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Pantoprazole Dose Comparison for Esophagitis

Phase 2

Recruiting

Research Sponsored by Pfizer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female participants aged 1 to 17 years

Participants must have a documented erosive lesion with an Los Angeles (LA) Grade of A to D prior to starting Proton Pump Inhibitor treatment

Must not have

Known history of human immunodeficiency virus or clinical manifestations of acquired immune deficiency syndrome

Family history of malignant hyperthermia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 36 weeks

Summary

This trial will compare two doses of oral pantoprazole for the maintenance of healing of erosive esophagitis in pediatric participants.

Who is the study for?

Children aged 1-17 with healed erosive esophagitis are eligible for this trial. They must weigh at least 7 kg and be in the CDC's weight percentile for their age. Participants need to consent, use an eDiary, and follow study procedures. Exclusions include hypersensitivity to Proton Pump Inhibitors, certain gastrointestinal disorders, psychiatric conditions, chronic medication use that interferes with the study drug, or significant lab abnormalities.

What is being tested?

The trial is testing two doses of oral pantoprazole (full healing dose and half healing dose) based on weight to maintain healing of erosive esophagitis in children. The effectiveness and safety of these doses will be compared over time.

What are the potential side effects?

Pantoprazole may cause side effects such as headaches, diarrhea, stomach pain, nausea or vomiting; however serious allergic reactions are rare. Long-term use can lead to vitamin B12 deficiency or bone fractures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 1 and 17 years old.

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I have a documented erosive lesion graded A to D before starting acid reflux treatment.

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I can fill out the eDiary myself or have a guardian who can.

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My weight is at least at the 5th percentile for my age according to CDC standards.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV/AIDS.

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My family has a history of malignant hyperthermia.

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I use medication daily for a chronic condition.

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I have had problems with my upper digestive system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 36 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Number of Participants With Change From Baseline in Laboratory Tests Results

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