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

December 23, 2019 updated by: Chong Kun Dang Pharmaceutical

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
379

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks.
Time Frame: 4 weeks after drug administrations.
Compare Experimental group with Active Comparator.
4 weeks after drug administrations.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks.
Time Frame: 2 weeks after drug administrations
Compare Experimental group with Active Comparator.
2 weeks after drug administrations
Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks.
Time Frame: 2/4 weeks after drug administrations.
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.
Time Frame: 2/4 weeks after drug administrations.
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.
Time Frame: 2/4 weeks after drug administrations.
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.
Time Frame: 2/4 weeks after drug administrations.
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.
Time Frame: 2/4 weeks after drug administrations.
Compare Experimental group with Active Comparator.
2/4 weeks after drug administrations.
Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks.
Time Frame: 4 weeks after drug administrations.
Compare Experimental group with Active Comparator.
4 weeks after drug administrations.
Time to first resolution of Heartburn(HB), Day 1
Time Frame: 1 day after drug administrations.
Compare Experimental group with Active Comparator.
1 day after drug administrations.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chong Kun Dang Pharmaceutical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Oh Young Lee, M.D., Ph.D., Hanyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 29, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 15, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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