Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis

A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04022096

Enrollment

351

Registered

2019-07-16

Start date

2019-06-18

Completion date

2021-06-23

Last updated

2023-01-27

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

Conditions

Healed Erosive Esophagitis

Brief summary

This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.

Detailed description

This is a double blind, randomized, active-controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 25mg, lansoprazole 15mg).

Interventions

DRUGTegoprazan 25mg QD

Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.

DRUGLansoprazole 15mg QD

Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization 2. Healed erosive esophagitis within 7 days prior to Randomization 3. No heartburn and regurgitation within 7 days prior to Randomization

Exclusion criteria

1. Unable to undergo upper GI endoscopy 2. Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with \>3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy 3. Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD) 4. History of acid-suppressive, esophageal or gastric surgeries

Design outcomes

Primary

Measure	Time frame	Description
Endoscopic remission rate of EE at 24-week	24-week	Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)

Secondary

Measure	Time frame	Description
Endoscopic remission rate of EE at 12-week	12-week	Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026