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

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

5 criteria

  • 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 trial?

7 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Dexlansoprazole – This medication is administered orally in the form of delayed-release capsules. It is currently being studied in clinical trials for its safety and effectiveness in treating symptomatic nonerosive gastroesophageal reflux disease (GERD) in children aged 2 to 11 years. Dexlansoprazole is primarily used to reduce stomach acid and relieve symptoms of GERD. It works by inhibiting the proton pump in the stomach lining, which decreases the production of stomach acid. This medication is classified as a proton pump inhibitor (PPI).

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age0-17PhasePhase IITrial ID2022-501349-64-00Protocol codeTAK-390MR_204Estimated enrolment70 patientsSponsorTakeda Development Center Americas Inc.

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