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

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)

To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

Study Overview

• Status: Completed
• Conditions: Non-erosive Reflux Disease(NERD)
• Intervention / Treatment: Drug: 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)

• Study Type: Interventional
• Enrollment (Actual): 379
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Dong-A University Hospital
  • Busan, Korea, Republic of
    • Kosin University Gospel Hospital
  • Cheonan, Korea, Republic of
    • Soonchunhyang University Cheonan Hospital
  • Cheongju, Korea, Republic of
    • Chungbuk National University Hospital
  • Chuncheon, Korea, Republic of
    • Hallym University Chuncheon Seonsim Hospital
  • Daegu, Korea, Republic of
    • Keimyung University Dongsan Medical Center
  • Daegu, Korea, Republic of
    • Daegu Catholic Hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Medicar Center
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Goyang, Korea, Republic of
    • Myongji Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Gyeonggi-do, Korea, Republic of
    • Ajou University Hospital
  • Gyeonggi-do, Korea, Republic of
    • Hanyang University Guri Hospital
  • Gyeonggi-do, Korea, Republic of
    • Inje University Ilsan Paik Hospital
  • Gyeonggi-do, Korea, Republic of
    • Soonchunhyang University Bucheon Hospital
  • Iksan, Korea, Republic of
    • Wonkwang University Hospital
  • Ilsan, Korea, Republic of
    • Dongguk University IIsan Hospital
  • Incheon, Korea, Republic of
    • Gachon Gil Hospital
  • Jeju, Korea, Republic of
    • Jeju National University Hospital
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Pusan, Korea, Republic of
    • Pusan National University Hospital
  • Pusan, Korea, Republic of
    • Inje University Busan Paik Hospital
  • Pusan, Korea, Republic of
    • Inje University Haeundae Paik Hospital
  • Pusan, Korea, Republic of
    • Yangsan Pusan National University Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Korea University Guro Hospital
  • Seoul, Korea, Republic of
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Soonchunhyang University Seoul Hospital
  • Seoul, Korea, Republic of
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of
    • Samsung Seoul Hospital
  • Seoul, Korea, Republic of
    • Catholic University Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • Hanyang University Hospital
  • Seoul, Korea, Republic of
    • Konkuk University Hospital
  • Seoul, Korea, Republic of
    • Chung Ang University Hospital
  • Seoul, Korea, Republic of
    • ASAN Medical Center, Seoul
  • Seoul, Korea, Republic of
    • Gangnam Severance
  • Seoul, Korea, Republic of
    • Kyunghee Universtiy Hospital
  • Wŏnju, Korea, Republic of
    • Wonju Severance Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EsoDuo Tab. 20/800mg	Drug: EsoDuo Tab. 20/800mg; Nexium Tab. 20mg
Active Comparator: Nexium Tab. 20mg	Drug: EsoDuo Tab. 20/800mg; Nexium Tab. 20mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks.	Compare Experimental group with Active Comparator.	4 weeks after drug administrations.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Oh Young Lee, M.D., Ph.D., Hanyang University

Publications and helpful links

General Publications

• 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. 2022 Jun 22. doi: 10.5009/gnl220023. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: April 15, 2019
• First Submitted That Met QC Criteria: April 23, 2019
• First Posted (Actual): April 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: 273GERD18019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No