Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years
NCT ID: NCT04821310
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2022-01-13
2025-12-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1 Full Dose Pantoprazole and matching placebo
Full Healing Dose of pantoprazole
Full dose Pantoprazole plus matching placebo
Full healing dose of pantoprazole plus matching placebo
Arm 2 Half Dose Pantoprazole and matching placebo
Half Healing Dose of pantoprazole
Half Dose Pantoprazole plus matching placebo
Half healing dose of pantoprazole plus matching placebo
Interventions
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Full dose Pantoprazole plus matching placebo
Full healing dose of pantoprazole plus matching placebo
Half Dose Pantoprazole plus matching placebo
Half healing dose of pantoprazole plus matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Baptist/Wolfson's Children's Hospital
Jacksonville, Florida, United States
Nemours Children's Health, Jacksonville
Jacksonville, Florida, United States
University of Rochester
Rochester, New York, United States
University of Rochester Medical Center Clinical Research Center
Rochester, New York, United States
Board of Regents of the University of Wisconsin System
Madison, Wisconsin, United States
UW Health E Terrace Dr Medical Center
Madison, Wisconsin, United States
University Hospital and UW Health Clinics
Madison, Wisconsin, United States
UW Health 2275 Deming Way Clinic
Middleton, Wisconsin, United States
University clinical center of the Republic of Srpska
Banja Luka, , Bosnia and Herzegovina
JSC Georgian Clinics
Tbilisi, , Georgia
LTD Imedi Clinic
Tbilisi, , Georgia
Georgian-American Family Medicine Clinic
Tbilisi, , Georgia
Evex clinic after I. Tsitsishvili
Tbilisi, , Georgia
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, India
Medical college and Hospital
Kolkata, West Bengal, India
Hospital HIMA San Pablo Caguas
Caguas, , Puerto Rico
Chiara Biaggi de Casenave, MD
Guaynabo, , Puerto Rico
University Children's Hospital
Belgrade, , Serbia
University Clinical Center of Kragujevac
Kragujevac, , Serbia
Univerzitna nemocnica Martin, Klinika deti a dorastu
Martin, , Slovakia
KM Management, spol. s r.o.,
Nitra, , Slovakia
MDX Klinik Arastirma Egitim ve Danismanlik Ltd
Istanbul, , Turkey (Türkiye)
Izmir Saglik Bilimleri University Tepecik Training And Research Hospital
Izmir, , Turkey (Türkiye)
T.C. Saglik Bakanligi - Izmir Sehir Hastanesi
Izmir, , Turkey (Türkiye)
Evelina London Children's Hospital
London, , United Kingdom
Guys & St Thomas Nhs Foundation
London, , United Kingdom
King's College Hospital NHS Foundation Trust
London, , United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London, , United Kingdom
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2023-508770-28-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
B1791094
Identifier Type: -
Identifier Source: org_study_id