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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

Must not have

Had an acute upper gastrointestinal hemorrhage within 4 weeks prior to endoscopy

Has donated or lost >10% of the total blood volume, undergone plasmapheresis, or has had a transfusion of any blood product within 90 days prior to the first dose of study drug

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 8 to 24

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am between 2 and 11 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I do not have any severe health issues other than my current condition that could affect my participation in the study.

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I need to take medication that is not allowed in the study.

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I have been diagnosed with or show signs of eosinophilic esophagitis.

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I have a history of inflammatory or irritable bowel disease.

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I have celiac disease confirmed by tests or biopsy.

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I have not had active stomach or intestinal ulcers in the last 4 weeks.

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I have started my periods before the trial's start.

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I am allergic to certain heartburn medications, including dexlansoprazole.

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I have or had Zollinger-Ellison syndrome or a similar condition.

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I have a history of Barrett's esophagus with abnormal cell changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 8 to 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 8 to 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 8 to 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants who Maintained Healed EE from Week 8 to Week 24

Percentage of Participants with Healing of EE by Week 8

Secondary study objectives

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 • NCT02351960

Headache

Diarrhoea

100%

80%

60%

40%

20%

Study treatment Arm

Dexlansoprazole 30 mg

Dexlansoprazole 60 mg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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