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

Sponsor

HK inno.N Corporation (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04022096

Collaborator

(none)

318

Enrollment

Location

Arms

18.5

Anticipated Duration (Months)

17.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healed Erosive Esophagitis	Drug: Tegoprazan 25mg QD Drug: Lansoprazole 15mg QD	Phase 3

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

318 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 18, 2019

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tegoprazan 25mg QD Tegoprazan 25mg tablet, once daily, oral administration	Drug: Tegoprazan 25mg QD Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.
Active Comparator: Lansoprazole 15mg QD Lansoprazole 15mg capsule, once daily, oral administration	Drug: Lansoprazole 15mg QD Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.

Arm

Intervention/Treatment

Experimental: Tegoprazan 25mg QD

Tegoprazan 25mg tablet, once daily, oral administration

Drug: Tegoprazan 25mg QD

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

Active Comparator: Lansoprazole 15mg QD

Lansoprazole 15mg capsule, once daily, oral administration

Drug: Lansoprazole 15mg QD

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Unable to undergo upper GI endoscopy
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
Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
History of acid-suppressive, esophageal or gastric surgeries

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hanyang University Seoul Hospital	Seoul		Korea, Republic of	133-792

Sponsors and Collaborators

HK inno.N Corporation

Investigators

Principal Investigator: Oh Young Lee, Ph.D, Hanyang University Seoul Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

HK inno.N Corporation

ClinicalTrials.gov Identifier:

NCT04022096

Other Study ID Numbers:

CJ_APA_305

First Posted:

Jul 16, 2019

Last Update Posted:

Jul 16, 2019

Last Verified:

Jul 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Esophagitis

Lansoprazole

Dexlansoprazole

Study Results

No Results Posted as of Jul 16, 2019