Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Double-Blind, 36-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis (EE) and Maintenance of Healed EE in Pediatric Subjects Aged 2 to 11 Years With EE

This clinical trial is investigating a medicine called dexlansoprazole, given as a capsule once a day, for children between 2 and 11 years old. These children have a condition called 'erosive oesophagitis' (EE), which means the tube connecting their mouth to their stomach (gullet or oesophagus) is inflamed and sore. The main aim is to find out if this medicine can effectively heal the sores in the gullet and then keep them healed for a longer period. Researchers are also checking how safe the medicine is for children. They will be looking at how many children's gullets heal after 8 weeks and how many stay healed for another 16 weeks, along with how often children feel stomach, chest, or throat pain.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Takeda Development Center Americas Inc.

Enrolment target

Start

05 Apr 2024

Erosive Esophagitis

What is this study about?

This study is testing a medication called dexlansoprazole in children aged 2 to 11 who have a condition called erosive oesophagitis (EE). You might know EE as a sore or inflamed gullet, which is the tube that carries food from your mouth to your stomach. This soreness can cause pain and discomfort, often feeling like heartburn.

The main purpose of this research is to see how well dexlansoprazole works in healing these sores in children's gullets and then preventing them from coming back. The study will also carefully look at the safety of this medicine for children. Doctors want to understand if daily doses of this medicine can provide long-lasting relief and healing.

Finding effective and safe treatments for children with EE is really important because it can significantly improve their quality of life, making eating and daily activities much more comfortable. This study aims to add to our knowledge and help doctors make the best decisions for young patients with this condition.

Key takeaways

A study for children aged 2-11 with a sore gullet (erosive oesophagitis).
Testing a daily medicine called dexlansoprazole to heal and keep the gullet healthy.
The study is 'double-blind' – neither you nor the doctors know if it's the real medicine or not.
Participation involves daily medicine, regular clinic visits, and check-ups including some camera tests.
Aims to understand if this medicine is safe and effective for children.

Who may be eligible?

To be considered for this study, children must be between 2 and 11 years old and have been diagnosed with erosive oesophagitis.

Your child's doctor will need to confirm the diagnosis of erosive oesophagitis. There might be other specific health requirements or conditions that your child would need to meet, or not meet, to take part. The study team will discuss all these details with you thoroughly.

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 2 and 11 years old?
Has a doctor told you your child has 'erosive oesophagitis' (a sore gullet)?
Are you able to attend regular clinic visits with your child?
Are you comfortable with your child potentially having camera tests (endoscopies)?

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 (dexlansoprazole) or a dummy medicine (placebo) every day for up to 36 weeks. The study is 'double-blind,' which means neither you nor the doctors will know whether your child is getting the actual medicine or the dummy medicine until the study is over.

Your child will have regular visits to the clinic, which will include examinations and possibly procedures like an endoscopy (a small camera test to look at the gullet) to check how well the gullet is healing. They will also be monitored for any side effects and you might be asked to keep a diary of any tummy, chest, or throat pain your child experiences. The total study duration will be about 36 weeks.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving a new medicine that could help heal your child's gullet and reduce pain. However, there's also a chance your child might receive a dummy medicine, or the study medicine might not work for them. All medicines carry potential risks and side effects, which the study team will explain in detail. You will be closely monitored for any problems. Remember, your child can leave the study at any time, for any reason, without it affecting their usual medical care.

Locations (1)

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

—
Unverified
Poland

Common questions

What is erosive oesophagitis?

It's a condition where the tube connecting your mouth to your stomach (the gullet or oesophagus) becomes sore and inflamed, often causing pain or heartburn.

What does 'double-blind' mean?

It means that neither you nor the study doctors will know if your child is receiving the actual medicine or a dummy medicine until the study is finished.

How long will the study last?

Your child's participation in the study will last for about 36 weeks.

Will my child need any special tests?

Yes, they will likely have regular check-ups and may need an endoscopy, which is a key way to check the healing of the gullet.

Can my child stop taking part if we change our minds?

Absolutely, yes. You can withdraw your child from the study at any time, for any reason, and it won't affect their regular medical care.