Dexlansoprazole for Erosive Esophagitis in Children

Recruiting at 69 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

Trial Summary

What is the purpose of this trial?

Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach. The body uses stomach acid to break down food, but when acid rises up into the esophagus it can hurt or damage it. People with GERD often feel food coming back up into the throat and mouth and have a burning feeling in their stomach, chest, or throat, called heartburn. Other symptoms of GERD include pain in the stomach or throat, difficulty eating, and throwing up. Sometimes GERD damages the lining of the esophagus, creating breaks. This is called erosive esophagitis (EE). Dexlansoprazole is a type of medicine that helps lower the amount of acid made in the stomach. It has been shown to heal EE and maintain (keep) healing of EE in adults and teenagers. This study is being done to find out if dexlansoprazole can also heal EE and maintain the healing of EE in children.

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 erosive esophagitis in children?

Dexlansoprazole, a type of proton pump inhibitor (PPI), is approved for healing erosive esophagitis (EE) and maintaining healed EE in patients aged 12 and older. It works by reducing stomach acid, which helps heal the esophagus and relieve heartburn, showing marked improvements in symptoms of gastroesophageal reflux disease (GERD). ^{1 2 3 4 5}

How is the drug dexlansoprazole unique for treating erosive esophagitis in children?

Dexlansoprazole is unique because it uses a dual delayed-release formulation, allowing for prolonged acid suppression, which helps in healing and maintaining healed erosive esophagitis. It can be taken once daily without regard to food, making it convenient for children. ^{1 4 6 7 8}

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

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

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)

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

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

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

Treatment Details

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.

Participant Groups

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

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]

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]

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 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]

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]

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]

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. United States 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. [2015]

3. United States 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. [2015]

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

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

5. England 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. [2021]

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

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

7. England pubmed.ncbi.nlm.nih.gov

Dexlansoprazole MR: a review. [2013]

8. United States 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. [2018]