A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age
Erosive esophagitis happens when stomach acid repeatedly splashes up into the food pipe (oesophagus), causing redness, swelling, and small, painful breaks in the lining. This Phase 3 clinical trial is testing a medicine called Nexium (esomeprazole) in children aged 1 to 11 years. The trial tests Nexium granules, which mix with water into an easy-to-swallow drink. The study has two main steps: an 8-week healing stage to see if the medicine clears up the sores, followed by a 16-week maintenance stage to see if it stops the damage from returning. Doctors will carefully check the children's progress using camera tests (endoscopies), routine blood tests, and health checks such as weight and blood pressure. The goal is to confirm whether Nexium is safe, gentle, and effective at keeping young children free from acid damage over several months.
At a glance
What is this study about?
When we eat, food travels down a tube called the food pipe (or oesophagus) into the stomach. The stomach produces strong acid to digest meals. In some children, this acid leaks back upwards, a problem known as acid reflux. If acid splashes up often, it can irritate the delicate lining of the food pipe and create small raw patches or ulcers. Doctors call this condition erosive esophagitis. It can cause chest discomfort, tummy pain, feeding problems, and pain when swallowing.
This clinical study is testing a treatment called Nexium (esomeprazole). Nexium belongs to a family of medicines called proton pump inhibitors. These work by turning down the amount of acid the stomach produces, giving the lining of the food pipe a chance to recover. In this trial, the medicine comes as tiny coated granules inside a sachet, which can be mixed with water to make it much easier for young children to take.
The research is split into two phases. First, children take the medicine for 8 weeks to see if their sores heal completely. After that, they continue taking the medicine for another 16 weeks to see if it keeps the food pipe healthy and prevents the inflammation from coming back. Because children's bodies process medicines differently from adults, trials like this are essential to confirm the safest and most effective doses for younger patients.
Key takeaways
- Tests Nexium granules in children aged 1 to 11 with acid-damaged food pipes.
- Checks both short-term healing (8 weeks) and long-term protection (16 weeks).
- Uses child-friendly drinkable granules rather than hard-to-swallow tablets.
- Monitors healing using gentle camera checks (endoscopies) and routine health visits.
- Participation is entirely voluntary and parents may withdraw at any time.
Who may be eligible?
This study is aimed at boys and girls aged between 1 and 11 years who have been diagnosed with erosive esophagitis linked to acid reflux.
To be considered, children must be able to swallow the liquid medicine prepared from the sachets, and their parents or guardians must give full written permission. A doctor will confirm whether the child has active irritation or sores in their food pipe before they can join the trial.
Children may not be suitable for the study if they have other major digestive disorders, severe allergies to acid-reducing medications, or other serious health conditions that could make taking part unsafe. The study doctor will check every child's full medical history to make sure taking part is appropriate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- My child is between 1 and 11 years old.
- My child has signs or a diagnosis of erosive esophagitis (acid damage in the food pipe).
- My child can take liquid or granule-based medicines by mouth.
- We are willing and able to attend hospital clinic check-ups over 24 weeks.
- A parent or legal guardian is willing to give informed consent.
What does participation involve?
Taking part in this trial lasts for around 24 weeks (about 6 months) in total. Children will take Nexium granules once a day, mixed into a small drink. During the study, parents will bring their child to the hospital clinic for regular monitoring visits. Doctors will check vital signs such as pulse, blood pressure, and weight, and carry out routine blood and urine tests. To see how the food pipe is healing, children will have an endoscopy (a quick camera check inside the food pipe, usually done while the child is asleep under general anaesthetic or sedation) at the end of the 8-week healing stage and again at the end of the 16-week maintenance stage. Parents will also keep track of any flare-up symptoms and any extra heartburn relief medicines used at home.
Potential risks and benefits
Locations (6)
- —UnverifiedGreece
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedLithuania
- —UnverifiedPortugal
Common questions
How does my child take the medicine?
The medicine comes in small sachets of granules that are stirred into water to create a liquid suspension, making it easy for young children to drink.
Will the camera test (endoscopy) hurt my child?
No. In young children, endoscopies are typically performed under sedation or a light general anaesthetic so they stay comfortable, feel no pain, and do not remember the procedure.
Can my child still take other heartburn medicines if symptoms get bad?
Yes. The study team can provide approved 'rescue' medications to ease symptoms if needed, and parents will simply record whenever these are used.
Does taking part cost anything?
No. The trial medication, clinic visits, and all health tests are provided free of charge, and travel expenses for hospital visits are often reimbursed.
What happens if we decide to stop during the study?
You are free to leave the trial at any time. Your decision will never change or affect the quality of normal medical care your child receives.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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