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Study Summary
This trial will compare two doses of oral pantoprazole for the maintenance of healing of erosive esophagitis in pediatric participants.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You are allergic to any Proton Pump Inhibitor medication, including pantoprazole, or any similar medications.You have a history of or currently have problems with your stomach or intestines that affect how they work.You have a medical or mental health condition that could increase the risks of participating in the study or interfere with the study results. This includes recent or active thoughts of suicide or behavior.Your family has a history of a condition called malignant hyperthermia.
- Group 1: Arm 1 Full Dose Pantoprazole and matching placebo
- Group 2: Arm 2 Half Dose Pantoprazole and matching placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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