AN EXPLORATORY, MULTICENTER, RANDOMIZED,DOUBLE BLIND STUDY OF CLINICAL OUTCOMES,TOLERABILITY, AND SAFETY OF 2 DOSES OF ORAL PANTOPRAZOLE IN PEDIATRIC PARTICIPANTS AGED 1 TO 11 YEARS AND 12 TO 17 YEARS WHO REQUIRE MAINTENANCE THERAPY FOR HEALED EROSIVE ESOPHAGITIS

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508770-28-00

Acronym

B1791094

Enrollment

Registered

2023-12-20

Start date

2021-10-05

Completion date

2025-11-05

Last updated

2025-05-09

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

Conditions

EROSIVE ESOPHAGITIS

Brief summary

Endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24

Detailed description

Safety and tolerability will be assessed by physical examinations, AE monitoring, clinical laboratory measurements, blood pressure, and pulse rate.

Interventions

DRUGThe placebo for the pantoprazole sodium 40 mg

DRUG20 mg

DRUG10 mg and 5 mg delayed release granules in HPMC capsules

DRUGPANTOPRAZOLE

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24	—

Secondary

Measure	Time frame
Safety and tolerability will be assessed by physical examinations, AE monitoring, clinical laboratory measurements, blood pressure, and pulse rate.	—

Countries

Belgium, Slovakia

Outcome results

None listed

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