Clinical Trial to Evaluate the Safety and Efficacy of DW4421 in Patients With Erosive Reflux Disease
NCT07931521, Phase 3, Completed, Daewon Pharmaceutical Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Clinical Trial to Evaluate the Safety and Efficacy of DW4421 in Patients With Erosive Reflux Disease | ClinicalTrials.gov |
| NCT number | NCT07931521 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 328 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Daewon Pharmaceutical Co., Ltd. | ClinicalTrials.gov |
| Conditions | Erosive Reflux Disease, GERD (Gastroesophageal Reflux Disease) | ClinicalTrials.gov |
| Interventions | DW4421 20mg, DW4421 40mg, Esomeprazole 40mg | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Cumulative healing rate of mucosal break evaluated by BICR (Blind Independent Central Review) at Week 8 after administration of the investigational product (%) | Week 8 | ClinicalTrials.gov | |
| Secondary | Cumulative healing rate of mucosal break evaluated by BICR at Week 4 after administration of the investigational product (%) | Week 4 | ClinicalTrials.gov | |
| Secondary | 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 | Weeks 4 and 8 | ClinicalTrials.gov | |
| Secondary | 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 | Weeks 4 and 8 | ClinicalTrials.gov | |
| Secondary | Proportion of subjects without primary RDQ symptoms within 24 hours after the first dose (%) | Within 24 hours | ClinicalTrials.gov | |
| Secondary | Time to first complete resolution of primary RDQ symptoms through Day 7 after the first dose, and the proportion of subjects (%) | Day 7 | ClinicalTrials.gov | |
| Secondary | Proportion of primary RDQ symptom-free days through Day 7 after the first dose (%): Daytime, Nighttime, 24-hour | Day 7 | ClinicalTrials.gov | |
| Secondary | Proportion of subjects without primary and secondary RDQ symptoms at Day 7 after the first dose (%) | Day 7 | ClinicalTrials.gov | |
| Secondary | Proportion of primary RDQ symptom-free patients at Weeks 4 and 8 after the first dose (%) | Weeks 4 and 8 | ClinicalTrials.gov | |
| Secondary | Proportion of primary RDQ symptom-free days at Weeks 4 and 8 after the first dose (%): Daytime, Nighttime, 24-hour | Weeks 4 and 8 | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)