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

Healed Erosive Esophagitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04022096
• Other study ID #: CJ_APA_305
• Status: Completed
• Phase: Phase 3
• Start date: June 18, 2019
• Est. completion date: June 23, 2021

Study information

• Verified date: January 2023
• Source: HK inno.N Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 351
• Est. completion date: June 23, 2021
• Est. primary completion date: June 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophagitis
• Healed Erosive Esophagitis

Intervention

Drug:
• Tegoprazan 25mg QD
Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.
• Lansoprazole 15mg QD
Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Seoul Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endoscopic remission rate of EE at 24-week	Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)	24-week
Secondary	Endoscopic remission rate of EE at 12-week	Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks)	12-week