Clinical Trials Register

Summary
EudraCT Number:	2018-000213-20
Sponsor's Protocol Code Number:	D961WC00001
Clinical Trial Type:	Outside EU/EEA
Date on which this record was first entered in the EudraCT database:	2023-06-06
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
H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED

Expand All Collapse All

A. Protocol Information

A.2

EudraCT number

2018-000213-20

A.3

Full title of the trial

An Open Label, Parallel Group, Multi-centre, Phase III Study to Assess the Efficacy and Safety of D961H for the Maintenance Therapy Following Initial Treatment in Japanese Paediatric Patients with Reflux Esophagitis and for the Prevention of Recurrence of Gastric Ulcer or Duodenal Ulcer in Japanese Paediatric Patients Treated with Non-steroidal Anti-inflammatory Drugs or Low-dose Aspirin

A.3.1

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

A Phase 3 study of D961H in Japanease Paediatric Patients with Reflux Esophagitis, Gastric Ulcer or Duodenal Ulcer

A.4.1

Sponsor's protocol code number

D961WC00001

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	Astrazeneca K.K.
B.1.3.4	Country	Japan
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 K.K.
B.4.2	Country	Japan
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Astrazeneca K.K.
B.5.2	Functional name of contact point	Clinical Operations Division, R&D
B.5.3	Address:
B.5.3.1	Street Address	3-1, Ofuka-cho, Kita-ku
B.5.3.2	Town/ city	Osaka
B.5.3.3	Post code	530-0011
B.5.3.4	Country	Japan
B.5.6	E-mail	Kazuhiko.Motono@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	NEXIUM
D.2.1.1.2	Name of the Marketing Authorisation holder	Astrazeneca
D.2.1.2	Country which granted the Marketing Authorisation	Japan
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	NEXIUM
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.3.11 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.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	NEXIUM
D.2.1.1.2	Name of the Marketing Authorisation holder	Astrazeneca
D.2.1.2	Country which granted the Marketing Authorisation	Japan
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	NEXIUM
D.3.4	Pharmaceutical form	Granules for oral suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
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

Reflux esophagitis in Japanese paediatric patients
Past gastric ulcer or duodenal ulcer in Japanese paediatric patients

E.1.1.1

Medical condition in easily understood language

Maintenance therapy in pediatric patients with reflux esophagitis.
Prevention of gastric or duodenal ulcer in pediatric patients who have non-steroidal anti-inflammatory drugs or low-dose aspirin.

E.1.1.2

Therapeutic area

Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10038262
E.1.2	Term	Reflux esophagitis
E.1.2	System Organ Class	100000004856

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10036904
E.1.2	Term	Prophylaxis of NSAID gastric ulceration
E.1.2	System Organ Class	100000004865

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10013858
E.1.2	Term	Duodenal ulcer, unspecified as acute or chronic, without mention of haemorrhage or perforation
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

Maintenance therapy for healed RE study part:
• To assess the efficacy and safety of once-daily oral administration of D961H for the maintenance of RE healing in Japanese paediatric patients aged 1 to 14 years that have symptomatically healed RE (defined as no more than mild RE-related symptoms) and if esophagogastroduodenoscopy (EGD) is done, no visible mucosal breaks observed.

Prevention of GU/DU recurrence associated with long term NSAIDs/LDA therapy study part:
• To assess the efficacy and safety of once-daily oral administration of D961H for the prevention of GU/DU recurrence in Japanese paediatric patients aged 1 to 14 years treated with long term NSAIDs/LDA therapy.

E.2.2

Secondary objectives of the trial

Maintenance therapy for healed RE study part:
• To assess the efficacy of once-daily oral administration of D961H for the maintenance of symptomatically healed RE (defined as no more than mild RE-related symptoms) and if EGD is done, no visible mucosal breaks observed, for 8 to 52 weeks for subjects who continued the study treatment after Week 32.

Prevention of GU/DU recurrence associated with long term NSAIDs/LDA therapy study part:
• To assess the efficacy of once-daily oral administration of D961H for the prevention of GU/DU recurrence for 0 to 52 weeks for subjects who continued the study treatment after Week 32.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

・Provision of signed written informed consent from the patient’s guardian (including informed consent to a genetic test) prior to conducting of any study-related procedure. Signed assent obtained from the patient as much as possible.
・Patients aged 1 to 14 years inclusive at the time of informed consent.

Maintenance therapy for healed RE study part:
・Endoscopically verified RE, Grade A or higher according to the LA classification as judged by central evaluation committee (CEC).

Prevention of GU/DU recurrence associated with long term NSAIDs/LDA therapy study part:
・Patients with documented medical history of GU or DU diagnosis based on upper gastrointestinal symptoms, fecal occult blood, EGD finding, etc.
・Expected to require a long term NSAIDs/LDA therapy (same dose is preferable) for at least 32 weeks during the study treatment.

