EsophagitisPhase 2NCT04821310
Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years
A Phase 2 study of Esophagitis, run by Pfizer at 27 sites in 9 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Esophagitis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 27 sitesin 9 countries
- Study dates
- 13 Jan 2022to 16 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 18Show fewer
- 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
Trial locations and contacts
27 sites in 9 countries.
27 sites in 9 countries
United States8 sites
Baptist/Wolfson's Children's Hospital
Jacksonville, Florida, 32207
Nemours Children's Health, Jacksonville
Jacksonville, Florida, 32207
Board of Regents of the University of Wisconsin System
Madison, Wisconsin, 53715
UW Health E Terrace Dr Medical Center
Madison, Wisconsin, 53718
University Hospital and UW Health Clinics
Madison, Wisconsin, 53792
UW Health 2275 Deming Way Clinic
Middleton, Wisconsin, 53562
University of Rochester
Rochester, New York, 14627
University of Rochester Medical Center Clinical Research Center
Rochester, New York, 14642
United Kingdom4 sites
Evelina London Children's Hospital
London, SE1 7EH
Guys & St Thomas Nhs Foundation
London, SE1 9RT
King's College Hospital NHS Foundation Trust
London, SE5 9RS
Great Ormond Street Hospital For Children NHS Foundation Trust
London, WC1N 3JH
Georgia3 sites
JSC Georgian Clinics
Tbilisi, 0159
LTD Imedi Clinic
Tbilisi, 0159
Georgian-American Family Medicine Clinic
Tbilisi, 0171
Turkey (Türkiye)3 sites
MDX Klinik Arastirma Egitim ve Danismanlik Ltd
Istanbul, 34880
Izmir Saglik Bilimleri University Tepecik Training And Research Hospital
Izmir, 35340
T.C. Saglik Bakanligi - Izmir Sehir Hastanesi
Izmir, 35540
India2 sites
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001
Medical college and Hospital
Kolkata, West Bengal, 700073
Puerto Rico2 sites
Hospital HIMA San Pablo Caguas
Caguas, 00725
Chiara Biaggi de Casenave, MD
Guaynabo, 00969
Serbia2 sites
University Children's Hospital
Belgrade, 11000
University Clinical Center of Kragujevac
Kragujevac, 34000
Slovakia2 sites
Univerzitna nemocnica Martin, Klinika deti a dorastu
Martin, 036 59
KM Management, spol. s r.o.,
Nitra, 94901
Bosnia and Herzegovina1 site
University clinical center of the Republic of Srpska
Banja Luka, 78000
About this study
Official title: 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
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.
- Conditions
- Esophagitis
- Being tested
- Full dose Pantoprazole plus matching placebo, Half Dose Pantoprazole plus matching placebo
- Keywords
- Erosive, esophagitis
- Medical subject headings
- Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full dose Pantoprazole plus matching placeboDrug
Full healing dose of pantoprazole plus matching placebo
Half Dose Pantoprazole plus matching placeboDrug
Half healing dose of pantoprazole plus matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 Full Dose Pantoprazole and matching placebo | Active comparator | Full Healing Dose of pantoprazole Receives: Drug: Full dose Pantoprazole plus matching placebo |
| Arm 2 Half Dose Pantoprazole and matching placebo | Active comparator | Half Healing Dose of pantoprazole Receives: Drug: Half Dose Pantoprazole plus matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (3)
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.
Measured: Baseline up to 36 weeks
Incidence of Adverse Events (AEs)
Measured: Baseline up to 36 weeks
Number of Participants With Change From Baseline in Laboratory Tests Results
Safety and tolerability will be assessed by clinical laboratory measurements
Measured: Baseline up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start13 Jan 2022
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagitisStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821310
- Sponsor's protocol ID
- B1791094
- Other IDs
- 2020-005030-15, 2023-508770-28-00, 2023
- Status last verified
- Jun 2026
- First submitted
- 26 Mar 2021
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04821310
- Acronym / sponsor ID
- B1791094
- Conditions
- Esophagitis
- Keywords
- Erosive, esophagitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 43 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2022 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double-blind
| Arm | Type | Receives |
|---|---|---|
| Arm 1 Full Dose Pantoprazole and matching placebo | Active comparator | Drug: Full dose Pantoprazole plus matching placeboFull Healing Dose of pantoprazole |
| Arm 2 Half Dose Pantoprazole and matching placebo | Active comparator | Drug: Half Dose Pantoprazole plus matching placeboHalf Healing Dose of pantoprazole |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full dose Pantoprazole plus matching placeboFull healing dose of pantoprazole plus matching placebo | Drug | Arm 1 Full Dose Pantoprazole and matching placebo |
| Half Dose Pantoprazole plus matching placeboHalf healing dose of pantoprazole plus matching placebo | Drug | Arm 2 Half Dose Pantoprazole and matching placebo |
Primary outcome
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
Time frame: Week 24
Endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24.
3 secondary outcomes
Number of Participants With Change From Baseline in Physical Examinations and Vital Signs
Time frame: Baseline up to 36 weeks
Incidence of Adverse Events (AEs)
Time frame: Baseline up to 36 weeks
Number of Participants With Change From Baseline in Laboratory Tests Results
Time frame: Baseline up to 36 weeks
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Esophagitis
Recruiting
The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States
Dysphagia, Eosinophilic Esophagitis
Not yet recruitingPhase 3
Risk-Adapted Segmental Esophagus-Sparing Radiotherapy for Definitive Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
Recruiting
SPADE Clinical Trial.
Early Gastric Cancer, Adenocarcinoma of the Stomach
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
27 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Esophagitis, run by Pfizer at 27 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, United Kingdom, Georgia, Turkey (Türkiye), India and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.