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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05267613




Registration number
NCT05267613
Ethics application status
Date submitted
31/01/2022
Date registered
4/03/2022

Titles & IDs
Public title
Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.
Scientific title
A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age
Secondary ID [1] 0 0
2023-505454-18-00
Secondary ID [2] 0 0
D9612C09998
Universal Trial Number (UTN)
Trial acronym
EE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Erosive Esophagitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Nexium 20mg
Treatment: Drugs - Nexium 10mg

Active comparator: Nexium - high dose - Arm 1 (High dose = Healing dose)

Active comparator: Nexium - Low dose - Arm 2 (Low dose = ½ healing dose)


Treatment: Drugs: Nexium 20mg
Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks.

Treatment: Drugs: Nexium 10mg
Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence / absence of Erosive Esophagitis
Timepoint [1] 0 0
Week 24 (end of 16-week maintenance phase)
Secondary outcome [1] 0 0
Presence/absence of Erosive Esophagitis
Timepoint [1] 0 0
Week 8 (end of healing phase)
Secondary outcome [2] 0 0
Percentage of days without rescue medication
Timepoint [2] 0 0
Week 8 (end of healing phase) and Week 16 (end of maintenance phase)

Eligibility
Key inclusion criteria
1. Patient must be 1 to 11 years of age
2. Patients must have a clinical history of GERD for at least 3 months before the start of study
3. For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase.
4. For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE at the 8-week endoscopy visit.
5. Patients must weigh = 10 kg.
6. Patients may be male or female.
7. All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment.
8. Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of study intervention.
9. Patient's guardian must be capable of giving signed informed consent
Minimum age
1 Year
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar
2. Significant clinical illness within 4 weeks prior to the start of treatment
3. Any conditions that are predicted to require a surgery during the study period (from the day of informed consent to the day of the last scheduled visit)
4. Previous total gastrectomy
5. Anticipated need for concomitant therapy with PPIs (except for the IMPs), H2-receptor antagonists and other drugs outlined in EC#5 after enrollment in this study
6. Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment.
7. Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product
8. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
9. Judgment by the Investigator that the patient should not participate in the study if the patient or guardian is unlikely to comply with study procedures, restrictions, and requirements
10. Previous screening, or enrollment and randomization in the present study

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
6/11/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Clayton
Recruitment hospital [2] 0 0
Research Site - North Adelaide
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
5006 - North Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Indiana
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Tennessee
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Utah
Country [10] 0 0
United States of America
State/province [10] 0 0
Wisconsin
Country [11] 0 0
Argentina
State/province [11] 0 0
Cordoba
Country [12] 0 0
Argentina
State/province [12] 0 0
Córdoba
Country [13] 0 0
Argentina
State/province [13] 0 0
Parana
Country [14] 0 0
Argentina
State/province [14] 0 0
Rosario
Country [15] 0 0
Belgium
State/province [15] 0 0
Brussels
Country [16] 0 0
Belgium
State/province [16] 0 0
Namur
Country [17] 0 0
Greece
State/province [17] 0 0
Athens
Country [18] 0 0
Greece
State/province [18] 0 0
Thessaloniki
Country [19] 0 0
Italy
State/province [19] 0 0
Messina
Country [20] 0 0
Italy
State/province [20] 0 0
Napoli
Country [21] 0 0
Italy
State/province [21] 0 0
Roma
Country [22] 0 0
Lithuania
State/province [22] 0 0
Kaunas
Country [23] 0 0
Lithuania
State/province [23] 0 0
Vilnius
Country [24] 0 0
Portugal
State/province [24] 0 0
Braga
Country [25] 0 0
Portugal
State/province [25] 0 0
Coimbra
Country [26] 0 0
Portugal
State/province [26] 0 0
Lisboa
Country [27] 0 0
Portugal
State/province [27] 0 0
Porto
Country [28] 0 0
Portugal
State/province [28] 0 0
Viana do Castelo
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Novosibirsk
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Pyatigorsk
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Saint Petersburg
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Saint-Petersburg
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Tomsk
Country [34] 0 0
Spain
State/province [34] 0 0
Badalona
Country [35] 0 0
Spain
State/province [35] 0 0
Santiago de Compostela
Country [36] 0 0
Spain
State/province [36] 0 0
Sevilla
Country [37] 0 0
Vietnam
State/province [37] 0 0
Ha Noi
Country [38] 0 0
Vietnam
State/province [38] 0 0
Hanoi
Country [39] 0 0
Vietnam
State/province [39] 0 0
Hochiminh

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
IQVIA RDS Inc.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Calyx
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Commercial sector/industry
Name [3] 0 0
Laboratory Corporation of America
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Medidata Solutions
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Commercial sector/industry
Name [5] 0 0
Thermo Fisher Scientific, Inc
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
CISCRP (Center for Information and Study on Clinical Research Participation)
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Quipment Inc.
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Little Journey Ltd.
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05267613