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Can nexium keep Kids' esophagitis at bay? new study seeks answers

NCT ID NCT05267613

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 28, 2026 · Updated 3 times

Summary

This phase 3 study tests two doses of Nexium (esomeprazole) in 53 children aged 1 to 11 years who have erosive esophagitis, a condition where stomach acid damages the esophagus. The goal is to see which dose better maintains healing after an initial 8-week treatment period. Children take the medicine daily for 16 weeks, and doctors check healing with a scope at the end.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nexium (esomeprazole)
What this could lead to
If successful, this could confirm a safe and effective dose of Nexium to prevent erosive esophagitis from coming back in young children.
What could go wrong
This is a small, early-phase study with only 53 children, so results may not apply to all kids. Long-term safety and effectiveness are not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

53 people

The number who actually took part.

Started

Jul 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 11 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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

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Conditions

The condition(s) this trial relates to.

esophagitis gastroesophageal reflux disease peptic esophagitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Erosive esophagitis

Contacts and locations

Locations

  • Research Site

    Mobile, Alabama, 36604, United States

  • Research Site

    Sacramento, California, 95817, United States

  • Research Site

    Miami, Florida, 33122, United States

  • Research Site

    Miami, Florida, 33155, United States

  • Research Site

    Orlando, Florida, 32806, United States

  • Research Site

    Carmel, Indiana, 46290, United States

  • Research Site

    Shreveport, Louisiana, 71103, United States

  • Research Site

    The Bronx, New York, 10468, United States

  • Research Site

    Akron, Ohio, 44308, United States

  • Research Site

    Cleveland, Ohio, 44195, United States

  • Research Site

    Milwaukee, Wisconsin, 53226, United States

  • Research Site

    Córdoba, 5000, Argentina

  • Research Site

    Córdoba, X5016KEH, Argentina

  • Research Site

    Paraná, 3100, Argentina

  • Research Site

    Rosario, S2000DEJ, Argentina

  • Research Site

    Clayton, 3168, Australia

  • Research Site

    Namur, 5101, Belgium

  • Research Site

    Athens, 11527, Greece

  • Research Site

    Thessaloniki, 54642, Greece

  • Research Site

    Thessaloniki, 56249, Greece

  • Research Site

    Messina, 98124, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Naples, 80138, Italy

  • Research Site

    Roma, 00137, Italy

  • Research Site

    Roma, 00161, Italy

  • Research Site

    Vilnius, LT-08406, Lithuania

  • Research Site

    Coimbra, 3000-602, Portugal

  • Research Site

    Lisbon, 1169-045, Portugal

  • Research Site

    Lisbon, 1500-650, Portugal

  • Research Site

    Lisbon, 1998-018, Portugal

  • Research Site

    Porto, 4099-001, Portugal

  • Research Site

    Porto, 4200-319, Portugal

  • Research Site

    Viana do Castelo, 4901-858, Portugal

  • Research Site

    Badalona, 08916, Spain

  • Research Site

    Santiago de Compostela, 15706, Spain

  • Research Site

    Seville, 41009, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Hanoi, 10000, Vietnam

  • Research Site

    Hà Nội, 100000, Vietnam

  • Research Site

    Hochiminh, 700000, Vietnam

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