Non-erosive Reflux Disease(NERD)Phase 4NCT03928470
Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg
A Phase 4 study testing EsoDuo Tab. 20/800mg in people with Non-erosive Reflux Disease(NERD), run by Chong Kun Dang Pharmaceutical at 38 sites in South Korea.
Trial summary
To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Non-erosive Reflux Disease(NERD)
- What is being tested?
- EsoDuo Tab. 20/800mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 379 participants
- Where
- 38 sitesSouth Korea
- Study dates
- 29 Jan 2019to 20 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
South Korea38 sites
Dong-A University Hospital
Busan
Kosin University Gospel Hospital
Busan
Soonchunhyang University Cheonan Hospital
Cheonan
Chungbuk National University Hospital
Cheongju-si
Hallym University Chuncheon Seonsim Hospital
Chuncheon
Daegu Catholic Hospital
Daegu
Keimyung University Dongsan Medical Center
Daegu
Yeungnam University Medicar Center
Daegu
Chungnam National University Hospital
Daejeon
Myongji Hospital
Goyang
Chonnam National University Hospital
Gwangju
Ajou University Hospital
Gyeonggi-do
Hanyang University Guri Hospital
Gyeonggi-do
Inje University ilsan Paik Hospital
Gyeonggi-do
Soonchunhyang University Bucheon Hospital
Gyeonggi-do
Wonkwang University Hospital
Iksan
Dongguk University IIsan Hospital
Ilsan
Gachon Gil Hospital
Incheon
Jeju National University Hospital
Jeju City
Chonbuk National University Hospital
Jeonju
Inje University Busan Paik Hospital
Pusan
Inje University Haeundae Paik Hospital
Pusan
Pusan National University Hospital
Pusan
Yangsan Pusan National University Hospital
Pusan
Asan Medical Center, Seoul
Seoul
Catholic University Seoul St. Mary's Hospital
Seoul
Chung Ang University Hospital
Seoul
Gangnam Severance
Seoul
Hanyang University Hospital
Seoul
Konkuk University Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Kyunghee Universtiy Hospital
Seoul
Samsung Seoul Hospital
Seoul
Seoul National University Hospital
Seoul
Severance Hospital
Seoul
Soonchunhyang University Seoul Hospital
Seoul
Wonju Severance Christian Hospital
Wŏnju
About this study
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)
To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg
Read the 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)
- Conditions
- Non-erosive Reflux Disease(NERD)
- Being tested
- EsoDuo Tab. 20/800mg
- Medical subject headings
- Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsoDuo Tab. 20/800mgDrug
Nexium Tab. 20mg
| Study group | Role | What they receive |
|---|---|---|
| EsoDuo Tab. 20/800mg | Experimental | EsoDuo Tab. 20/800mg Receives: Drug: EsoDuo Tab. 20/800mg |
| Nexium Tab. 20mg | Active comparator | Nexium Tab. 20mg Receives: Drug: EsoDuo Tab. 20/800mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks.
Compare Experimental group with Active Comparator.
Measured: 4 weeks after drug administrations.
Secondary outcomes (8)
Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks.
Compare Experimental group with Active Comparator.
Measured: 2 weeks after drug administrations
Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks.
Compare Experimental group with Active Comparator.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2/4 weeks after drug administrations.
Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks.
Compare Experimental group with Active Comparator.
Measured: 4 weeks after drug administrations.
Time to first resolution of Heartburn(HB), Day 1
Compare Experimental group with Active Comparator.
Measured: 1 day after drug administrations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start29 Jan 2019
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-erosive Reflux Disease(NERD)Studies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 379 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oh Young Lee, M.D., Ph.D., Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928470
- Sponsor's protocol ID
- 273GERD18019
- Status last verified
- Dec 2019
- First submitted
- 15 Apr 2019
- Last updated
- 24 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 2023 Mar 15;17(2):226-233. doi: 10.5009/gnl220023. Epub 2022 Jun 22.
PubMed 35730245
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03928470
- Acronym / sponsor ID
- 273GERD18019
- Conditions
- Non-erosive Reflux Disease(NERD)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 379 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 26 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EsoDuo Tab. 20/800mg | Experimental | Drug: EsoDuo Tab. 20/800mgEsoDuo Tab. 20/800mg |
| Nexium Tab. 20mg | Active comparator | Drug: EsoDuo Tab. 20/800mgNexium Tab. 20mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsoDuo Tab. 20/800mgNexium Tab. 20mg | Drug | EsoDuo Tab. 20/800mg, Nexium Tab. 20mg |
Primary outcome
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.
8 secondary outcomes
Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks.
Time frame: 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.
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.
The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks.
Time frame: 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.
Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks.
Time frame: 2/4 weeks after drug administrations.
Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks.
Time frame: 4 weeks after drug administrations.
Time to first resolution of Heartburn(HB), Day 1
Time frame: 1 day after drug administrations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2019.
- Derived from this study: PubMed 35730245Park 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oh Young Lee, M.D., Ph.D. principal investigator
Hanyang University
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EsoDuo Tab. 20/800mg in people with Non-erosive Reflux Disease(NERD), run by Chong Kun Dang Pharmaceutical at 38 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks. (time frame: 4 weeks after drug administrations.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03928470, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2019.