Healed Erosive EsophagitisPhase 3NCT07746518
Efficacy and Safety of DWP14012 for Long-Term Maintenance Therapy in Patients With Healed Erosive Esophagitis
A Phase 3 study testing DWP14012 20mg and DWC202517 15 mg in people with Healed Erosive Esophagitis, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
A Multi-center, Double-blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial and Open-label Extension Study to Evaluate the Efficacy and Safety of DWP14012 for Maintenance Therapy in Patients with Healed Erosive Esophagitis Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Healed Erosive Esophagitis
- What is being tested?
- DWP14012 20mg and DWC202517 15 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Mar 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women aged 19 to 75 years at the time of written informed consent
- Diagnosed with EE on an upper gastrointestinal endoscopy prior to the initiation of standard therapy
- Healing of EE confirmed by upper gastrointestinal endoscopy performed prior to Visit 2 (Randomization), defined as the absence of mucosal breaks according to the LA Grade classification, after completion of standard therapy
- Able to understand the information provided and complete the questionnaire
- Has voluntarily decided to participate in this clinical trial and has provided written informed consent
Who cannot join
- Presence of heartburn or acid regurgitation within 7 days prior to Visit 2 (Randomization)
- On screening upper gastrointestinal endoscopy, presence of Barrett's esophagus (>3 cm), esophageal varices, esophageal stricture, ulcer-related stricture, active peptic ulcer, acute gastrointestinal bleeding, or malignancy
- Patients with inflammatory bowel disease , irritable bowel syndrome, primary esophageal motility disorder, or pancreatitis
- History of gastric acid secretion-inhibiting surgery or surgery on the stomach/esophagus (e.g., gastrectomy, endoscopic mucosal resection) or total small bowel resection
- Presence of alarm symptoms suggestive of gastrointestinal malignancy
- Patients with Zollinger-Ellison syndrome
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- Patients with eosinophilic esophagitis
- Subjects with diseases of the liver, kidney, nervous system, respiratory system, endocrine system, hematologic/oncologic system, cardiovascular system, or urinary system that, in the investigator's judgment, render them unsuitable for participation in this clinical trial
- Subjects with a history of malignancy within the past 5 years
- Subjects with a history of clinically significant psychiatric disorders.
- Subjects with a history of drug or alcohol abuse within the past year.
- Subjects diagnosed with Acquired Immune Deficiency Syndrome (AIDS).
- Subjects who test positive for either Hepatitis B surface antigen (HBsAg) or Hepatitis C virus antibody (anti-HCV)
- Subjects with hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Subjects with hypersensitivity to any component of the IP or to benzimidazole-class drugs, or with a clinically significant history of hypersensitivity
- Subjects who require continuous administration of any of the following medications(e.g. PPI, P-CAB, H2RAs, NSAIDs etc.) during the clinical trial period
- Subjects who have received any other IP prior to administration of the IP
- Subjects who meet any of the following criteria based on screening laboratory test results
- Subjects who are unable to discontinue their current treatment for EE.
- Subjects who have planned surgery requiring hospitalization that may affect gastric acid secretion or who require surgical treatment during the clinical trial period
- Pregnant or breastfeeding women
- Women of childbearing potential or men who do not agree to practice sexual abstinence or to use one of the acceptable methods of contraception during the clinical trial period and for 2 weeks after the last dose of the IP
- Subjects unable to undergo upper gastrointestinal endoscopy
- Subjects who, in the investigator's medical judgment, are considered unsuitable for participation in this clinical trial
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multi-center, Double-blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial and Open-label Extension Study to Evaluate the Efficacy and Safety of DWP14012 for Maintenance Therapy in Patients With Healed Erosive Esophagitis
A Multi-center, Double-blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial and Open-label Extension Study to Evaluate the Efficacy and Safety of DWP14012 for Maintenance Therapy in Patients with Healed Erosive Esophagitis
- Conditions
- Healed Erosive Esophagitis
- Being tested
- DWP14012 20mg, DWP14012 20 mg placebo, DWC202517 15 mg, DWC202517 15 mg placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012 20mgDrug
20mg, 1 tablet, Orally, Once a day
DWP14012 20 mg placeboDrug
1 tablet, Orally, Once a day
DWC202517 15 mgDrug
15mg, 1 capsule, Orally, Once a day
DWC202517 15 mg placeboDrug
1 capsule, Orally, Once a day
| Study group | Role | What they receive |
|---|---|---|
| [Double-blind Treatment Period]Treatment group(DWP14012) | Experimental | Treatment group (DWP14012 20 mg group): 1 tablet of DWP14012 20 mg + 1 capsule of DWC202517 15 mg placebo for 24 weeks Receives: Drug: DWP14012 20mg; Drug: DWC202517 15 mg placebo |
