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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Universita’ Degli Studi Della Campania Luigi Vanvitelli	Naples	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Centro Hospitalar Universitario Sao Joao E.P.E.	Porto	Portugal

Other Sites

Site Name	City	Country
Nosokomeio Paidon I Agia Sofia	Athens	Greece
Hospital Cuf Descobertas S.A.	Lisbon	Portugal
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal
Pneumocare	Namur	Belgium
Hippokration Hospital	Athens	Greece
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Virgen del Rocío University Hospital	Sevilla	Spain
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania
Hospital Da Luz S.A.	Lisbon	Portugal
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Centro Hospitalar Universitario De Santo Antonio E.P.E.	Porto	Portugal
A.O.U. Policlinico G. Martino Di Messina	Messina	Italy
Unidade Local De Saude Do Alto Minho E.P.E.	Ponte De Lima	Portugal
Uvlxmglwdx Dnnux Slfua Dp Rfri Lv Sfgeqxfi	Rome	Italy
Hvlxrlhu Uutpmnikxaeja Hrxgnwqa Tjphk y Podwfp Ipcvrusp Cufskg dqheboksmpnaetzcd (slwb	Badalona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.07.2022
Greece	Not recruiting	01.07.2022
Italy	Not recruiting	01.07.2022
Lithuania	Not recruiting	01.07.2022
Portugal	Not recruiting	01.07.2022
Spain	Not recruiting	01.07.2022

Trial locations

Investigated drugs:

Esomeprazole Magnesium

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.

Investigated diseases:

Erosive oesophagitis

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.

Trial ID:

2023-505454-18-00

Protocol code:

D9612C09998

NCT ID:

NCT05267613

Trial Phase:

Therapeutic confirmatory (Phase III)

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

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