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Treatment for maintaining healing of esophagitis in children

AN EXPLORATORY, MULTICENTER, RANDOMIZED, DOUBLE BLIND STUDY OF CLINICAL OUTCOMES, TOLERABILITY, AND SAFETY OF 2 DOSES OF ORAL PANTOPRAZOLE IN PEDIATRIC PARTICIPANTS AGED 1 TO 11 YEARS AND 12 TO 17 YEARS WHO REQUIRE MAINTENANCE THERAPY FOR HEALED EROSIVE ESOPHAGITIS

Phase 2 Interventional Pfizer · NCT04821310

This study is testing two different doses of a medication called pantoprazole to see which one helps children aged 1 to 17 keep their esophagitis healed.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment110 (estimated)
Ages1 Year to 17 Years
SexAll
SponsorPfizer Industry-sponsored
Drugs / interventionschemotherapy, methotrexate, prednisone
Locations53 sites (Orange, California and 52 other locations)
Trial IDNCT04821310 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness, tolerability, and safety of two different doses of oral pantoprazole, a proton pump inhibitor, for maintaining the healing of erosive esophagitis in pediatric participants aged 1 to 17 years. Participants will be assigned to receive either a full healing dose or a half healing dose based on their weight. The study aims to include children with endoscopically-confirmed, healed erosive esophagitis and will require participants to complete an electronic diary to track their progress. The outcomes will help determine the best dosing strategy for this age group.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 1 to 17 years with a documented history of erosive esophagitis who have achieved healing.

Not a fit: Patients with non-erosive esophagitis or those who do not meet the weight and age criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective maintenance treatment for children with erosive esophagitis, improving their quality of life.

How similar studies have performed: Previous studies on proton pump inhibitors have shown positive outcomes in treating erosive esophagitis, suggesting this approach may be effective.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Orange, California and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions EsophagitisErosiveesophagitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.