We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04022096
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04022096
Recruitment Status : Completed
First Posted : July 16, 2019
Last Update Posted : January 27, 2023
Sponsor:
Information provided by (Responsible Party):
HK inno.N Corporation

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 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 : June 18, 2019
Actual Primary Completion Date : June 23, 2021
Actual Study Completion Date : June 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Endoscopic remission rate of EE at 24-week [ Time Frame: 24-week ]
    Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)


Secondary Outcome Measures :
  1. Endoscopic remission rate of EE at 12-week [ Time Frame: 12-week ]
    Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022096


Locations
Layout table for location information
Korea, Republic of
Hanyang University Seoul Hospital
Seoul, Korea, Republic of, 133-792
Sponsors and Collaborators
HK inno.N Corporation
Investigators
Layout table for investigator information
Principal Investigator: Oh Young Lee, Ph.D Hanyang University Seoul Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: HK inno.N Corporation
ClinicalTrials.gov Identifier: NCT04022096    
Other Study ID Numbers: CJ_APA_305
First Posted: July 16, 2019    Key Record Dates
Last Update Posted: January 27, 2023
Last Verified: January 2023

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Lansoprazole
 Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action