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Children's heartburn drug study halted early

NCT ID NCT04821310

Disease control Sponsor: Pfizer 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a full or half dose of pantoprazole could keep the esophagus healed in children aged 1 to 17 who had erosive esophagitis. The goal was to see which dose worked better and was safer. The study was stopped early, so results are limited.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

43 people

The number who actually took part.

Started

Jan 2022

Finished

Dec 2025

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 17 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: * Participants must have a documented erosive lesion with an Los Angeles (LA) Grade of A to D prior to starting Proton Pump Inhibitor treatment: * Capable of giving signed informed consent/assent * Willingness and ability of the participant or parent/legal guardian to complete the eDiary * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including the use of the eDiary. * Male and female participants aged 1 to 17 years. * Minimum body weight 7 kilogram and weight at least at the 5th percentile per the Center for Disease Control standard age and weight chart, for the participant's age. * To be considered a female of non childbearing potential, the participant must meet at least 1 of the following criteria : * Premenarchal: The investigator (or other appropriate staff) must discuss the participant's premenarchal status with the participant and parent/legal guardian at office visits and during telephone contacts, as participants who achieve menarche during the study would no longer be considered "female participants of non childbearing potential" and must comply with the protocol requirements applicable to women of childbearing potential. Exclusion Criteria: * Previous administration of an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). * Children that may be at high risk from procedural sedation should be carefully evaluated. Participants with a history of complications during prior procedural sedation * History or presence of upper gastrointestinal anatomic or motor disorders * Family history of malignant hyperthermia * Known hypersensitivity to any Proton Pump Inhibitor, including pantoprazole or to any substituted benzimidazole or to any of the excipients. * Any disorder requiring chronic (daily) use of warfarin, heparin, other anticoagulants, methotrexate, atazanavir or nelfinavir, clopidogrel, or potent inhibitors or inducers of CYP2C19 (eg, phenytoin, sulfamethoxazole, valproic acid, carbamazepine, and griseofulvin). * Serum creatine kinase levels \>3 x upper limit of normal. * Known history of human immunodeficiency virus or clinical manifestations of acquired immune deficiency syndrome. * Active malignancy of any type, or history of a malignancy. Participants with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable. * Diagnosed as having or has received treatment for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days before the Screening visit. * Alanine aminotransferase or blood urea nitrogen \>2.0 upper limit of normal or estimated creatinine \>1.5 X upper limit of normal for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before the Baseline Visit (Day 1). * Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. * Has, in the Investigator's opinion, a serious chronic condition (eg, diabetes, epilepsy), which is either not stable or not well controlled and may interfere with the conduct of the study. * Has any condition possibly affecting drug absorption (eg, gastrectomy). Prior or Concomitant Therapy: * Frequent, repeated use of oral or parenteral glucocorticoids (eg, prednisone, prednisolone, dexamethasone). Steroid inhalers and topical steroids may be used. * Pregnant female participants; breastfeeding female participants. * Is unwilling or unable to comply with the Lifestyle Considerations section

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Conditions

The condition(s) this trial relates to.

esophagitis peptic esophagitis

As listed by the trial registrant

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

Esophagitis

Contacts and locations

Locations

  • Baptist/Wolfson's Children's Hospital

    Jacksonville, Florida, 32207, United States

  • Board of Regents of the University of Wisconsin System

    Madison, Wisconsin, 53715, United States

  • Chiara Biaggi de Casenave, MD

    Guaynabo, 00969, Puerto Rico

  • Evelina London Children's Hospital

    London, SE1 7EH, United Kingdom

  • Georgian-American Family Medicine Clinic

    Tbilisi, 0171, Georgia

  • Great Ormond Street Hospital For Children NHS Foundation Trust

    London, WC1N 3JH, United Kingdom

  • Guys & St Thomas Nhs Foundation

    London, SE1 9RT, United Kingdom

  • Hospital HIMA San Pablo Caguas

    Caguas, 00725, Puerto Rico

  • Izmir Saglik Bilimleri University Tepecik Training And Research Hospital

    Izmir, 35340, Turkey (Türkiye)

  • JSC Georgian Clinics

    Tbilisi, 0159, Georgia

  • KM Management, spol. s r.o.,

    Nitra, 94901, Slovakia

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS, United Kingdom

  • LTD Imedi Clinic

    Tbilisi, 0159, Georgia

  • MDX Klinik Arastirma Egitim ve Danismanlik Ltd

    Istanbul, 34880, Turkey (Türkiye)

  • Medical college and Hospital

    Kolkata, West Bengal, 700073, India

  • Nemours Children's Health, Jacksonville

    Jacksonville, Florida, 32207, United States

  • SR Kalla Memorial Gastro & General Hospital

    Jaipur, Rajasthan, 302001, India

  • T.C. Saglik Bakanligi - Izmir Sehir Hastanesi

    Izmir, 35540, Turkey (Türkiye)

  • UW Health 2275 Deming Way Clinic

    Middleton, Wisconsin, 53562, United States

  • UW Health E Terrace Dr Medical Center

    Madison, Wisconsin, 53718, United States

  • University Children's Hospital

    Belgrade, 11000, Serbia

  • University Clinical Center of Kragujevac

    Kragujevac, 34000, Serbia

  • University Hospital and UW Health Clinics

    Madison, Wisconsin, 53792, United States

  • University clinical center of the Republic of Srpska

    Banja Luka, 78000, Bosnia and Herzegovina

  • University of Rochester

    Rochester, New York, 14627, United States

  • University of Rochester Medical Center Clinical Research Center

    Rochester, New York, 14642, United States

  • Univerzitna nemocnica Martin, Klinika deti a dorastu

    Martin, 036 59, Slovakia

More trials for these conditions

Other studies related to the condition(s) this trial covers.