Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

AN EXPLORATORY, MULTICENTER, RANDOMIZED,DOUBLE BLIND STUDY OF CLINICAL OUTCOMES,TOLERABILITY, AND SAFETY OF 2 DOSES OF ORAL PANTOPRAZOLE IN PEDIATRIC PARTICIPANTS AGED 1 TO 11 YEARS AND 12 TO 17 YEARS WHO REQUIRE MAINTENANCE THERAPY FOR HEALED EROSIVE ESOPHAGITIS

This study is looking into a medicine called pantoprazole for children aged 1 to 17. These children have had a condition called erosive oesophagitis, where the tube that carries food to the stomach (oesophagus) gets inflamed and sore. They've already been treated and their oesophagus has healed. The study wants to find out if taking pantoprazole at different doses can stop the soreness from coming back. Researchers will also check how well children tolerate the medicine and if there are any side effects. The study compares pantoprazole to a dummy pill (placebo) and will last for 24 weeks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Pfizer Inc.

Enrolment target

Start

20 Dec 2023

EROSIVE ESOPHAGITIS

What is this study about?

Imagine the tube that carries food from your mouth to your tummy – that's called your oesophagus or food pipe. Sometimes, this tube can get sore and inflamed, a condition known as erosive oesophagitis. This study is for children and teenagers aged 1 to 17 who have had this problem, but their food pipe has since healed.

The main goal of this research is to see if a medicine called pantoprazole can help keep the oesophagus healthy and prevent the soreness from returning. We want to find out which dose works best and if it's safe for children to take long-term. Currently, we're in an early stage of testing this medicine for this specific purpose.

To do this, some children will receive different doses of pantoprazole, while others will receive a 'dummy' pill (placebo), which looks exactly like the real medicine but contains no active drug. This allows us to fairly compare the effects of the medicine. The study will carefully check inside the oesophagus to see if it remains healed.

Key takeaways

This study is for children aged 1-17 with a healed food pipe condition.
It tests a medicine called pantoprazole to prevent soreness from returning.
The study compares different doses to a dummy pill (placebo).
It will check safety and how well the medicine is tolerated.
The study involves regular clinic visits and tests over 24 weeks.

Who may be eligible?

This study is open to children and young people of all genders, from 1 year old up to 17 years old. The most important thing is that they have previously been diagnosed with a condition called erosive oesophagitis, and that their food pipe (oesophagus) has now healed well.

The research team will need to confirm that their oesophagus is healed by looking inside it with a small camera (a procedure called an endoscopy). There will also be other health checks to make sure the child is suitable and healthy enough to take part safely. Only those who meet all specific health criteria set by the researchers can join.

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.

Is your child between 1 and 17 years old?
Has your child been diagnosed with erosive oesophagitis in the past?
Has their oesophagus now healed from this condition?
Is your child generally in good health otherwise?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will receive either the study medicine, pantoprazole, or a matching dummy pill (placebo) every day. This will be given as small granules in special capsules. You won't know which one your child is receiving.

Over 24 weeks (about 6 months), your child will have several visits to the clinic. During these visits, doctors will perform physical examinations and monitor their blood pressure and pulse. There will also be blood tests to check their general health. Importantly, a scope will be used to look inside their food pipe at the beginning and end of the study to confirm how well it has healed.

Throughout the study, you'll be asked to keep track of any side effects or changes in your child's health. The study team will provide clear instructions and support every step of the way. You can expect regular contact and checks to ensure your child's well-being.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. Your child might benefit from a medication that effectively keeps their oesophagus healed, which could improve their comfort and health. However, as with any medicine, there's a chance of side effects, which the study will carefully monitor. Remember, you have the right to withdraw your child from the study at any time, for any reason, without it affecting their usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Slovakia
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Unverified
Belgium

Common questions

What is erosive oesophagitis?

It's when the tube from your mouth to your tummy (oesophagus) gets sore and inflamed, often due to stomach acid.

What is pantoprazole?

It's a medicine often used to reduce stomach acid, which can help healing in conditions like oesophagitis.

What does 'double blind' mean in a study?

It means neither you nor the doctors know if your child is getting the real medicine or a dummy pill (placebo), to make the results fairer.

How long will the study last?

The treatment part of the study will last for 24 weeks, which is about six months.

Will my child need any special tests?

Yes, they will have physical exams, blood tests, and a special test called an endoscopy, where a thin tube with a camera looks inside their food pipe.