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Proton Pump Inhibitor
Dexlansoprazole for Erosive Esophagitis in Children
Phase 2
Recruiting
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is male or female and age 2 to 11 years, inclusive, at the time of screening informed consent
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 8 to 24
Awards & highlights
Study Summary
This trial will study the side effects and effectiveness of Dexlansoprazole in healing erosive esophagitis and maintaining healed EE in children.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects likely include digestive issues such as stomach pain, diarrhea, nausea; headache; or allergic reactions since these are common with similar medications like proton pump inhibitors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 2 and 11 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 8 to 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 8 to 24
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Participants who Maintained Healed EE from Week 8 to Week 24
Percentage of Participants with Healing of Erosive Esophagitis (EE) by Week 8
Secondary outcome measures
Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over Weeks 8 to 24 Among Participants Who were Healed by Week 8
Percentage of Days Without Hurting or Burning in the Stomach, Chest or Throat Over the First 8 Weeks of Treatment
Side effects data
From 2016 Phase 4 trial • 296 Patients • NCT023519602%
Headache
1%
Diarrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dexlansoprazole 30 mg
Dexlansoprazole 60 mg
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexlansoprazole
2010
Completed Phase 4
~1290
Find a Location
Who is running the clinical trial?
TakedaLead Sponsor
1,203 Previous Clinical Trials
4,177,949 Total Patients Enrolled
10 Trials studying Erosive Esophagitis
2,840 Patients Enrolled for Erosive Esophagitis
Medical Director Clinical ScienceStudy DirectorTakeda
197 Previous Clinical Trials
63,171 Total Patients Enrolled
2 Trials studying Erosive Esophagitis
489 Patients Enrolled for Erosive Esophagitis
Study DirectorStudy DirectorTakeda
1,211 Previous Clinical Trials
489,277 Total Patients Enrolled
1 Trials studying Erosive Esophagitis
208 Patients Enrolled for Erosive Esophagitis
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 have a condition or history of treatment that has affected my esophagus.I have had symptoms of acid reflux for at least 3 months.My recent endoscopy shows I have esophagitis from Grade A to D.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 have had surgery on my stomach, duodenum, or esophagus, but not just for an ulcer.I (or my guardian) understand and can follow the study's requirements.I tried stopping my acid reflux medicine before, but my symptoms came back.I am between 2 and 11 years old.I need a procedure to widen my esophagus to allow for an endoscopy.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.I don't have any health issues that could affect the trial.I might need surgery that requires a hospital stay during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Healing Period: Dexlansoprazole 30 mg
- Group 2: Maintenance of Healed EE: Dexlansoprazole 30 mg
- Group 3: Maintenance of Healed EE: Dexlansoprazole 15 mg
- Group 4: Healing Period: Dexlansoprazole 60 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are volunteering for this research project?
"This specific study has stopped recruiting patients, as evidenced by the fact that the clinical trial was originally posted on 1/13/2023 and was most recently edited on 9/16/2022. However, there are currently 43 other clinical trials for erosive esophagitis and 4 studies for Dexlansoprazole that are actively recruiting patients."
Answered by AI
How is Dexlansoprazole most commonly employed?
"Dexlansoprazole is an effective medication for healing patients with erosive esophagitis, heartburn, and other esophageal conditions."
Answered by AI
Could you compare and contrast Dexlansoprazole's efficacy to other drugs?
"There are 4 active clinical trials and 0 in Phase 3 for the use of Dexlansoprazole. Out of the 48 total locations, many of the studies are taking place in Bucheon, Gyeonggi-do."
Answered by AI
Is there an age limit for eligibility for this trial?
"In order for children to be eligible for this clinical trial, they must be aged between 2 and 11 years old."
Answered by AI
Has Dexlansoprazole undergone FDA approval process?
"There is some data supporting the safety of Dexlansoprazole, but none indicating that it is an effective medication. Consequently, it received a score of 2."
Answered by AI
Is this clinical trial common in Canadian hospitals?
"There are 17 total sites across the United States enrolling patients for this study. Three of these sites are University of Louisville in Louisville, Kentucky, Willis-Knighton Physician Network in Shreveport, Louisiana, and University of Chicago in Chicago, Illinois."
Answered by AI
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