E.4

Principal exclusion criteria

・Patients less than 10 kg in weight.
・Use of any other investigational compounds or participations in another clinical trial within 4 weeks prior to the enrolment.
・Significant clinical illness within 4 weeks prior to the informed consent, eg, unintentional weight loss, gastrointestinal bleeding requiring abstinence from food, jaundice, or any other signs indicating serious or malignant diseases.
・Presence of hepatic diseases or other conditions that could interfere with evaluation of the study as judged by investigators.
・Positive pregnancy urinary test result for post-menarcheal or lactating female patients.
・Previous total gastrectomy.
・Any conditions that are predicted to require a surgery during the study period
・History of drug addiction or alcoholism within 12 months prior to the informed consent.
・Anticipated need for concomitant therapy with any of the following after enrolment in this study*
− PPIs (except for the investigational products)
− H2-receptor antagonists
− Anticholinergic agents for gastrointestinal related diseases or symptoms
− Antacids drugs (except for magnesium oxide for constipation)
− Prostaglandin analogue indicated for peptic ulcers (eg, Misoprostol)
− Gastrointestinal promotility drugs
− Mucosal protectants
− Any drugs known to have drug-drug interactions with D961H (eg, atazanavir sulphate, rilpivirine hydrochloride, diazepam, phenytoin, cilostazol, high-dose methotrexate, warfarin, tacrolimus hydrate [except external use], digoxin, methyldigoxin, itraconazole, gefitinib, nilotinib, voriconazole, clopidogrel, nelfinavir mesilate, saquinavir mesilate, rifampicin and St. John's wort, etc.)
− Anticancer drugs (DMARD, eg, methotrexate is a “anticancer drug” that could be used for non-cancer Rheumatic disease treatment are allowed)
− Continuous therapy of NSAIDs (oral, intravenous, intramuscular, suppository more than 8 days) - for subjects enrolled in the maintenance therapy for healed RE study part only
.

E.5 End points

E.5.1

Primary end point(s)

Maintenance therapy for healed RE study part:
• Presence/absence of RE relapse from 8 to 32 weeks for all subjects by assessment of the composite endpoint (RE-related symptoms or optional EGD findings) during the maintenance therapy.
• Safety from 8 to 32 weeks for all subjects by the assessment of;
a) AEs
b) Laboratory variables
c) Vital signs

Prevention of GU/DU recurrence associated with long term NSAIDs/LDA therapy study part:
• Presence/absence of GU/DU recurrence from 0 to 32 weeks for all subjects by assessment of the composite endpoint (GU/DU-related symptoms or optional EGD findings) during the prevention therapy.
• Safety from 0 to 32 weeks for all subjects by the assessment of:
a) AEs
b) Laboratory variables
c) Vital signs

E.5.1.1

Timepoint(s) of evaluation of this end point

32 weeks

E.5.2

Secondary end point(s)

Maintenance therapy for healed RE study part:
• Presence/absence of RE relapse from 8 to 52 weeks (8 to 32 weeks and 32 to 52 weeks) for subjects who continued the study treatment after Week 32 by assessment of the composite endpoint (RE-related symptoms or optional EGD findings) during the maintenance therapy.
• Safety from 8 to 52 weeks (8 to 32 weeks and 32 to 52 weeks) for subjects who continued the study treatment after Week 32, by the assessment of;
a) AEs
b) Laboratory variables
c) Vital signs

Prevention of GU/DU recurrence associated with long term NSAIDs/LDA therapy study part:
• Presence/absence of GU/DU recurrence from 0 to 52 weeks (0 to 32 weeks and 32 to 52 weeks) for subjects who continued the study treatment after Week 32 by assessment of the composite endpoint (GU/DU-related symptoms or optional EGD findings) during the prevention therapy.
• Safety from 0 to 52 weeks (0 to 32 weeks and 32 to 52 weeks) for subjects who continued the study treatment after Week 32, by the assessment of:
a) AEs
b) Laboratory variables
c) Vital signs

E.5.2.1

Timepoint(s) of evaluation of this end point

52 weeks

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

Yes

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)

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

Will this trial be conducted at a single site globally?

E.8.4

Will this trial be conducted at multiple sites globally?

Yes

E.8.6 Trial involving sites outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Yes

E.8.6.3

Specify the countries outside of the EEA in which trial sites are planned

Japan

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

LSLV

E.8.9 Initial estimate of the duration of the trial

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:

F.1.1.1

In Utero

F.1.1.1.1

Number of subjects for this age range:

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)

Yes

F.1.1.4.1

Number of subjects for this age range:

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

The target population is 1-14years. Some children may incapable of giving consent.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

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)

None

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	Pediatric Clinical Trials Network
G.4.3.4	Network Country	Japan

H.4 Third Country in which the Trial was first authorised
H.4.1	Third Country in which the trial was first authorised:	Japan

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials