Dexlansoprazole for Erosive Esophagitis in Children

Recruiting at 76 trial locations

Overseen By Takeda Contact

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Must not be taking: PPIs, Antacids

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: Unknown

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether dexlansoprazole (also known as Dexilant or Kapidex) can heal and maintain healing of erosive esophagitis (EE) in children. EE occurs when stomach acid damages the esophagus, often due to gastroesophageal reflux disease (GERD). Dexlansoprazole reduces stomach acid and has proven effective in adults and teens. This study aims to determine its effectiveness in children. Children who have experienced GERD symptoms, such as heartburn or pain in the stomach or throat for at least three months, and have been diagnosed with EE may be suitable for this trial. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 this trial's treatment is likely to be safe for children?

Research has shown that dexlansoprazole is generally safe for use. The FDA has approved it to treat erosive esophagitis (EE) in adults and teenagers. Studies have found that it can help heal the esophagus by lowering stomach acid levels.

Some people have reported mild side effects such as diarrhea, stomach pain, or nausea. These are common with many medications and are usually not serious. The studies reviewed have not reported significant severe side effects.

Overall, existing research suggests that dexlansoprazole is safe for the approved age groups. This trial specifically examines its safety in children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for GERD?

Most treatments for erosive esophagitis in children, like proton pump inhibitors (PPIs) such as omeprazole and lansoprazole, work by reducing stomach acid production to allow healing of the esophagus. Dexlansoprazole stands out because it offers a dual delayed-release mechanism, which can provide extended acid suppression throughout the day with just one daily dose. This unique feature could enhance healing and maintenance by ensuring consistent relief from symptoms and better healing of the esophagus. Researchers are particularly excited because this could mean improved adherence to treatment and potentially faster healing times compared to current options.

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

Research has shown that dexlansoprazole effectively heals and maintains the healing of erosive esophagitis (EE). In adults and teenagers, studies have found that 30 mg and 60 mg doses of dexlansoprazole help heal the esophagus and maintain its healing over time. This trial will evaluate the effectiveness of dexlansoprazole in children, with participants receiving either 30 mg or 60 mg doses during the healing period. This treatment outperforms a placebo in maintaining EE healing. Additionally, dexlansoprazole has reduced GERD symptoms more effectively than other treatments like lansoprazole. These findings suggest that dexlansoprazole could also benefit children with similar conditions. ^{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 2-11 with a history of GERD symptoms for at least 3 months and evidence of erosive esophagitis (EE). They must have had symptoms return after stopping previous acid-suppressive therapy. Children who've used certain drugs, have specific gastrointestinal conditions, or are unlikely to follow the study plan cannot participate.

Inclusion Criteria

Prior to any study-specific procedures being performed, the appropriate screening informed consent and the assent forms (as applicable) must be signed and dated by parent(s) or legal guardian and by the participant respectively, if appropriate

Has met the eDiary qualification criteria as assessed by the PGSDD, defined as hurting or burning in the stomach, chest, or throat on at least 3 of any 7 consecutive days during the Screening Period. (Note: If an endoscopy performed within 1 week of signing screening informed consent and assent [as applicable] is used to confirm diagnosis of EE, the participant does not need to meet this criterion)

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

Exclusion Criteria

Tests positive for H. pylori

I had severe bleeding in my stomach or upper intestines within the last month.

I haven't donated blood, had a transfusion, or lost a lot of blood in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Healing of EE Period

Participants receive dexlansoprazole 60 mg or 30 mg daily for 8 weeks to heal erosive esophagitis

8 weeks

Weekly visits for monitoring

Maintenance of Healed EE Period

Participants receive half their healing dose of dexlansoprazole for 16 weeks to maintain healing

16 weeks

Monthly visits for monitoring

Post-Treatment Follow-up

Participants are monitored for safety and effectiveness after treatment, completing symptom questionnaires daily

3 months

Monthly clinic visits

What Are the Treatments Tested in This Trial?

Interventions

• Dexlansoprazole

Trial Overview The trial tests Dexlansoprazole's safety and effectiveness in healing EE and maintaining its healing in children. Participants will take this medication orally to see how well it works and what side effects may occur during treatment.

How Is the Trial Designed?

Group I: Maintenance of Healed EE: Dexlansoprazole 30 mg Experimental Treatment 1 Intervention

Participants on Dexlansoprazole 60 mg treatment arm in Healing Period will receive half dose, dexlansoprazole 30 mg, capsules, orally, once, daily, for 16 weeks in the Maintenance Period.

Group II: Maintenance of Healed EE: Dexlansoprazole 15 mg Experimental Treatment 1 Intervention

Participants on Dexlansoprazole 30 mg treatment arm in Healing Period will receive half dose, dexlansoprazole 15 mg, capsules, orally, once, daily, for 16 weeks in the Maintenance Period.

