Dexlansoprazole for Acid Reflux in Children

Recruiting in Palo Alto (17 mi)

+27 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Takeda

Must not be taking: Antacids, PPIs

Disqualifiers: Cardiovascular, Pulmonary, CNS, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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).

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but it mentions that participants cannot take certain excluded medications during the study. It's best to discuss your current medications with the study team to see if they are allowed.

What data supports the effectiveness of the drug Dexlansoprazole for treating acid reflux in children?

Dexlansoprazole is effective in treating gastroesophageal reflux disease (GERD) by healing erosive esophagitis and maintaining its healing, as well as relieving heartburn symptoms. It has been shown to be safe and effective in adolescents, and its dual delayed-release formulation provides prolonged acid suppression, which is beneficial for managing GERD symptoms. ^{1 2 3 4 5}

Is dexlansoprazole safe for children with acid reflux?

Dexlansoprazole has been studied in children and adolescents for acid reflux and is generally well tolerated, with safety data showing it is safe for use in patients aged 12 and older. ^{1 3 4 5 6}

What makes the drug Dexlansoprazole unique for treating acid reflux in children?

Dexlansoprazole is unique because it has a dual delayed-release formulation that allows it to provide prolonged acid suppression, making it effective for treating and maintaining healing in erosive esophagitis and non-erosive reflux disease. It can be taken once daily and is effective regardless of meal times, offering convenience and flexibility for children. ^{1 2 4 5 6}

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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.

Inclusion Criteria

Has met the eDiary qualification criteria as assessed by the PGSDD

Has no evidence of erosive esophagitis (EE) according to the Los Angeles (LA) Classification of Esophagitis

I have had symptoms of acid reflux for at least 3 months.

Exclusion Criteria

Known history of alcohol abuse or illegal drug use within the past 12 months prior to the first dose of study drug

I might need surgery that requires a hospital stay during the study.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Multiple visits (in-person)

Treatment

Participants receive daily oral administration of dexlansoprazole for 12 weeks

12 weeks

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

1 phone call

Treatment Details

Interventions

• Dexlansoprazole (Proton Pump Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Weight ≤30 kg: Dexlansoprazole 30 mg Experimental Treatment 1 Intervention

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

Group II: Weight ≤30 kg: Dexlansoprazole 15 mg Experimental Treatment 1 Intervention

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

Group III: Weight >30 kg: Dexlansoprazole 60 mg Experimental Treatment 1 Intervention

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

Group IV: Weight >30 kg: Dexlansoprazole 30 mg Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Findings from Research

In a 36-week study involving 62 adolescents aged 12-17 with erosive esophagitis (EE), dexlansoprazole demonstrated a high healing rate of 88% and maintained healing in 82% of patients during the maintenance phase.

The treatment was generally safe, with 61.3% of patients reporting treatment-emergent adverse events (TEAEs), the most common being headache and oropharyngeal pain, indicating that while side effects occurred, they were manageable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dual Delayed-Release Dexlansoprazole for Healing and Maintenance of Healed Erosive Esophagitis: A Safety Study in Adolescents. Gremse, D., Gold, BD., Pilmer, B., et al.[2020]

Dexlansoprazole ODT shows equivalent bioavailability in both fed and fasted states, although the maximum concentration (Cmax) is lower in the fed state, indicating that food intake can affect peak drug levels.

Different administration routes, including oral syringe and nasogastric tube, provide similar systemic exposure to dexlansoprazole as the standard ODT method, ensuring flexibility in how the medication can be given.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bioavailability of a dexlansoprazole delayed-release orally disintegrating tablet: effects of food and mode of administration. Kukulka, M., Nudurupati, S., Perez, MC.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Dual Delayed-Release Dexlansoprazole for Healing and Maintenance of Healed Erosive Esophagitis: A Safety Study in Adolescents. [2020]

2. Poland pubmed.ncbi.nlm.nih.gov

Dexlansoprazole - a new-generation proton pump inhibitor. [2020]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and safety of dexlansoprazole MR in pediatric patients with symptomatic gastroesophageal reflux disease. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

Dexlansoprazole for the treatment of esophagitis and GERD. [2017]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Dexlansoprazole modified release: in erosive oesophagitis and non-erosive reflux disease. [2021]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Bioavailability of a dexlansoprazole delayed-release orally disintegrating tablet: effects of food and mode of administration. [2020]