Dexlansoprazole for Erosive Esophagitis in Children
Recruiting in Palo Alto (17 mi)
+69 other locations
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Takeda
No Placebo Group
Prior Safety Data
Approved in 2 jurisdictions
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.
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.
13478What 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).
12568Will 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.
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
I am between 2 and 11 years old.
Exclusion Criteria
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.
I do not have any severe health issues other than my current condition that could affect my participation in the study.
I need to take medication that is not allowed in the study.
I have been diagnosed with or show signs of eosinophilic esophagitis.
I have a history of inflammatory or irritable bowel disease.
I have celiac disease confirmed by tests or biopsy.
I have not had active stomach or intestinal ulcers in the last 4 weeks.
I have started my periods before the trial's start.
I am allergic to certain heartburn medications, including dexlansoprazole.
I have or had Zollinger-Ellison syndrome or a similar condition.
I have a history of Barrett's esophagus with abnormal cell changes.
Participant Groups
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.
4Treatment groups
Experimental Treatment
Group I: Maintenance of Healed EE: Dexlansoprazole 30 mgExperimental Treatment1 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 mgExperimental Treatment1 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 mgExperimental Treatment1 Intervention
Dexlansoprazole 60 mg, capsules, orally, once, daily, for 8 weeks.
Group IV: Healing Period: Dexlansoprazole 30 mgExperimental Treatment1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of California San FranciscoSan Francisco, CA
Vanderbilt University Medical CenterNashville, TN
Gastrointestinal Associates, PAFlowood, MS
Measurable Outcome ResearchOklahoma City, OK
More Trial Locations
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Who is running the clinical trial?
TakedaLead Sponsor
References
Dexlansoprazole for the treatment of esophagitis and GERD. [2017]Occasional acid reflux occurs frequently in the general population but gastroesophageal reflux disease (GERD), a chronic disease that affects millions of adults and children, is diagnosed if persistent reflux occurs more than twice a week. The development of proton pump inhibitors (PPIs) dramatically improved the treatment of GERD; however, the treatment of patients with refractory GERD remains a challenge. Dexlansoprazole (TAK-390MR, Kapidex), a pure enantiomer of lansoprazole, is a PPI that, with a novel dual delayed release formulation, provides prolonged inhibition of gastric acid secretion resulting in marked improvements in symptoms of GERD with high maintenance rates and good tolerability. Dexlansoprazole recently received Food and Drug Administration approval for the once-daily oral treatment of heartburn associated with symptomatic nonerosive GERD, the healing of erosive esophagitis (EE) and the maintenance of healed EE.
Esomeprazole for the treatment of erosive esophagitis in children: an international, multicenter, randomized, parallel-group, double-blind (for dose) study. [2021]Acid suppression with a proton pump inhibitor is standard treatment for gastroesophageal reflux disease and erosive esophagitis in adults and increasingly is becoming first-line therapy for children aged 1-17 years. We evaluated endoscopic healing of erosive esophagitis with esomeprazole in young children with gastroesophageal reflux disease and described esophageal histology.
Dexlansoprazole modified release: in erosive oesophagitis and non-erosive reflux disease. [2021]Dexlansoprazole modified release (dexlansoprazole MR) is an orally administered delayed-release formulation of the R-enantiomer of the proton pump inhibitor lansoprazole that is effective in improving the healing of all grades of erosive oesophagitis, maintaining the healing of erosive oesophagitis and in the treatment of symptomatic non-erosive reflux disease (NERD). In two large, identical, 8-week, randomized, double-blind, multicentre phase III trials, dexlansoprazole MR 60 mg once daily achieved complete healing in >or=92% of patients with all grades of erosive oesophagitis (primary endpoint) and was noninferior to lansoprazole 30 mg once daily using life-table analysis. Moreover, in a randomized, double-blind, multicentre phase III trial in patients with healed erosive oesophagitis, dexlansoprazole MR 30 mg once daily was significantly more effective than placebo in maintaining healing following 6 months' treatment (primary endpoint). In addition, the proportion of 24-hour heartburn-free days (primary endpoint) was significantly greater in recipients of dexlansoprazole MR 30 mg once daily than in recipients of placebo following 4 weeks' treatment in a large, randomized, double-blind, multicentre phase III trial in patients with NERD. Dexlansoprazole MR 30 or 60 mg once daily was generally well tolerated in a pooled analysis of clinical trials of up to 12 months' duration.
Dexlansoprazole MR: a review. [2013]Dexlansoprazole MR is the R-enantiomer of lansoprazole that is delivered by a novel system, the dual delayed release formulation. The drug has been shown to be efficacious in healing erosive esophagitis as compared with lansoprazole. When compared to placebo, dexlansoprazole provided significantly higher maintenance rates for healed esophageal mucosa in patients with erosive esophagitis and symptom control in patients with non-erosive reflux disease. Dexlansoprazole could be taken without regard to food. Overall, dexlansoprazole is well tolerated and has a comparable side-effect profile to lansoprazole.
Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study. [2015]Acid suppression with a proton pump inhibitor is standard treatment for gastroesophageal reflux disease and erosive esophagitis in adults and increasingly is becoming first-line therapy for children aged 1-17 years. We evaluated endoscopic healing of erosive esophagitis with esomeprazole in young children with gastroesophageal reflux disease and described esophageal histology.
Esomeprazole for the Treatment of Erosive Esophagitis in Children: An International, Multicenter, Randomized, Parallel-Group, Double-Blind (for Dose) Study. [2015]Acid suppression with a proton pump inhibitor is standard treatment for gastroesophageal reflux disease and erosive esophagitis in adults and increasingly is becoming first-line therapy for children aged 1-17 years. We evaluated endoscopic healing of erosive esophagitis with esomeprazole in young children with gastroesophageal reflux disease and described esophageal histology.
First-week clinical responses to dexlansoprazole 60 mg and esomeprazole 40 mg for the treatment of grades A and B gastroesophageal reflux disease. [2018]To compare the one-week clinical effects of single doses of dexlansoprazole and esomeprazole on grades A and B erosive esophagitis.
Dual Delayed-Release Dexlansoprazole for Healing and Maintenance of Healed Erosive Esophagitis: A Safety Study in Adolescents. [2020]In gastroesophageal reflux disease (GERD), the frequency of heartburn symptoms and erosive esophagitis (EE) increases with age in children and adolescents. Proton pump inhibitor, dexlansoprazole, is approved for healing EE of all grades, maintenance of healed EE, relief of heartburn, and treatment of symptomatic non-erosive GERD in patients ≥ 12 years.