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Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance

Primary Purpose

Erosive Reflux Disease

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tegoprazan
Esomeprazole
Sponsored by
HK inno.N Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erosive Reflux Disease

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subjects aged between 19 and 75 years
  2. Subjects who have erosive reflux disease

Exclusion Criteria:

  1. Unable to undergo upper GI endoscopy
  2. Symptoms of primary or secondary esophageal movement disorders
  3. Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)

Sites / Locations

  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tegoprazan 50mg

Esomeprazole 40mg

Arm Description

Tegoprazan 50mg tablet, once daily, oral administration

Esomeprazole 40mg tablet, once daily, oral administration

Outcomes

Primary Outcome Measures

Time to first nighttime heartburn-free interval (days))
Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.

Secondary Outcome Measures

Percentage of days without nighttime heartburn during the 2-week dosing period
Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100

Full Information

First Posted
March 13, 2020
Last Updated
February 9, 2022
Sponsor
HK inno.N Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04309916
Brief Title
Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
Official Title
A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 (Pilot) Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 22, 2020 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HK inno.N Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.
Detailed Description
This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tegoprazan 50mg
Arm Type
Experimental
Arm Description
Tegoprazan 50mg tablet, once daily, oral administration
Arm Title
Esomeprazole 40mg
Arm Type
Active Comparator
Arm Description
Esomeprazole 40mg tablet, once daily, oral administration
Intervention Type
Drug
Intervention Name(s)
Tegoprazan
Intervention Description
Tegoprazan 50mg tablet
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Intervention Description
Esomeprazole 40mg tablet
Primary Outcome Measure Information:
Title
Time to first nighttime heartburn-free interval (days))
Description
Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.
Time Frame
2 week
Secondary Outcome Measure Information:
Title
Percentage of days without nighttime heartburn during the 2-week dosing period
Description
Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100
Time Frame
2 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects aged between 19 and 75 years Subjects who have erosive reflux disease Exclusion Criteria: Unable to undergo upper GI endoscopy Symptoms of primary or secondary esophageal movement disorders Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Kil Lee, Ph.D
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance

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