ClinicalTrials.gg
TerminatedNCT04821310Updated Jun 15, 2026

Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years

A Phase 2 interventional study of Full dose Pantoprazole plus matching placebo and Half Dose Pantoprazole plus matching placebo in Esophagitis, sponsored by Pfizer. Terminated at 27 sites in 9 countries. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Pfizer · Phase 2, Interventional, and Treatment

Why this study was terminated
Pfizer has made an internal business decision to terminate the B1791094 study. This decision was not due to safety concerns or requests from any regulatory authorities.
Phase
Phase 2
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
1 Year to 17 Years
Sex
All
01

Study summary

The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.

Read the detailed description

Explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis.

02

Conditions studied

  • Esophagitis

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Keywords

  • Erosive
  • esophagitis
03

In context

Esophagitis

123 studies on the registry are indexed under Esophagitis; 15 are open to participants now.

This study's enrollment of 43 is below the median of 96 across 99 interventional studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 /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 , 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

Exclusion Criteria:

  • Previous administration of an 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 to any Proton Pump Inhibitor, including pantoprazole or to any substituted benzimidazole or to any of the .
  • 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 .
  • Known history of or clinical manifestations of acquired immune deficiency syndrome.
  • Active 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.
  • 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 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 (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
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
43 participants (actual)

Study arms

  • Active comparator
    Arm 1 Full Dose Pantoprazole and matching placebo

    Full Healing Dose of pantoprazole

    Drug: Full dose Pantoprazole plus matching placebo

  • Active comparator
    Arm 2 Half Dose Pantoprazole and matching placebo

    Half Healing Dose of pantoprazole

    Drug: Half Dose Pantoprazole plus matching placebo

Interventions

  • DrugFull dose Pantoprazole plus matching placebo

    Full healing dose of pantoprazole plus matching placebo

  • DrugHalf Dose Pantoprazole plus matching placebo

    Half healing dose of pantoprazole plus matching placebo

06

What researchers measure

Primary outcomes

  1. Proportion of patients with endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24, considering patients with excessive use of rescue medication as treatment failures

    Endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24.

    Time frame: Week 24

Secondary outcomes

  1. Number of Participants With Change From Baseline in Physical Examinations and Vital Signs

    Safety and tolerability will be assessed by physical examinations, blood pressure, and pulse rate.

    Time frame: Baseline up to 36 weeks

  2. Incidence of Adverse Events (AEs)

    Time frame: Baseline up to 36 weeks

  3. Number of Participants With Change From Baseline in Laboratory Tests Results

    Safety and tolerability will be assessed by clinical laboratory measurements

    Time frame: Baseline up to 36 weeks

07

Study locations

27 sites
  • Baptist/Wolfson's Children's Hospital
    Jacksonville, Florida 32207, United States
  • Nemours Children's Health, Jacksonville
    Jacksonville, Florida 32207, United States
  • University of Rochester
    Rochester, New York 14627, United States
  • University of Rochester Medical Center Clinical Research Center
    Rochester, New York 14642, United States
  • Board of Regents of the University of Wisconsin System
    Madison, Wisconsin 53715, United States
  • UW Health E Terrace Dr Medical Center
    Madison, Wisconsin 53718, United States
  • University Hospital and UW Health Clinics
    Madison, Wisconsin 53792, United States
  • UW Health 2275 Deming Way Clinic
    Middleton, Wisconsin 53562, United States
  • University clinical center of the Republic of Srpska
    Banja Luka, 78000, Bosnia and Herzegovina
  • JSC Georgian Clinics
    Tbilisi, 0159, Georgia
  • LTD Imedi Clinic
    Tbilisi, 0159, Georgia
  • Georgian-American Family Medicine Clinic
    Tbilisi, 0171, Georgia
  • SR Kalla Memorial Gastro & General Hospital
    Jaipur, Rajasthan 302001, India
  • Medical college and Hospital
    Kolkata, West Bengal 700073, India
  • Hospital HIMA San Pablo Caguas
    Caguas, 00725, Puerto Rico
  • Chiara Biaggi de Casenave, MD
    Guaynabo, 00969, Puerto Rico
  • University Children's Hospital
    Belgrade, 11000, Serbia
  • University Clinical Center of Kragujevac
    Kragujevac, 34000, Serbia
  • Univerzitna nemocnica Martin, Klinika deti a dorastu
    Martin, 036 59, Slovakia
  • KM Management, spol. s r.o.,
    Nitra, 94901, Slovakia
  • MDX Klinik Arastirma Egitim ve Danismanlik Ltd
    Istanbul, 34880, Turkey (Türkiye)
  • Izmir Saglik Bilimleri University Tepecik Training And Research Hospital
    Izmir, 35340, Turkey (Türkiye)
  • T.C. Saglik Bakanligi - Izmir Sehir Hastanesi
    Izmir, 35540, Turkey (Türkiye)
  • Evelina London Children's Hospital
    London, SE1 7EH, United Kingdom
  • Guys & St Thomas Nhs Foundation
    London, SE1 9RT, United Kingdom
  • King's College Hospital NHS Foundation Trust
    London, SE5 9RS, United Kingdom
  • Great Ormond Street Hospital For Children NHS Foundation Trust
    London, WC1N 3JH, United Kingdom
08

References and documents

Individual participant data

Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Data sharing details ↗ · www.pfizer.com

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04821310
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Mar 29, 2021
Start date
Jan 13, 2022
Primary completion
Dec 16, 2025
Completion
Dec 16, 2025
Last update
Jun 15, 2026

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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