What side effects are associated with this type of intervention?

Proton Pump Inhibitors (PPIs) like Dexlansoprazole, Lansoprazole, and Omeprazole are commonly used to treat acid reflux by reducing stomach acid production. Common side effects of PPIs include headache, diarrhea, constipation, nausea, and abdominal pain. Long-term use may be associated with an increased risk of fractures, kidney disease, and vitamin B12 deficiency. Bile acid binders, used in refractory GERD, can cause constipation. Acupuncture, an alternative treatment, has minimal side effects but requires further study to confirm its efficacy.

What prior FDA approvals exist?

Proton pump inhibitors (PPIs) like Dexlansoprazole have been widely approved by the FDA for the treatment of acid reflux and GERD. Other PPIs include Omeprazole, Lansoprazole, Esomeprazole, Pantoprazole, and Rabeprazole. These medications work by reducing the production of stomach acid, thereby alleviating symptoms of heartburn and promoting healing of the esophagus. Studies have shown that PPIs are effective in managing GERD symptoms and healing erosive esophagitis, with Dexlansoprazole offering extended pharmacodynamic effects and improved convenience for patients.

What other types of research exist?

Promising alternatives to Dexlansoprazole for acid reflux treatment include: 1) CDFR0209, a combination of immediate-release omeprazole and sodium bicarbonate, which has shown effective acid inhibition. 2) Ilaprazole, a new PPI that has demonstrated ulcer-healing effects. 3) Non-PPI options like laparoscopic fundoplication for refractory cases. These alternatives offer different mechanisms and potential benefits for managing acid reflux.

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Proton Pump Inhibitor

Dexlansoprazole for Acid Reflux in Children

Phase 2

Recruiting

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Has a medical history of at least 1 failed attempted withdrawal of prior proton pump inhibitor (PPI)/acid-suppressive therapy and a return of symptoms upon withdrawal

Male or female aged 2 to 11 years at the time of screening informed consent

Must not have

Requires dilatation of esophageal strictures and/or strictures preventing passage of the endoscope during the screening endoscopy

History of celiac disease, tests positive for tissue transglutaminase (tTG) antibody or confirmed disease by histology

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests Dexlansoprazole, a medication that reduces stomach acid, in children aged 2 to 11 years with nonerosive GERD. The study aims to see how effective the drug is and what side effects it might have. Participants will take the medication daily for a few months and record their symptoms. Dexlansoprazole is used to treat gastroesophageal reflux disease (GERD).

Who is the study for?

This trial is for children aged 2 to 11 with nonerosive gastroesophageal reflux disease (GERD) that causes symptoms like heartburn. They should have a history of GERD symptoms for at least 3 months and previous unsuccessful attempts to stop acid-suppressive therapy. Kids with severe allergies, certain gastrointestinal conditions, or who need excluded medications can't participate.

What is being tested?

The study tests the safety and effectiveness of Dexlansoprazole capsules in treating GERD symptoms in kids. Participants will take the medication orally once daily for 12 weeks to see if it helps reduce their discomfort without causing harm.

What are the potential side effects?

Possible side effects from Dexlansoprazole may include headache, stomach pain, diarrhea, vomiting, gas, nausea, and upper respiratory tract infection. However, individual reactions can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I tried stopping my acid reflux medication before, but my symptoms came back.

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I am between 2 and 11 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need a procedure to widen my esophagus to allow an endoscope to pass.

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I have been diagnosed with celiac disease.

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I have a history of inflammatory or irritable bowel disease.

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I am a woman and have had my first menstrual period.

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I have or had a condition that causes excessive stomach acid.

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I have not had major stomach or esophagus surgery, except for ulcer repair.

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I haven't donated blood, had a transfusion, or undergone plasmapheresis in the last 3 months.

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I have Barrett's esophagus with changes in my esophagus cells.

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I am allergic to dexlansoprazole or similar heartburn medications.

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I don't need to take any medications that aren't allowed in the study.

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I have not had any diseases, treatments, or injuries to my esophagus.

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I have been diagnosed with or show signs of eosinophilic esophagitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over the 12 Weeks of Treatment

Secondary study objectives

Difference of the Median Percentage of Days Without Hurting or Burning in the Stomach, Chest, or Throat Over the 12 Weeks of Treatment Between the High Dose and the low Dose Within Each Weight Strata

Percentage of Days Food Did Not Come Up from Stomach to Mouth Over the 12 Weeks of Treatment

Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat in Children Aged 2 to 8 Years Over the 12 Weeks of Treatment

+3 more

Side effects data

From 2016 Phase 4 trial • 296 Patients • NCT02351960

Headache

Diarrhoea

100%

80%

60%

40%

20%

Study treatment Arm

Dexlansoprazole 30 mg

Dexlansoprazole 60 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Weight ≤30 kg: Dexlansoprazole 30 mgExperimental Treatment1 Intervention

Dexlansoprazole 30 mg, capsules, once, daily, for 12 weeks. Participants weigh ≤30 kg.

Group II: Weight ≤30 kg: Dexlansoprazole 15 mgExperimental Treatment1 Intervention

Dexlansoprazole 15 mg, capsules, once, daily, for 12 weeks. Participants weigh ≤30 kg.

Group III: Weight >30 kg: Dexlansoprazole 60 mgExperimental Treatment1 Intervention

Dexlansoprazole 60 mg, capsules, once, daily, for 12 weeks. Participants weigh \>30 kg.

Group IV: Weight >30 kg: Dexlansoprazole 30 mgExperimental Treatment1 Intervention

Dexlansoprazole 30 mg, capsules, once, daily, for 12 weeks. Participants weigh \>30 kg.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexlansoprazole

2010

Completed Phase 4

~1290

0 / 14Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Proton Pump Inhibitors (PPIs), such as Dexlansoprazole, work by irreversibly blocking the hydrogen-potassium ATPase enzyme system (the proton pump) of the gastric parietal cells, thereby reducing the production of stomach acid. This reduction in acid helps to alleviate symptoms and promote healing of the esophagus. H2 receptor antagonists, like ranitidine, reduce acid production by blocking histamine receptors on acid-producing cells in the stomach. Antacids neutralize existing stomach acid, providing quick relief from symptoms. Prokinetics, such as metoclopramide, enhance gastrointestinal motility, helping to clear stomach contents more efficiently and reduce reflux episodes. Understanding these mechanisms is crucial for acid reflux patients as it helps in selecting the most appropriate treatment to manage their symptoms effectively.

Antacid therapy for gastroesophageal reflux in preterm infants: a systematic review.The effects of baclofen for the treatment of gastroesophageal reflux disease: a meta-analysis of randomized controlled trials.