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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
Capable of giving signed informed consent/assent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 36 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 am able to understand and sign the consent form.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Incidence of Adverse Events (AEs)
Number of Participants With Change From Baseline in Laboratory Tests Results
Number of Participants With Change From Baseline in Physical Examinations and Vital Signs

Trial Design

2Treatment groups
Active Control
Group I: Arm 1 Full Dose Pantoprazole and matching placeboActive Control1 Intervention
Full Healing Dose of pantoprazole
Group II: Arm 2 Half Dose Pantoprazole and matching placeboActive Control1 Intervention
Half Healing Dose of pantoprazole

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,562 Previous Clinical Trials
10,907,016 Total Patients Enrolled
2 Trials studying Esophagitis
61,972 Patients Enrolled for Esophagitis
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,471 Previous Clinical Trials
8,088,407 Total Patients Enrolled
2 Trials studying Esophagitis
61,972 Patients Enrolled for Esophagitis

Media Library

Full dose Pantoprazole plus matching placebo Clinical Trial Eligibility Overview. Trial Name: NCT04821310 — Phase 2
Esophagitis Research Study Groups: Arm 1 Full Dose Pantoprazole and matching placebo, Arm 2 Half Dose Pantoprazole and matching placebo
Esophagitis Clinical Trial 2023: Full dose Pantoprazole plus matching placebo Highlights & Side Effects. Trial Name: NCT04821310 — Phase 2
Full dose Pantoprazole plus matching placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04821310 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment for this trial currently open?

"Affirmative. The clinical trial database shows that this research is currently enrolling participants, beginning from January 13th 2022. As of November 8th 2022, the study has been updated and now requires 110 patients at 10 sites for participation."

Answered by AI

How many sites are actively overseeing this clinical research?

"This research trial has 10 distinct clinical sites that are recruiting patients, such as UPMC Children's Hospital of Pittsburgh in Pittsburgh, Unity Point Health Pediatric Gastroenterology in Peoria, and The University of Chicago Medical Center. Additionally, there are 7 more locations involved with the study."

Answered by AI

What qualifications are necessary to be eligible for this research?

"This medical trial is searching for 110 individuals aged between 1 and 17 years old with esophagitis. To be eligible, participants must fulfil the following requirements: Consent to participation in all study procedures including using an eDiary; sign informed consent/assent forms; minimum body weight of 7 kg and meet 5th percentile standards set by the Center for Disease Control (CDC); premenarchal status discussion during office visits or phone calls when applicable; willingness and ability to complete the eDiary."

Answered by AI

How many participants has the research team enlisted for this experiment?

"To properly conduct this trial, Pfizer is searching for 110 qualifying patients. To do so, the company has designated UPMC Children's Hospital of Pittsburgh (Pennsylvania) and Unity Point Health Pediatric Gastroenterology (Illinois) as official study sites."

Answered by AI

Has this remedy received federal authorization from the FDA?

"Our team from Power gave the treatment a score of 2 since it is in Phase 2 clinical testing, with some evidence for its safety but none yet to prove efficacy."

Answered by AI

Are individuals aged 25 and older eligible for enrollment in this research?

"According to the requirements for participation in this trial, infants one year of age and older can be included as well as those under 18."

Answered by AI
~69 spots leftby Dec 2027