A Phase 2, Double-Blind, 36-Week, Multicenter Study to Assess the Safety and Effectiveness of Daily Oral Administration of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis (EE) and Maintenance of Healed EE in Pediatric Subjects Aged 2 to 11 Years With EE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501350-11-00

Acronym

TAK-390MR_205

Enrollment

Registered

2024-04-05

Start date

2023-02-01

Completion date

Unknown

Last updated

2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive Esophagitis

Brief summary

Percentage of subjects with healing of EE by Week 8 as assessed by endoscopy., Percentage of subjects who maintained healed EE for 16 weeks among the subjects who were healed by Week 8 as assessed by endoscopy.

Detailed description

Percentage of days without hurting or burning in the stomach, chest or throat over the first 8 weeks of treatment, Percentage of days without hurting or burning in the stomach, chest or throat over Weeks 8 to 24 or Weeks 12 to 28 among subjects who were healed by Week 8

Interventions

DRUGDEXLANSOPRAZOLE PEDIATRIC

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Percentage of subjects with healing of EE by Week 8 as assessed by endoscopy., Percentage of subjects who maintained healed EE for 16 weeks among the subjects who were healed by Week 8 as assessed by endoscopy.	—

Secondary

Measure	Time frame
Percentage of days without hurting or burning in the stomach, chest or throat over the first 8 weeks of treatment, Percentage of days without hurting or burning in the stomach, chest or throat over Weeks 8 to 24 or Weeks 12 to 28 among subjects who were healed by Week 8	—

Countries

Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026