Dexlansoprazole for Acid Reflux in Children

Recruiting at 34 trial locations

Overseen By Takeda Contact

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Must not be taking: Antacids, PPIs

Disqualifiers: Cardiovascular, Pulmonary, CNS, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 12 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the medication dexlansoprazole can help children with acid reflux symptoms, such as heartburn, without visible esophageal damage. Dexlansoprazole has already proven effective in adults and teens, and the study aims to determine if it also benefits children. Children who have experienced acid reflux symptoms, like burning in the stomach or throat, for at least three months without esophageal damage may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering children the opportunity to potentially benefit from this medication.

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.

Is there any evidence suggesting that dexlansoprazole is likely to be safe for children?

Research has shown that dexlansoprazole is generally safe and well-tolerated for treating acid-related issues like GERD in adults and teens. Studies involving over 4,500 participants have demonstrated its safety for up to four weeks of use. The FDA has approved dexlansoprazole for treating heartburn and similar conditions, indicating a strong safety record.

Common side effects include diarrhea, stomach pain, and nausea, which are usually mild and short-lived. Serious side effects are rare. The current trial is in a phase that evaluates both safety and effectiveness, meaning earlier studies have already shown enough safety to test dexlansoprazole in children with GERD.

For those considering joining the trial, it is important to know that many people have used dexlansoprazole safely. However, always consult a healthcare provider to understand all the risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for acid reflux?

Researchers are excited about dexlansoprazole for treating acid reflux in children because it offers a novel approach compared to standard proton pump inhibitors like omeprazole or lansoprazole. Dexlansoprazole uses a dual delayed-release mechanism, which means it provides two releases of medication at different times to extend acid control throughout the day. This unique feature might allow for better symptom management and convenience with once-daily dosing. Additionally, the study explores different dosages tailored to the child's weight, potentially optimizing treatment effectiveness and safety.

What evidence suggests that dexlansoprazole might be an effective treatment for GERD in children?

Research has shown that dexlansoprazole can reduce GERD symptoms in adults and teens more effectively than lansoprazole. It also benefits those with nonerosive esophageal reflux disease, a condition similar to the one being studied in children. One study found that dexlansoprazole significantly improved nighttime GERD symptoms compared to a placebo. These findings suggest that dexlansoprazole could be effective for children with nonerosive GERD symptoms. In this trial, children will receive different dosages of dexlansoprazole based on their weight to evaluate its effectiveness and safety. ^{6 7 8 9 10}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Dexlansoprazole

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.

How Is the Trial Designed?

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.

Dexlansoprazole is already approved in United States, European Union for the following indications:

Approved in United States as Dexilant for:

• Healing of erosive esophagitis (EE)
• Maintenance of healed EE
• Relief of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD)

Approved in European Union as Dexlansoprazole for:

• Gastroesophageal reflux disease (GERD)
• Erosive esophagitis

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

Published Research Related to This Trial

Dexlansoprazole is a new proton pump inhibitor (PPI) that offers prolonged gastric acid suppression, making it effective for treating symptoms of gastroesophageal reflux disease (GERD) and maintaining healing in erosive esophagitis.

It has been approved by the FDA for once-daily oral use, showing good tolerability and high maintenance rates in patients, particularly those with refractory GERD who may not respond well to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

In a Phase I study involving 36 pediatric patients aged 1 to 11 years with gastroesophageal reflux disease (GERD), dexlansoprazole modified-release (MR) capsules were found to be well tolerated, with most adverse events being mild, such as vomiting and abdominal pain.

The pharmacokinetic analysis revealed that while dexlansoprazole exposure increased with higher doses, it decreased relative to body weight, indicating that dosing may need to be adjusted based on a child's weight to achieve optimal therapeutic levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics and safety of dexlansoprazole MR in pediatric patients with symptomatic gastroesophageal reflux disease. Kukulka, M., Nudurupati, S., Perez, MC.[2022]

Dexlansoprazole modified release (MR) is highly effective in treating erosive esophagitis caused by gastroesophageal reflux disease (GERD), with a unique dual release mechanism that allows for two peak drug concentrations within 2 to 5 hours after administration.

It has the longest maintenance of drug concentration and proton pump inhibitory effect among proton pump inhibitors, a favorable safety profile, and can be taken without regard to meal times, making it a convenient option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexlansoprazole - a new-generation proton pump inhibitor. Skrzydło-Radomańska, B., Radwan, P.[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]

In two large phase III trials, dexlansoprazole MR 60 mg once daily achieved over 92% complete healing in patients with all grades of erosive esophagitis, demonstrating its efficacy compared to lansoprazole.

Dexlansoprazole MR 30 mg once daily was significantly more effective than placebo in maintaining healing of erosive esophagitis and providing heartburn relief in patients with non-erosive reflux disease (NERD), indicating its effectiveness in long-term treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexlansoprazole modified release: in erosive oesophagitis and non-erosive reflux disease. Croxtall, JD., Scott, LJ.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10816097/

The Effect of Dexlansoprazole on Gastroesophageal ... Two studies showed that dexlansoprazole significantly decreased GERD symptoms compared to lansoprazole [33,38]. Peura et al. [33] found ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4634831/

comparative efficacy and outcomes of dexlansoprazole MR Furthermore, dexlansoprazole MR has been found to induce symptom improvement in patients with nonerosive esophageal reflux disease, nocturnal heartburn and GERD ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06778395

Therapeutic Effect of Vonoprazan Versus Dexlansoprazole ... As reported in some studies, the rate of healing of reflux esophagitis was superior to that of a PPI [lansoprazole], with a greater effect seen in cases with ...

4. jnmjournal.org jnmjournal.org/journal/view.html?uid=1141&vmd=Full

A New Proton Pump Inhibitor - Implications for Treatment ... A study to evaluate the effect of dexlansoprazole on nocturnal symptoms in 305 patients found that dexlansoprazole was significantly better than placebo in ...

5. fda.gov fda.gov/media/100629/download

Cross-Discipline Team Leader Review of Dexilant ( ... All of the review disciplines recommend in favor of approval for the indications of healing of EE, maintenance of healed EE and relief of.

6. mayoclinic.org mayoclinic.org/drugs-supplements/dexlansoprazole-oral-route/description/drg-20072564

Dexlansoprazole (oral route) - Side effects & dosage Dexlansoprazole is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat erosive esophagitis or heartburn.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4930293/

Pharmacological and Safety Profile of Dexlansoprazole: A ... In January 2009, the FDA approved dexlansoprazole for the treatment of heartburn associated with symptomatic non-erosive GERD, healing of erosive esophagitis ( ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2012/022287s014lbl.pdf

DEXILANT (dexlansoprazole) Label - accessdata.fda.gov The safety of DEXILANT was evaluated in 4548 ... for 4 weeks to treat heartburn related to gastroesophageal reflux disease (GERD). GERD happens when acid ...

9. webmd.com webmd.com/drugs/2/drug-151809/dexlansoprazole-oral/details

Dexlansoprazole (Dexilant) - Uses, Side Effects, and More Dexlansoprazole is used to treat heartburn and certain other conditions caused by too much acid in the stomach.

10. go.drugbank.com go.drugbank.com/drugs/DB05351

Dexlansoprazole: Uses, Interactions, Mechanism of Action Dexlansoprazole is a proton pump inhibitor used to treat erosive esophagitis, heartburn, and gastroesophageal reflux disease (GERD).