Erosive EsophagitisPhase 3EENCT05267613
Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.
A Phase 3 study testing Nexium 20mg and Nexium 10mg in people with Erosive Esophagitis, run by AstraZeneca at 41 sites in 10 countries.
Trial summary
The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age. Read more about this study
- Who is it for?
- Ages 1 year to 11 years
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- Nexium 20mg and Nexium 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 41 sitesin 10 countries
- Study dates
- 1 Jul 2022to 10 Aug 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient must be 1 to 11 years of age
- Patients must have a clinical 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.
Show all 9Show fewer
- 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 study intervention.
- Patient's guardian must be capable of giving signed informed consent
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
41 sites in 10 countries.
41 sites in 10 countries
United States11 sites
Research Site
Akron, Ohio, 44308
Research Site
Carmel, Indiana, 46290
Research Site
Cleveland, Ohio, 44195
Research Site
Miami, Florida, 33122
Research Site
Miami, Florida, 33155
Research Site
Milwaukee, Wisconsin, 53226
Research Site
Mobile, Alabama, 36604
Research Site
Orlando, Florida, 32806
Research Site
Sacramento, California, 95817
Research Site
Shreveport, Louisiana, 71103
Research Site
The Bronx, New York, 10468
Portugal7 sites
Research Site
Coimbra, 3000-602
Research Site
Lisbon, 1169-045
Research Site
Lisbon, 1500-650
Research Site
Lisbon, 1998-018
Research Site
Porto, 4099-001
Research Site
Porto, 4200-319
Research Site
Viana do Castelo, 4901-858
Italy5 sites
Research Site
Messina, 98124
Research Site
Naples, 80131
Research Site
Naples, 80138
Research Site
Roma, 00137
Research Site
Roma, 00161
Argentina4 sites
Research Site
Córdoba, 5000
Research Site
Córdoba, X5016KEH
Research Site
Paraná, 3100
Research Site
Rosario, S2000DEJ
Spain4 sites
Research Site
Badalona, 08916
Research Site
Santiago de Compostela, 15706
Research Site
Seville, 41009
Research Site
Seville, 41013
Vietnam4 sites
Research Site
Hà Nội, 100000
Research Site
Hanoi, 100000
Research Site
Hanoi, 10000
Research Site
Hochiminh, 700000
Greece3 sites
Research Site
Athens, 11527
Research Site
Thessaloniki, 54642
Research Site
Thessaloniki, 56249
About this study
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
The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.
Read the 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.
- Conditions
- Erosive Esophagitis
- Being tested
- Nexium 20mg, Nexium 10mg
- Keywords
- Erosive Esophagitis, Gastroesophageal Reflux Disease, Healing, Maintenance, Esophagogastroduodenoscopy, Endoscopy, EGD, GERD, GERD in children
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexium 20mgDrug
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.
Nexium 10mgDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Nexium - high dose | Active comparator | Arm 1 (High dose = Healing dose) Receives: Drug: Nexium 20mg |
| Nexium - Low dose | Active comparator | Arm 2 (Low dose = ½ healing dose) Receives: Drug: Nexium 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 24 (end of 16-week maintenance phase)
Secondary outcomes (2)
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
Measured: Week 8 (end of 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
Measured: Week 8 (end of healing phase) and Week 16 (end of maintenance phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start1 Jul 2022
- Primary completion10 Aug 2026
- Study completion10 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive EsophagitisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- IQVIA RDS Inc., Calyx, Laboratory Corporation of America, Medidata Solutions, Thermo Fisher Scientific, Inc, CISCRP, Quipment Inc., Little Journey Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05267613
- Sponsor's protocol ID
- D9612C09998
- Other IDs
- 2023-505454-18-00, 2020-002515-21, 2023
- Acronym
- EE
- Status last verified
- Oct 2026
- First submitted
- 31 Jan 2022
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
- Expanded access
- Available