A Phase 3 interventional study of DW4421 20mg and DW4421 40mg in Erosive Reflux Disease and GERD (Gastroesophageal Reflux Disease), sponsored by Daewon Pharmaceutical Co., Ltd.. Completed at 1 site in South Korea. Open to participants aged 19 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Daewon Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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Among 70 studies in Gastroesophageal Reflux with a site in Korea, Republic of — 8 open to participants now, 10 under way, none of them phase 3. Gastroesophageal Reflux · Korea, Republic of.
Among the 70 studies in Gastroesophageal Reflux with a site in Korea, Republic of, this one is the 5th largest by enrollment of the 52 interventional ones that give a count, is one of 4 that started in 2025, is one of 11 in phase 3, and was the 69th registered.
1,213 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
Browse Gastroesophageal Reflux studies →8 of the 70 studies in Gastroesophageal Reflux with a site in Korea, Republic of are open now. Recruiting first, the newest first:
HK inno.N Corporation · Sites in Korea, Republic of
Ages 19+
Incheon St.Mary's Hospital · Sites in Korea, Republic of
Ages 19+
Jeil Pharmaceutical Co., Ltd. · Sites in Korea, Republic of
Ages 19+
HK inno.N Corporation · Sites in Korea, Republic of
Ages 19–75
HK inno.N Corporation · Sites in Korea, Republic of
Ages 19+
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 132 Gastroesophageal Reflux studies recruiting now, 56 (42%) set no upper age limit and 53 (40%) stop at 75 or younger; 22 take children under 18; 20 take healthy volunteers.
This study: 19 Years to 74 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
70 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 22 · Phase 2 6 · Phase 3 11 · Phase 4 8
First in 2006; this study’s year is marked. 4 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 328 is above the median of 68 across 798 interventional studies indexed under Gastroesophageal Reflux.
Median enrollment 54 across the 52 interventional studies, 1,775 across the 18 observational. Of the 50 that completed or were terminated, 2 (4%) have results posted.
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44 of 70 have an industry lead sponsor. The 10 most frequent:
Daewon Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 7 are open to participants now.
Daewon Pharmaceutical Co., Ltd. has 2 studies filed under Gastroesophageal Reflux — fewer than ten, so there is no comparison to draw.
1 of the studies in Gastroesophageal Reflux with a site in Korea, Republic of that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07678177HK inno.N CorporationAn Observational Study to Evaluate the Efficacy and Safety of K-CAB Tab./K-CAB ODT(Tegoprazan) in GERD Patients | 2027-06-30 |
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Among the 70 studies in Gastroesophageal Reflux with a site in Korea, Republic of, from their registry updates:
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This study aims to compare the efficacy and safety of DW4421 to Esomeprazole in patients with Erosive Reflux Disease.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
[Medical history]
[Concomitant medication use]
[Laboratory criteria]
- abnormal laboratory values during screening.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: DW4421 20mg
Drug: DW4421 40mg
Drug: Esomeprazole 40mg
DW4421 20mg 1Tab. + DW4421 40mg placebo 1Tab. + Esomeprazole 40mg placebo 1Tab., once daily, PO
DW4421 20mg placebo 1Tab. + DW4421 40mg 1Tab. + Esomeprazole 40mg placebo 1Tab., once daily, PO
DW4421 20mg placebo 1Tab. + DW4421 40mg placebo 1Tab. + Esomeprazole 40mg placebo 1Tab., once daily, PO
Cumulative healing rate of mucosal break evaluated by BICR (Blind Independent Central Review) at Week 8 after administration of the investigational product (%)
Time frame: Week 8
Cumulative healing rate of mucosal break evaluated by BICR at Week 4 after administration of the investigational product (%)
Time frame: Week 4
Change from baseline in frequency and severity of primary symptoms evaluated in the RDQ (Reflux Disease Questionnaire) respectively at Weeks 4 and 8 after administration of the investigational product
Time frame: Weeks 4 and 8
Change from baseline in total score of GERD-HRQL (GERD-Health Related Quality Life) at Weeks 4 and 8 after administration of the investigational product
Time frame: Weeks 4 and 8
Proportion of subjects without primary RDQ symptoms within 24 hours after the first dose (%)
Time frame: Within 24 hours
Time to first complete resolution of primary RDQ symptoms through Day 7 after the first dose, and the proportion of subjects (%)
Time frame: Day 7
Proportion of primary RDQ symptom-free days through Day 7 after the first dose (%): Daytime, Nighttime, 24-hour
Time frame: Day 7
Proportion of subjects without primary and secondary RDQ symptoms at Day 7 after the first dose (%)
Time frame: Day 7
Proportion of primary RDQ symptom-free patients at Weeks 4 and 8 after the first dose (%)
Time frame: Weeks 4 and 8
Proportion of primary RDQ symptom-free days at Weeks 4 and 8 after the first dose (%): Daytime, Nighttime, 24-hour
Time frame: Weeks 4 and 8
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2025 to primary completion in Aug 2026, 9 months.
Of 21 phase 3 interventional studies under Gastroesophageal Reflux, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 49. This study's 9 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Daewon Pharmaceutical Co., Ltd. →