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Study on Esomeprazole Magnesium for Maintaining Healing of Erosive Esophagitis in Children Aged 1 to 11 Years

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the condition known as erosive esophagitis, which is a form of inflammation and damage to the esophagus, the tube that carries food from the mouth to the stomach. The study is specifically looking at children aged 1 to 11 years who have this condition. The treatment being tested is called NEXIUM, which contains the active ingredient esomeprazole magnesium. This medication is designed to help maintain the healing of the esophagus after it has been treated for erosive esophagitis.

The purpose of the study is to assess how effective and safe NEXIUM is in keeping the esophagus healed in young patients. Participants in the study will receive the medication in the form of an oral suspension, which is a liquid form that is easy to swallow. The study will take place over a period of several weeks, during which time the children will be monitored to see if their esophagus remains healed and to check for any side effects from the medication.

Throughout the study, the children will have regular check-ups to ensure their safety and to evaluate the condition of their esophagus. The study aims to provide valuable information on how well NEXIUM works in maintaining the healing of erosive esophagitis in children, which could help improve treatment options for this condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
The study involves children aged 1 to 11 years with a history of gastroesophageal reflux disease (GERD) for at least 3 months.
Participants must have confirmed erosive esophagitis (EE) through an endoscopy performed within one week before starting the healing phase.
Step 2
Healing phase
Participants receive NEXIUM (esomeprazole magnesium) in the form of gastro-resistant granules for oral suspension.
The healing phase lasts for 8 weeks, during which the presence or absence of EE is assessed through endoscopy.
The percentage of days without the need for additional medication is recorded.
Step 3
End of healing phase assessment
An endoscopy is performed to verify the healing of EE.
Participants must have healed EE to proceed to the maintenance phase.
Step 4
Maintenance phase
Participants continue to receive NEXIUM for 16 weeks to maintain the healing of EE.
The presence or absence of EE is assessed at the end of this phase through endoscopy.
The percentage of days without the need for additional medication is recorded.
Step 5
Safety and tolerability assessment
Throughout the trial, safety and tolerability are evaluated by monitoring adverse events, vital signs, and laboratory variables.
Vital signs include blood pressure, pulse, and body weight.

Who can join the trial?

8 criteria

The patient must be between 1 to 11 years old when their guardian signs the informed consent, and the patient signs the informed assent if needed.
The patient must have a history of **GERD** (Gastroesophageal Reflux Disease) for at least 3 months before starting the study treatment, as determined by the study doctor.
For the healing phase, the patient must have confirmed **Erosive Esophagitis** (EE) through an endoscopy done within one week before starting the healing phase. An endoscopy is a procedure where a doctor uses a special camera to look inside the esophagus.
For the maintenance phase, the patient must have completed the healing phase and have endoscopy-confirmed healed EE, meaning no signs of the condition at the 8-week endoscopy visit.
The patient must weigh at least 10 kg (about 22 pounds).
The patient can be either male or female.
All female patients who have started menstruating must have a negative pregnancy test before starting treatment. If they are sexually active, they must either not engage in sexual activity or use effective birth control methods from the day of informed consent until the last day of treatment. They must agree to use two medically accepted methods of birth control, with at least one being highly reliable, such as birth control pills, implants, patches, injections, or an intrauterine device. The other method must be a barrier method, like a diaphragm with spermicide or a male condom with spermicide. Before menstruation starts, pregnancy testing is not needed, but the patient and their guardian must be informed that once menstruation begins, pregnancy testing and possibly starting birth control will be required.
The patient's guardian must be able to give signed informed consent, which means they agree to follow the study's requirements and restrictions. Patients who are old enough to understand the study will also sign an assent form, according to local rules.

Who cannot join the trial?

7 criteria

Patients who do not have **Erosive Esophagitis**. This is a condition where the lining of the esophagus, the tube that carries food from the mouth to the stomach, is damaged by stomach acid.
Patients who are not between 1 to 11 years of age.
Patients who are not able to follow the study procedures or take the study medication as required.
Patients who have other medical conditions that might interfere with the study or make it unsafe for them to participate.
Patients who are taking other medications that might interfere with the study medication.
Patients who have had a recent surgery or medical procedure that might affect the study results.
Patients who are part of a vulnerable population, meaning they might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Nosokomeio Paidon I Agia Sofia
Responsive
Athens, Greece
Pneumocare
Responsive
Namur, Belgium
Universita Degli Studi Di Roma La Sapienza
Responsive
Rome, Italy

Trial locations

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Investigated drugs

NEXIUM is a medication used in this clinical trial to help maintain the healing of erosive esophagitis in children aged 1 to 11 years. Erosive esophagitis is a condition where the lining of the esophagus becomes inflamed and damaged due to stomach acid. **NEXIUM** works by reducing the amount of acid produced in the stomach, which helps to heal the esophagus and prevent further damage. The trial aims to evaluate how effective and safe **NEXIUM** is for long-term use in maintaining the healing of this condition in young patients.

Esomeprazole Magnesium

What is already known about the treatment

Nexium – Nexium is administered orally, typically in the form of tablets or capsules. It is currently well-established in medical literature as a treatment for conditions like erosive esophagitis. The main therapeutic indication for Nexium is the maintenance of healing in erosive esophagitis, particularly in pediatric patients aged 1 to 11 years. At the molecular level, Nexium works by inhibiting the proton pump in the stomach lining, reducing the production of stomach acid. It is classified pharmacologically as a proton pump inhibitor.

Investigated diseases

Erosive Esophagitis – Erosive Esophagitis is a condition where the lining of the esophagus becomes inflamed and eroded due to stomach acid. This can lead to symptoms such as heartburn, difficulty swallowing, and chest pain. The disease progresses as the acid continues to damage the esophageal lining, potentially leading to ulcers or strictures. Over time, repeated exposure to stomach acid can cause more severe damage to the esophagus. The condition is often associated with gastroesophageal reflux disease (GERD), where stomach acid frequently flows back into the esophagus. Management typically involves lifestyle changes and medications to reduce acid production.