Study on Dexlansoprazole for Treating and Maintaining Healing of Erosive Esophagitis in Children Aged 2 to 11 Years

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What is this study about?

This clinical trial is focused on studying a condition known as Erosive Esophagitis in children aged 2 to 11 years. Erosive Esophagitis is a condition where the lining of the esophagus, the tube that carries food from the mouth to the stomach, becomes inflamed and damaged. The study will use a medication called Dexlansoprazole, which is taken orally in the form of a capsule. Dexlansoprazole is designed to help heal the esophagus and maintain its healing over time.

The purpose of the study is to evaluate the safety and effectiveness of Dexlansoprazole in healing Erosive Esophagitis and maintaining the healing in children. Participants will take the medication daily for a period of up to 36 weeks. The study will be conducted in two phases: the first phase will focus on healing the esophagus over 8 weeks, and the second phase will focus on maintaining the healing for an additional 16 weeks. Some participants may receive a placebo during the study.

Throughout the study, participants will be monitored to assess the healing of the esophagus and to ensure the medication is safe for use in children. The study aims to provide valuable information on how well Dexlansoprazole works in treating Erosive Esophagitis in young patients and to ensure it is a safe treatment option. Participants will be required to visit the study site for regular check-ups and assessments during the trial period.

1 initial treatment phase

The study begins with an initial treatment phase lasting 8 weeks.

During this phase, the medication dexlansoprazole is administered orally once a day.

The dosage is either 30 mg or 60 mg, depending on the specific requirements of the study.

The goal is to heal erosive esophagitis (EE), a condition where the lining of the esophagus is inflamed and eroded.

2 assessment of healing

At the end of the 8-week initial treatment phase, an endoscopy is performed.

This procedure checks the healing progress of the esophagus.

The primary aim is to determine the percentage of participants who have achieved healing of EE by this time.

3 maintenance phase

Participants who have healed EE enter a maintenance phase lasting 16 weeks.

During this phase, dexlansoprazole is administered orally once a day.

The dosage is adjusted to either 15 mg or 30 mg, based on the study’s requirements.

The objective is to maintain the healing of the esophagus.

4 final assessment

At the end of the 16-week maintenance phase, another endoscopy is conducted.

This assessment determines the percentage of participants who have maintained healed EE throughout the maintenance phase.

The study also evaluates the percentage of days participants experienced no symptoms such as hurting or burning in the stomach, chest, or throat.

Who Can Join the Study?

Children aged between 2 to 11 years can participate.
Both boys and girls are eligible.
The child must have a medical history of GERD symptoms for at least 3 months before the screening. GERD stands for Gastroesophageal Reflux Disease, which is when stomach acid frequently flows back into the tube connecting your mouth and stomach.
The child should have reported symptoms of pain or burning in the stomach, chest, or throat on at least 3 out of any 7 consecutive days during the screening period. These symptoms should be recorded in an electronic diary.
There must be endoscopic evidence of EE. EE stands for Erosive Esophagitis, which is irritation or inflammation of the esophagus, the tube that carries food from the mouth to the stomach. This evidence should be based on an endoscopy, a procedure where a doctor uses a flexible tube with a camera to look inside the esophagus, performed during the screening period or within 1 week before signing the screening consent forms.

Who Cannot Join the Study?

Patients who are not between the ages of 2 to 11 years cannot participate.
Patients who do not have a condition called erosive esophagitis cannot participate. This is a condition where the lining of the esophagus, the tube that carries food from the mouth to the stomach, is damaged.
Patients who are not able to take the study medication as prescribed cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate.
Patients who are taking other medications that might interfere with the study cannot participate.
Patients who have participated in another clinical trial recently cannot participate.
Patients who are not able to follow the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
In Vivo Sp. z o.o.	Bydgoszcz	Poland
MD Korczowski Bartosz Gabinet Lekarski	Rzeszow	Poland

Trial status

Country	Status	Recruitment Start
Poland	Not recruiting	20.05.2022

Trial locations

Investigated drugs:

Dexlansoprazole

Dexlansoprazole is a medication used in this clinical trial to help heal erosive esophagitis (EE) in children aged 2 to 11 years. It is taken by mouth once a day and works by reducing the amount of acid in the stomach, which helps heal the esophagus and relieve symptoms like heartburn. The trial aims to determine how safe and effective this medication is for healing EE over an 8-week period.

In addition to healing EE, Dexlansoprazole is also being tested for its ability to maintain the healing of the esophagus over a longer period. After the initial healing phase, the medication is used to keep the esophagus healthy and prevent the return of symptoms for an additional 16 weeks. This part of the trial focuses on ensuring that the medication continues to be safe and effective for longer-term use in children.

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, chest pain, and difficulty swallowing. The disease progresses as the acid continues to damage the esophageal lining, potentially leading to ulcers or bleeding. Over time, the inflammation can cause scarring and narrowing of the esophagus, which may result in further swallowing difficulties. 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 and promote healing.

Trial ID:

2022-501350-11-00

Protocol code:

TAK-390MR_205

NCT ID:

NCT02615184

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Dexlansoprazole for Treating and Maintaining Healing of Erosive Esophagitis in Children Aged 2 to 11 Years

What is this study about?

Who Can Join the Study?

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