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

HK inno.N

Status and phase: Completed; Phase 3

Conditions: Healed Erosive Esophagitis

Treatments: Drug: Lansoprazole 15mg QD; Drug: Tegoprazan 25mg QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT04022096

CJ_APA_305

Details and patient eligibility

About

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.

Full 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).

Enrollment: 351 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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351 participants in 2 patient groups

Tegoprazan 25mg QD

Experimental group

Description:

Tegoprazan 25mg tablet, once daily, oral administration

Treatment:

Drug: Tegoprazan 25mg QD

Lansoprazole 15mg QD

Active Comparator group

Description:

Lansoprazole 15mg capsule, once daily, oral administration

Treatment:

Drug: Lansoprazole 15mg QD