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Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

Primary Purpose

Non-erosive Reflux Disease(NERD)

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
EsoDuo Tab. 20/800mg
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-erosive Reflux Disease(NERD)

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or Female aged ≥ 19 years
  2. Episode of heartburn for 3 months or more during prior to randomization visit.
  3. Episode of heartburn for 2 days or more during the last 7 days prior to randomization visit.
  4. Grade N, M by EGD test.

Exclusion Criteria:

  1. Surgery history on stomach or esophagus
  2. Active medical history of stomach, esophagus area
  3. Other system disorder which can disturb this trial
  4. Patients taking the contraindication of concomitant medications
  5. Clinically significant Abnormal Lab test
  6. Pregnant woman, Breastfeeding woman.

Sites / Locations

  • Dong-A University Hospital
  • Kosin University Gospel Hospital
  • Soonchunhyang University Cheonan Hospital
  • Chungbuk National University Hospital
  • Hallym University Chuncheon Seonsim Hospital
  • Daegu Catholic Hospital
  • Keimyung University Dongsan Medical Center
  • Yeungnam University Medicar Center
  • Chungnam National University Hospital
  • Myongji Hospital
  • Chonnam National University Hospital
  • Ajou University Hospital
  • Hanyang University Guri Hospital
  • Inje University ilsan Paik Hospital
  • Soonchunhyang University Bucheon Hospital
  • Wonkwang University Hospital
  • Dongguk University IIsan Hospital
  • Gachon Gil Hospital
  • Jeju National University Hospital
  • Chonbuk National University Hospital
  • Inje University Busan Paik Hospital
  • Inje University Haeundae Paik Hospital
  • Pusan National University Hospital
  • Yangsan Pusan National University Hospital
  • Asan Medical Center, Seoul
  • Catholic University Seoul St. Mary's Hospital
  • Chung Ang University Hospital
  • Gangnam Severance
  • Hanyang University Hospital
  • Konkuk University Hospital
  • Korea University Anam Hospital
  • Korea University Guro Hospital
  • Kyunghee Universtiy Hospital
  • Samsung Seoul Hospital
  • Seoul National University Hospital
  • Severance Hospital
  • Soonchunhyang University Seoul Hospital
  • Wonju Severance Christian Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EsoDuo Tab. 20/800mg

Nexium Tab. 20mg

Arm Description

EsoDuo Tab. 20/800mg

Nexium Tab. 20mg

Outcomes

Primary Outcome Measures

Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks.
Compare Experimental group with Active Comparator.

Secondary Outcome Measures

Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks.
Compare Experimental group with Active Comparator.
Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks.
Compare Experimental group with Active Comparator.
The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks.
Compare Experimental group with Active Comparator.
The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks.
Compare Experimental group with Active Comparator.
The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval.
Compare Experimental group with Active Comparator.
Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks.
Compare Experimental group with Active Comparator.
Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks.
Compare Experimental group with Active Comparator.
Time to first resolution of Heartburn(HB), Day 1
Compare Experimental group with Active Comparator.

Full Information

First Posted
April 15, 2019
Last Updated
December 23, 2019
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT03928470
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg
Official Title
A Multicenter, Randomized, Double-blind, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg in Patients With Non-erosive Reflux Disease(NERD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