Group III: Healing Period: Dexlansoprazole 60 mg Experimental Treatment 1 Intervention

Dexlansoprazole 60 mg, capsules, orally, once, daily, for 8 weeks.

Group IV: Healing Period: Dexlansoprazole 30 mg Experimental Treatment 1 Intervention

Dexlansoprazole 30 mg, capsules, orally, once, daily, for 8 weeks.

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

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 study of 109 children aged 1-11 years with gastroesophageal reflux disease, esomeprazole treatment led to an impressive 89% resolution of erosive esophagitis after 8 weeks, demonstrating its efficacy in healing this condition.

Histological examination revealed that 24% of patients showed dilation of intercellular space, suggesting it could be a significant marker for erosive esophagitis in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study. Tolia, V., Youssef, NN., Gilger, MA., et al.[2015]

In a study of 109 children aged 1-11 years with gastroesophageal reflux disease, esomeprazole treatment led to an impressive 89% resolution of erosive esophagitis after 8 weeks, demonstrating its efficacy in healing this condition.

Histological examination revealed that 24% of patients showed dilation of intercellular space, suggesting it could be a significant marker for erosive esophagitis in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study. Tolia, V., Youssef, NN., Gilger, MA., et al.[2015]

In a study of 109 children aged 1-11 years with gastroesophageal reflux disease, esomeprazole treatment led to an impressive 89% resolution of erosive esophagitis after 8 weeks, demonstrating its efficacy in healing this condition.

Histological examination revealed that 24% of patients showed dilation of intercellular space, suggesting it may serve as an important marker for erosive esophagitis in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study. Tolia, V., Youssef, NN., Gilger, MA., et al.[2021]

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]

Dexlansoprazole MR is more effective than lansoprazole in healing erosive esophagitis and provides better maintenance of healed esophageal mucosa compared to placebo.

The drug can be taken without regard to food and is well tolerated, showing a side-effect profile similar to that of lansoprazole.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexlansoprazole MR: a review. Hershcovici, T., Jha, LK., Fass, R.[2013]

In a study of 175 adult patients with gastroesophageal reflux disease (GERD), both dexlansoprazole and esomeprazole showed similar rates of complete symptom resolution (CSR) over one week, indicating comparable efficacy for treating grades A and B erosive esophagitis.

However, female patients taking dexlansoprazole experienced significantly higher CSR rates at day 3 compared to those taking esomeprazole (38.3% vs 18.4%), suggesting that dexlansoprazole may be more effective for women in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-week clinical responses to dexlansoprazole 60 mg and esomeprazole 40 mg for the treatment of grades A and B gastroesophageal reflux disease. Liang, CM., Kuo, MT., Hsu, PI., et al.[2018]

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/PMC4634831/

comparative efficacy and outcomes of dexlansoprazole MR Dexlansoprazole MR was significantly more effective in maintaining healed erosive esophagitis than placebo. ... erosive esophagitis outcomes.27. Conclusion ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6514063/

Dual Delayed-Release Dexlansoprazole for Healing and ... After EE healing, dexlansoprazole has also shown efficacy at 30- and 60-mg once-daily doses in maintaining healed EE for up to 6 months and in ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00251719?term=lansoprazole&viewType=Table&rank=4

Efficacy and Safety of Dexlansoprazole MR ... Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...

4. fda.gov fda.gov/media/100082/download

Statistical Review and Evaluation: Dexilant The statistical reviewer confirmed the sponsor's analysis results for all of the aforementioned four efficacy endpoints. For the first efficacy ...

5. mdpi.com mdpi.com/1422-0067/25/2/1247

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 significant results, ...

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

DEXILANT (dexlansoprazole) Label - accessdata.fda.gov 1.1 Healing of Erosive Esophagitis DEXILANT is indicated for healing of all grades of erosive esophagitis (EE) for up to 8 weeks. 1.2 Maintenance of Healed ...

7. 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.

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

Dexlansoprazole (Dexilant) - Uses, Side Effects, and More Find patient medical information for Dexlansoprazole (Dexilant) on WebMD including its uses, side effects and safety, interactions, pictures,

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

Pharmacological and Safety Profile of Dexlansoprazole: A ... Dexlansoprazole has been shown to be effective for healing of erosive esophagitis, and to improve subjective well-being by controlling 24-hour symptoms.

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

Dexlansoprazole: Uses, Interactions, Mechanism of Action Dexlansoprazole is a proton pump inhibitor (PPI) indicated for the: Healing of all grades of erosive esophagitis (EE) for up to eight weeks in patients 12 years ...