Study on the Safety and Effectiveness of Dexlansoprazole for Treating Nonerosive GERD 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 Gastroesophageal Reflux Disease (GERD) in children aged 2 to 11 years. GERD is a condition where stomach acid frequently flows back into the tube connecting the mouth and stomach, causing discomfort. The study will use a medication called Dexlansoprazole, which is designed to help reduce the symptoms of GERD. The medication is given in the form of a capsule that releases the medicine slowly over time, and it is taken by mouth.

The purpose of this study is to assess the safety and effectiveness of Dexlansoprazole in treating children with GERD. Participants will receive the medication daily for a period of 12 weeks. The study will compare different doses of the medication to see which is most effective in reducing symptoms like stomach pain, burning in the chest or throat, and other related discomforts. Some participants may receive a placebo, which looks like the real medication but does not contain the active ingredient.

Throughout the study, researchers will monitor the participants to see how many days they experience relief from symptoms such as stomach pain, burning sensations, vomiting, and trouble eating. The goal is to find out how well Dexlansoprazole works in improving the quality of life for children with GERD. The study will also look at how the medication affects different age groups within the 2 to 11-year-old range. This information will help doctors understand how to better treat GERD in children.

1 beginning of treatment

The treatment involves taking dexlansoprazole capsules. These are delayed-release capsules, which means they release the medication slowly over time.

The capsules are taken orally, which means they are swallowed.

2 medication dosage and frequency

The dosage of dexlansoprazole can be 15 mg, 30 mg, or 60 mg, depending on the specific needs and characteristics of the patient.

The medication is taken once daily (QD), which means once every day.

3 duration of treatment

The treatment lasts for a total of 12 weeks.

During this period, the effectiveness and safety of the medication are assessed.

4 monitoring symptoms

The primary goal is to monitor the percentage of days without symptoms such as hurting or burning in the stomach, chest, or throat.

Secondary goals include monitoring the percentage of days without vomiting, food coming up from the stomach to the mouth, and trouble eating.

5 end of treatment

At the end of the 12-week period, the treatment concludes.

The results are analyzed to determine the effectiveness of the medication in reducing symptoms.

Who Can Join the Study?

The child must be between 2 to 11 years old.
The child must have a history of GERD symptoms for at least 3 months before the study starts. GERD stands for Gastroesophageal Reflux Disease, which is when stomach acid frequently flows back into the tube connecting your mouth and stomach.
The child must have reported symptoms like hurting 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.
The child should not have any signs of erosive esophagitis. This means there should be no damage to the esophagus, which is the tube that carries food from the mouth to the stomach. The doctor may use a test called 24-hour pH-metry to check if the symptoms are related to acid. This test measures the amount of acid in the esophagus over a 24-hour period.
Both boys and girls can participate in the study.

Who Cannot Join the Study?

Children who are not between the ages of 2 to 11 years cannot participate.
Children who do not have symptomatic nonerosive GERD cannot participate. GERD stands for Gastroesophageal Reflux Disease, which is a condition where stomach acid frequently flows back into the tube connecting your mouth and stomach.
Children who have any other medical conditions that might interfere with the study cannot participate.
Children who are taking medications that might affect the study results cannot participate.
Children who have participated in another clinical trial recently cannot participate.
Children who have allergies to the study medication or similar medications cannot participate.
Children who have any serious health issues that might make it unsafe for them to participate cannot participate.

Where you can join this trial?

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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 study to treat children aged 2 to 11 years who have symptoms of nonerosive gastroesophageal reflux disease (GERD). It is taken by mouth in the form of delayed-release capsules. The purpose of using this medication in the trial is to evaluate its safety and effectiveness in reducing the symptoms associated with GERD in the pediatric population.

Gastroesophageal Reflux Disease (GERD) – This condition occurs when stomach acid frequently flows back into the tube connecting your mouth and stomach, known as the esophagus. In children, it can cause symptoms such as heartburn, a burning sensation in the chest or throat, and regurgitation of food or sour liquid. Unlike erosive GERD, nonerosive GERD does not cause visible damage to the esophagus lining. Symptoms can vary in intensity and may be more noticeable after eating or when lying down. Over time, GERD can lead to discomfort and may affect eating habits. It is important to manage symptoms to improve quality of life and prevent potential complications.

Trial ID:

2022-501349-64-00

Protocol code:

TAK-390MR_204

NCT ID:

NCT02616302

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Dexlansoprazole for Treating Nonerosive GERD in Children Aged 2 to 11 Years

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?