States
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
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	Dexlansoprazolo
D.3.9.1	CAS number	138530-94-6
D.3.9.2	Current sponsor code	TAK-390
D.3.9.4	EV Substance Code	SUB31929
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	30
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

Heartburn in Adolescent subjects With Symptomatic Non-Erosive Gastroesophageal Reflux Disease

Bruciore di stomaco in soggetti adolescenti di età compresa tra 12 e 17 anni affetti da malattia da reflusso gastroesofageo sintomatica non erosiva

E.1.1.1

Medical condition in easily understood language

Heartburn in Adolescent Subjects With Acid Reflux Disease

Bruciore di stomaco in soggetti adolescenti affetti da malattia da reflusso gastroesofageo

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	LLT
E.1.2	Classification code	10018203
E.1.2	Term	GERD
E.1.2	System Organ Class	100000004856

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	10042079
E.1.2	Term	Stomach burning sensation of
E.1.2	System Organ Class	100000004856

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 assess the safety and effectiveness of treatment with once daily oral administration of dexlansoprazole delayed-release capsules (30 mg) in adolescent subjects aged 12 to 17 years, with symptomatic non-erosive GERD.

valutare la sicurezza e l’efficacia del trattamento con monosomministrazione giornaliera orale di capsule di dexlansoprazolo a rilascio prolungato (30 mg) in soggetti adolescenti di età compresa tra i 12 e i 17 anni affetti da malattia da GERD sintomatica non erosiva.

E.2.2

Secondary objectives of the trial

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

The subjects must be aged between 12 and 17 years (inclusive) and have a history of symptoms of gastroesophageal reflux disease (GERD) at least 3 months prior to screening, based on assessments of the investigator. To be enrolled in the study, patients must have heartburn for at least 3 days out of 7 during the screening period, bringing in the daily electronic diary.

I soggetti devono avere un’età compresa tra i 12 e i 17 anni (compresi) e avere un’anamnesi di sintomi di malattia da reflusso gastroesofageo (GERD) di almeno 3 mesi precedenti allo screening, in base alle valutazioni dello sperimentatore. Per essere arruolati allo studio, i pazienti devono avere bruciori di stomaco per almeno 3 giorni su 7 durante il periodo di screening, riportandolo nel diario quotidiano elettronico.

E.4

Principal exclusion criteria

patients with erosive esophagitis. Subjects with a history of hypersensitivity or allergic to dexlansoprazolo, any of its components, antacids or any proton pump inhibitor (PPI) (including lansoprazole, omeprazole, rabeprazole, pantoprazole and esomeprazole). Subjects who show evidence of cardiovascular, pulmonary, central nervous system, liver, hematopoietic, renal, metabolic, endocrine or gastrointestinal, or with severe allergies, asthma or skin rashes suggestive of allergic origin of diseases or conditions are not controlled and significant (different from the disease under study) that could interfere with the ability to participate in the subject or potentially confuse the results of the study, or clinically important findings arising from the results of physical examination or laboratory analysis, in the opinion of the investigator. Persons who must take prescription drugs or over the counter drugs and treatments listed in the section except the protocol (Section 7.3).

Soggetti affetti da esofagite erosiva. Soggetti con una storia di ipersensibilità o di allergie nei confronti di dexlansoprazolo, di qualsiasi dei suoi componenti, di antiacidi o di qualsiasi inibitore di pompa protonica (PPI) (compresi lansoprazolo, omeprazolo, rabeprazolo, pantoprazolo o esomeprazolo). Soggetti che mostrano evidenze di malattie cardiovascolari, polmonari, del sistema nervoso centrale, epatiche, ematopoietiche, renali, metaboliche, endocrine o gastrointestinali, oppure affetti da gravi allergie, asma o eruzioni cutanee di origine allergica suggestive di patologie o condizioni non controllate e significative (diverse dalla patologia in studio), che potrebbero interferire con la capacità di partecipazione del soggetto o confondere potenzialmente i risultati dello studio oppure delle scoperte clinicamente importanti derivanti dall’esame obiettivo o dai risultati delle analisi di laboratorio, secondo il giudizio dello sperimentatore. Soggetti che devono assumere farmaci su prescrizione o da banco elencati nella sezione Farmaci e trattamenti esclusi del protocollo (Sezione 7.3).

E.5 End points

E.5.1

Primary end point(s)

Treatment-emergent adverse events (TEAE) experienced by ≥5% of subjects while receiving dexlansoprazole during the 4 week Treatment Period.

l’endpoint primario di questo studio è stabilire gli eventi avversi causati dal trattamento (treatment-emergent adverse events – TEAE) sperimentati da una percentuale ≥5% dei soggetti trattati con dexlansoprazolo nel periodo di trattamento di 4 settimane.

E.5.1.1

Timepoint(s) of evaluation of this end point

An electronic daily diary is maintained and a full examination and evaluation of end points takes place during week 4 of treatment at the final visit

E' tenuto un diario elettronico giornaliero e si svolgono un esame ed una valutazione completi dei punti finali durante la settimana 4 di trattamento all'ultima visita

E.5.2

Secondary end point(s)

The percentage of days with neither daytime nor nighttime heartburn over the 4 weeks of treatment as assessed by electronic daily diary.

L’endpoint secondario di questo studio è stabilire la percentuale di giornate in assenza di bruciori di stomaco sia diurni sia notturni durante le 4 settimane di trattamento, sulla base del diario elettronico quotidiano.

E.5.2.1

Timepoint(s) of evaluation of this end point

An electronic daily diary is maintained and a full examination and evaluation of end points takes place during week 4 of treatment at the final visit

E' tenuto un diario elettronico giornaliero e si svolgono un esame ed una valutazione completi dei punti finali durante la settimana 4 di trattamento all'ultima visita

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

Yes

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)

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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)

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

Brazil

Mexico

United States

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

Yes

F.1.1

Number of subjects for this age range:

100

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)

Yes

F.1.1.6.1

Number of subjects for this age range:

100

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

100

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)

As per protocol, the subject should be returned to the care of a physician and standard therapies as required after completion of participation in the study.

Come da protocollo, il soggetto deve essere restituito alla cura di un medico e terapie standard, come richiesto dopo il completamento della partecipazione allo studio.

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

2013-03-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-09-20

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-01-21

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