Back to resultsStudy to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis (EE)
Primary Purpose
Erosive Esophagitis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nexium 20mg
Nexium 10mg
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Esophagitis focused on measuring Erosive Esophagitis, Gastroesophageal Reflux Disease, Healing, Maintenance, Esophagogastroduodenoscopy, Endoscopy, EGD, GERD, GERD in children
Eligibility Criteria
Inclusion Criteria:
- Patient must be 1 to 11 years of age
- Patients must have a history of GERD for at least 3 months before the start of study
- For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase.
- For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE at the 8-week endoscopy visit.
- Patients must weigh ≥ 10 kg.
- Patients may be male or female.
- All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment.
- Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of IMP treatment.
- Patient's guardian must be capable of giving signed informed consent
Exclusion Criteria:
- Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar
- Significant clinical illness within 4 weeks prior to the start of treatment
- 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)
- Previous total gastrectomy
- 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
- Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment.
- Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product
- Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
- 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
- Previous screening, or enrollment and randomization in the present study
Sites / Locations
- Research Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nexium - high dose
Nexium - Low dose
Arm Description
Arm 1 (High dose = Healing dose)
Arm 2 (Low dose = ½ healing dose)
Outcomes
Primary Outcome Measures
Presence / absence of Erosive Esophagitis
Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase
Secondary Outcome Measures
Presence/absence of Erosive Esophagitis
Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 8-week healing phase
Percentage of days without rescue medication
The percentage of days without rescue medication during the 8-week healing phase and during the 16-week maintenance phase
Full Information
NCT ID
NCT05267613
First Posted
January 31, 2022
Last Updated
September 20, 2023
Sponsor
AstraZeneca
Collaborators
IQVIA RDS Inc., Calyx, Laboratory Corporation of America, Medidata Solutions, Thermo Fisher Scientific, Inc, CISCRP (Center for Information and Study on Clinical Research Participation), Quipment Inc., Little Journey Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05267613
Brief Title
Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis
Acronym
EE
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
August 14, 2026 (Anticipated)
Study Completion Date
November 6, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
Collaborators
IQVIA RDS Inc., Calyx, Laboratory Corporation of America, Medidata Solutions, Thermo Fisher Scientific, Inc, CISCRP (Center for Information and Study on Clinical Research Participation), Quipment Inc., Little Journey Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to determine if Nexium is safe and efficacious in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.
Detailed Description
Esomeprazole (NEXIUM™) is indicated for the maintenance of healing of endoscopy-verified erosive esophagitis (EE) in children 1 to 11 years of age in a number of countries worldwide, but not in the United States (US). The current study has been designed, in discussions with the Food and Drug Administration (FDA), to further evaluate the safety and efficacy of NEXIUM given as maintenance of healing of EE in children 1 to 11 years of age
Safety assessments will include the monitoring of adverse events throughout the study, clinical laboratory testing (including hematology, clinical chemistry, urinalysis), vital signs (including blood pressure and pulse), and physical examination including weight.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Esophagitis
Keywords
Erosive Esophagitis, Gastroesophageal Reflux Disease, Healing, Maintenance, Esophagogastroduodenoscopy, Endoscopy, EGD, GERD, GERD in children
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Masking only applies to the double-blind, randomized maintenance phase of 16 weeks.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nexium - high dose
Arm Type
Active Comparator
Arm Description
Arm 1 (High dose = Healing dose)
Arm Title
Nexium - Low dose
Arm Type
Active Comparator
Arm Description
Arm 2 (Low dose = ½ healing dose)
Intervention Type
Drug
Intervention Name(s)
Nexium 20mg
Intervention Description
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 Type
Drug
Intervention Name(s)
Nexium 10mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence / absence of Erosive Esophagitis
Description
Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase
Time Frame
Week 24 (end of 16-week maintenance phase)
Secondary Outcome Measure Information:
Title
Presence/absence of Erosive Esophagitis
Description
Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 8-week healing phase
Time Frame
Week 8 (end of healing phase)
Title
Percentage of days without rescue medication
Description
The percentage of days without rescue medication during the 8-week healing phase and during the 16-week maintenance phase
Time Frame
Week 8 (end of healing phase) and Week 16 (end of maintenance phase)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient must be 1 to 11 years of age
Patients must have a history of GERD for at least 3 months before the start of study
For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase.
For the maintenance phase: Patients must have completed the healing phase and have endoscopy-verified healed EE at the 8-week endoscopy visit.
Patients must weigh ≥ 10 kg.
Patients may be male or female.
All postmenarcheal female patients must have a negative pregnancy test (urine) before starting treatment.
Sexually active patients must be abstinent or maintain effective contraception from informed consent day up to the last day of IMP treatment.
Patient's guardian must be capable of giving signed informed consent
Exclusion Criteria:
Presence of other diseases, such as severe heart, lung, liver, renal, blood, or neurological disease or similar
Significant clinical illness within 4 weeks prior to the start of treatment
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)
Previous total gastrectomy
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
Participation in another clinical study with an IMP administered in the last 4 weeks before enrollment.
Patients with a known hypersensitivity to NEXIUM, or any other PPI, or any of the excipients of the product
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
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
Previous screening, or enrollment and randomization in the present study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cordoba
ZIP/Postal Code
5000
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
X5016KEH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Parana
ZIP/Postal Code
3100
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rosario
ZIP/Postal Code
S2000DEJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
North Adelaide
ZIP/Postal Code
5006
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Namur
ZIP/Postal Code
5101
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
54642
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
56249
Country
Greece
Individual Site Status
Recruiting
Facility Name
Research Site
City
Messina
ZIP/Postal Code
98125
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00137
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaunas
ZIP/Postal Code
LT50009
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vilnius
ZIP/Postal Code
LT-08406
Country
Lithuania
Individual Site Status
Recruiting
Facility Name
Research Site
City
Braga
ZIP/Postal Code
4710
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Coimbra
ZIP/Postal Code
3000-602
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1169-045
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1500-650
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Viana do Castelo
ZIP/Postal Code
4901-858
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Research Site
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint Petersburg
ZIP/Postal Code
196240
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Saint-Petersburg
ZIP/Postal Code
196158
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Research Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ha Noi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hochiminh
Country
Vietnam
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis
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