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

NCT04821310 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: B17910942023-508770-28-00
• Study Type: interventional
• Target: 43
• Locations: 9 countries
• Sites: 28

Brief 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.

Conditions

Esophagitis

Keywords

Erosive; esophagitis

Outcome Measures

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.

  Week 24

Secondary Outcomes (3)

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

  Baseline up to 36 weeks

• Incidence of Adverse Events (AEs)

  Baseline up to 36 weeks

• Number of Participants With Change From Baseline in Laboratory Tests Results

  Baseline up to 36 weeks

Study Arms (2)

Arm 1 Full Dose Pantoprazole and matching placebo

ACTIVE COMPARATOR

Full Healing Dose of pantoprazole

Drug: Full dose Pantoprazole plus matching placebo

Arm 2 Half Dose Pantoprazole and matching placebo

ACTIVE COMPARATOR

Half Healing Dose of pantoprazole

Drug: Half Dose Pantoprazole plus matching placebo

Interventions

Half Dose Pantoprazole plus matching placebo DRUG

Half healing dose of pantoprazole plus matching placebo

Arm 2 Half Dose Pantoprazole and matching placebo

Full dose Pantoprazole plus matching placebo DRUG

Full healing dose of pantoprazole plus matching placebo

Arm 1 Full Dose Pantoprazole and matching placebo

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Pfizer: lead

Study Sites (28)

Baptist/Wolfson's Children's Hospital

Jacksonville, Florida, 32207, United States

Location

Nemours Children's Health, Jacksonville

Jacksonville, Florida, 32207, United States

Location

University of Rochester

Rochester, New York, 14627, United States

Location

University of Rochester Medical Center Clinical Research Center

Rochester, New York, 14642, United States

Location

Board of Regents of the University of Wisconsin System

Madison, Wisconsin, 53715, United States

Location

UW Health E Terrace Dr Medical Center

Madison, Wisconsin, 53718, United States

Location

University Hospital and UW Health Clinics

Madison, Wisconsin, 53792, United States

Location

UW Health 2275 Deming Way Clinic

Middleton, Wisconsin, 53562, United States

Location

University clinical center of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

Evex clinic after I. Tsitsishvili

Tbilisi, 0159, Georgia

Location

JSC Georgian Clinics

Tbilisi, 0159, Georgia

Location

LTD Imedi Clinic

Tbilisi, 0159, Georgia

Location

Georgian-American Family Medicine Clinic

Tbilisi, 0171, Georgia

Location

SR Kalla Memorial Gastro & General Hospital

Jaipur, Rajasthan, 302001, India

Location

Medical college and Hospital

Kolkata, West Bengal, 700073, India

Location

Hospital HIMA San Pablo Caguas

Caguas, 00725, Puerto Rico

Location

Chiara Biaggi de Casenave, MD

Guaynabo, 00969, Puerto Rico

Location

University Children's Hospital

Belgrade, 11000, Serbia

Location

University Clinical Center of Kragujevac

Kragujevac, 34000, Serbia

Location

Univerzitna nemocnica Martin, Klinika deti a dorastu

Martin, 036 59, Slovakia

Location

KM Management, spol. s r.o.,

Nitra, 94901, Slovakia

Location

MDX Klinik Arastirma Egitim ve Danismanlik Ltd

Istanbul, 34880, Turkey (Türkiye)

Location

Izmir Saglik Bilimleri University Tepecik Training And Research Hospital

Izmir, 35340, Turkey (Türkiye)

Location

T.C. Saglik Bakanligi - Izmir Sehir Hastanesi

Izmir, 35540, Turkey (Türkiye)

Location

Evelina London Children's Hospital

London, SE1 7EH, United Kingdom

Location

Guys & St Thomas Nhs Foundation

London, SE1 9RT, United Kingdom

Location

King's College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

Location

Great Ormond Street Hospital For Children NHS Foundation Trust

London, WC1N 3JH, United Kingdom

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Esophagitis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized, double-blind

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: March 29, 2021
• Study Start: January 13, 2022
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (4); PR (2); IN (2); BO (1); SE (2); GE (4); US (8); SL (2); TU (3)