Study on the Effects and Safety of Pantoprazole for Children and Teens with Healed Erosive Esophagitis

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What is this study about?

This clinical trial is focused on studying the effects of a medication called pantoprazole in children and teenagers who have a condition known as erosive esophagitis. Erosive esophagitis is a condition where the lining of the esophagus, the tube that carries food from the mouth to the stomach, becomes inflamed and damaged. The purpose of the study is to explore how well pantoprazole can maintain the healing of this condition in participants aged 1 to 17 years.

Participants in the study will receive pantoprazole in the form of a capsule, which they will take by mouth. The study will compare two different doses of pantoprazole to see which is more effective and safe for maintaining the healing of erosive esophagitis. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient. The study will last for up to 24 weeks, during which time participants will have regular check-ups to monitor their health and the condition of their esophagus.

The study will assess the safety and tolerability of pantoprazole by conducting physical examinations and monitoring any side effects. Participants will also have their blood pressure and pulse rate checked, and laboratory tests will be performed to ensure their well-being. The main goal is to confirm that the healing of erosive esophagitis is maintained over the course of the study. This research aims to provide valuable information on the use of pantoprazole in young patients with this condition.

1 enrollment

Upon joining the study, you will be enrolled after confirming the presence of an erosive lesion in your esophagus. This is done through a procedure called an endoscopy, which involves using a small camera to look inside your esophagus.

If you have already had an endoscopy within the last 12 weeks that confirmed the lesion, you may not need another one immediately. If you have not, an initial endoscopy will be performed to confirm the lesion.

2 healing phase

If you have not completed at least 8 weeks of healing therapy with a proton pump inhibitor (PPI), you will continue this treatment. A PPI is a type of medication that reduces stomach acid, helping to heal the esophagus.

If you are already taking pantoprazole, you will continue with the same dosage. If you are taking a different PPI, it must be approved for use in children and taken according to local guidelines.

3 confirmation of healing

At the end of the 8-week healing phase, a follow-up endoscopy will be performed to confirm that the lesion in your esophagus has healed.

This step is necessary to ensure that the treatment has been effective before moving on to the next phase of the study.

4 maintenance phase

Once healing is confirmed, you will enter the maintenance phase of the study. This phase involves taking the study medication, pantoprazole, in capsule form.

The dosage and frequency of the medication will be determined by the study protocol and will be explained to you by the study team.

5 monitoring and assessments

Throughout the study, your health will be monitored through regular physical examinations, laboratory tests, and assessments of your blood pressure and pulse rate.

You will also be asked to complete an electronic diary to record any symptoms or side effects you experience, as well as your use of the study medication and any rescue medications.

6 end of study

The primary goal of the study is to confirm the maintenance of healing of erosive esophagitis at week 24.

At the end of the study, a final assessment will be conducted to evaluate the outcomes and ensure your safety.

Who Can Join the Study?

Participants must have a documented erosive lesion in the esophagus, which is a sore or damage in the tube that connects the mouth to the stomach. This must be confirmed by a procedure called an EGD (a test where a doctor looks inside the esophagus with a camera).
If the participant has already started treatment with a PPI (a type of medicine that reduces stomach acid) to heal the lesion, they must continue this treatment for up to 8 weeks.
Participants must be able to give signed informed consent or assent, which means they agree to follow the study rules and understand what the study involves.
The participant or their parent/legal guardian must be willing and able to complete an electronic diary and other study-related logs and questionnaires throughout the study.
Participants must be willing and able to attend all scheduled visits, follow the treatment plan, and complete all tests and procedures required by the study.
Participants must be between the ages of 1 and 17 years.
Participants must weigh at least 7 kg (about 15 pounds).
Both male and female participants can join the study. Females who can have children must follow specific study rules, and those who cannot have children must meet certain criteria.

Who Cannot Join the Study?

Participants with any other serious health conditions that might interfere with the study.
Participants who are currently taking medications that could affect the study results.
Participants who have had surgery on their esophagus or stomach.
Participants with a history of drug or alcohol abuse.
Participants who are pregnant or breastfeeding.
Participants who have participated in another clinical trial recently.
Participants with known allergies to the study medication.
Participants who are unable to follow the study procedures.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Univerzitna Nemocnica Martin	Martin	Slovakia
Cliniq s.r.o.	Bratislava	Slovakia
KM Management spol. s r.o.	Nitra	Slovakia
Vrije Universiteit Brussel	Jette	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.12.2023
Slovakia	Not recruiting	01.12.2023

Trial locations

Investigated drugs:

Pantoprazole Sodium Sesquihydrate

Pantoprazole is a medication used in this clinical trial to help maintain the healing of erosive esophagitis in children and teenagers. Erosive esophagitis is a condition where the lining of the esophagus becomes inflamed and damaged due to stomach acid. Pantoprazole works by reducing the amount of acid produced in the stomach, which helps prevent further damage to the esophagus and allows it to heal. This medication is taken orally, meaning it is swallowed in the form of a pill or liquid. The trial is exploring how well pantoprazole works in keeping the esophagus healed in young participants who have already experienced healing from previous treatment.

Erosive Esophagitis – Erosive esophagitis is a condition characterized by inflammation and damage to the lining of the esophagus, often caused by stomach acid reflux. This damage can lead to the formation of erosions or ulcers in the esophageal lining. The progression of the disease involves the worsening of these erosions, which can cause symptoms such as heartburn, difficulty swallowing, and chest pain. Over time, repeated exposure to stomach acid can lead to more severe damage and complications. The condition can fluctuate, with periods of healing and recurrence. It is important to manage the underlying causes to prevent further esophageal damage.

Trial ID:

2023-508770-28-00

Protocol code:

B1791094

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects and Safety of Pantoprazole for Children and Teens with Healed Erosive Esophagitis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?