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
To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg
Detailed Description
A multicenter, randomized, double-blind, active-controlled phase 4 study to evaluate the efficacy and safety of EsoDuo Tab. 20/800mg in patients with non-erosive reflux disease(NERD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-erosive Reflux Disease(NERD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
379 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EsoDuo Tab. 20/800mg
Arm Type
Experimental
Arm Description
EsoDuo Tab. 20/800mg
Arm Title
Nexium Tab. 20mg
Arm Type
Active Comparator
Arm Description
Nexium Tab. 20mg
Intervention Type
Drug
Intervention Name(s)
EsoDuo Tab. 20/800mg
Intervention Description
Nexium Tab. 20mg
Primary Outcome Measure Information:
Title
Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks.
Description
Compare Experimental group with Active Comparator.
Time Frame
4 weeks after drug administrations.
Secondary Outcome Measure Information:
Title
Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks.
Description
Compare Experimental group with Active Comparator.
Time Frame
2 weeks after drug administrations
Title
Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks.
Description
Compare Experimental group with Active Comparator.
Time Frame
2/4 weeks after drug administrations.
Title
The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks.
Description
Compare Experimental group with Active Comparator.
Time Frame
2/4 weeks after drug administrations.
Title
The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks.
Description
Compare Experimental group with Active Comparator.
Time Frame
2/4 weeks after drug administrations.
Title
The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval.
Description
Compare Experimental group with Active Comparator.
Time Frame
2/4 weeks after drug administrations.
Title
Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks.
Description
Compare Experimental group with Active Comparator.
Time Frame
2/4 weeks after drug administrations.
Title
Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks.
Description
Compare Experimental group with Active Comparator.
Time Frame
4 weeks after drug administrations.
Title
Time to first resolution of Heartburn(HB), Day 1
Description
Compare Experimental group with Active Comparator.
Time Frame
1 day after drug administrations.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or Female aged ≥ 19 years Episode of heartburn for 3 months or more during prior to randomization visit. Episode of heartburn for 2 days or more during the last 7 days prior to randomization visit. Grade N, M by EGD test. Exclusion Criteria: Surgery history on stomach or esophagus Active medical history of stomach, esophagus area Other system disorder which can disturb this trial Patients taking the contraindication of concomitant medications Clinically significant Abnormal Lab test Pregnant woman, Breastfeeding woman.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oh Young Lee, M.D., Ph.D.
Organizational Affiliation
Hanyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Kosin University Gospel Hospital
City
Busan
Country
Korea, Republic of
Facility Name
Soonchunhyang University Cheonan Hospital
City
Cheonan
Country
Korea, Republic of
Facility Name
Chungbuk National University Hospital
City
Cheongju
Country
Korea, Republic of
Facility Name
Hallym University Chuncheon Seonsim Hospital
City
Chuncheon
Country
Korea, Republic of
Facility Name
Daegu Catholic Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
Country
Korea, Republic of
Facility Name
Yeungnam University Medicar Center
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National University Hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Myongji Hospital
City
Goyang
Country
Korea, Republic of
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Hanyang University Guri Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Inje University ilsan Paik Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Soonchunhyang University Bucheon Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Wonkwang University Hospital
City
Iksan
Country
Korea, Republic of
Facility Name
Dongguk University IIsan Hospital
City
Ilsan
Country
Korea, Republic of
Facility Name
Gachon Gil Hospital
City
Incheon
Country
Korea, Republic of
Facility Name
Jeju National University Hospital
City
Jeju
Country
Korea, Republic of
Facility Name
Chonbuk National University Hospital
City
Jeonju
Country
Korea, Republic of
Facility Name
Inje University Busan Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Inje University Haeundae Paik Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Yangsan Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Facility Name
Asan Medical Center, Seoul
City
Seoul
Country
Korea, Republic of
Facility Name
Catholic University Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Chung Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance
City
Seoul
Country
Korea, Republic of
Facility Name
Hanyang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Konkuk University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Kyunghee Universtiy Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Seoul Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Soonchunhyang University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Wonju Severance Christian Hospital
City
Wŏnju
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35730245
Citation
Park SH, Lee KN, Lee OY, Choi MG, Kim JH, Sung IK, Jang JY, Park KS, Chun HJ, Kim EY, Lee JK, Jang JS, Kim GH, Hong SJ, Lee YC, Choi SC, Kim HS, Kim TO, Baik GH, Jeon YC. A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease. Gut Liver. 2023 Mar 15;17(2):226-233. doi: 10.5009/gnl220023. Epub 2022 Jun 22.
Results Reference
derived

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Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

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