| [Double-blind Treatment Period]Control group(DWC202517) | Active comparator | 1 tablet of DWP14012 20 mg placebo + 1 capsule of DWC202517 15 mg for 24weeks Receives: Drug: DWP14012 20 mg placebo; Drug: DWC202517 15 mg |
| [Open-label Extension Period]Maintenance group (DWP14012 20 mg/DWP14012 20 mg group) | Experimental | 1 tablet of DWP14012 20 mg for 28weeks after Double-blind Treatment Period Receives: Drug: DWP14012 20mg |
| [Open-label Extension Period]Switch group (DWC202517 15 mg/DWP14012 20 mg group) | Experimental | 1 tablet of DWP14012 20 mg for 28weeks after Double-blind Treatment Period Receives: Drug: DWP14012 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (%) of subjects who maintain endoscopic remission* up to Week 24, as assessed by an independent central reader, after administration of the IP
Measured: Week 24
Secondary outcomes (2)
Proportion (%) of subjects who maintain endoscopic remission* up to Week 24, as assessed by the investigator, after administration of the IP
Measured: Week 24
Proportion (%) of subjects who maintain endoscopic remission* up to Week 12, as assessed by an independent central reader and the investigator, after administration of the IP
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2029 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healed Erosive EsophagitisStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 (Double-blind Treatment Period) Multi-center, double-blind, randomized, active-controlled, parallel-group, Phase III clinical trial Part 2 (Open-label Extension Period) Open-label
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07746518
- Sponsor's protocol ID
- DW_DWP14012314
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial and Open-label Extension Study to Evaluate the Efficacy and Safety of DWP14012 for Maintenance Therapy in Patients With Healed Erosive Esophagitis
- ClinicalTrials.gov ID
- NCT07746518
- Acronym / sponsor ID
- DW_DWP14012314
- Conditions
- Healed Erosive Esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 5 Aug 2026 (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.
A Multi-center, Double-blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial and Open-label Extension Study to Evaluate the Efficacy and Safety of DWP14012 for Maintenance Therapy in Patients with Healed Erosive Esophagitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Part 1 (Double-blind Treatment Period) Multi-center, double-blind, randomized, active-controlled, parallel-group, Phase III clinical trial Part 2 (Open-label Extension Period) Open-label
| Arm | Type | Receives |
|---|---|---|
| [Double-blind Treatment Period]Treatment group(DWP14012) | Experimental | Drug: DWP14012 20mg, Drug: DWC202517 15 mg placeboTreatment group (DWP14012 20 mg group): 1 tablet of DWP14012 20 mg + 1 capsule of DWC202517 15 mg placebo for 24 weeks |
| [Double-blind Treatment Period]Control group(DWC202517) | Active comparator | Drug: DWP14012 20 mg placebo, Drug: DWC202517 15 mg1 tablet of DWP14012 20 mg placebo + 1 capsule of DWC202517 15 mg for 24weeks |
| [Open-label Extension Period]Maintenance group (DWP14012 20 mg/DWP14012 20 mg group) | Experimental | Drug: DWP14012 20mg1 tablet of DWP14012 20 mg for 28weeks after Double-blind Treatment Period |
| [Open-label Extension Period]Switch group (DWC202517 15 mg/DWP14012 20 mg group) | Experimental | Drug: DWP14012 20mg1 tablet of DWP14012 20 mg for 28weeks after Double-blind Treatment Period |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult men and women aged 19 to 75 years at the time of written informed consent
- Diagnosed with EE on an upper gastrointestinal endoscopy prior to the initiation of standard therapy
- Healing of EE confirmed by upper gastrointestinal endoscopy performed prior to Visit 2 (Randomization), defined as the absence of mucosal breaks according to the LA Grade classification, after completion of standard therapy
- Able to understand the information provided and complete the questionnaire
- Has voluntarily decided to participate in this clinical trial and has provided written informed consent
Key exclusion criteria (24 listed)
- Presence of heartburn or acid regurgitation within 7 days prior to Visit 2 (Randomization)
- On screening upper gastrointestinal endoscopy, presence of Barrett's esophagus (>3 cm), esophageal varices, esophageal stricture, ulcer-related stricture, active peptic ulcer, acute gastrointestinal bleeding, or malignancy
- Patients with inflammatory bowel disease , irritable bowel syndrome, primary esophageal motility disorder, or pancreatitis
- History of gastric acid secretion-inhibiting surgery or surgery on the stomach/esophagus (e.g., gastrectomy, endoscopic mucosal resection) or total small bowel resection
- Presence of alarm symptoms suggestive of gastrointestinal malignancy
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 |
|---|---|---|
| DWP14012 20mg20mg, 1 tablet, Orally, Once a day | Drug | [Double-blind Treatment Period]Treatment group(DWP14012), [Open-label Extension Period]Maintenance group (DWP14012 20 mg/DWP14012 20 mg group), [Open-label Extension Period]Switch group (DWC202517 15 mg/DWP14012 20 mg group) |
| DWP14012 20 mg placebo1 tablet, Orally, Once a day | Drug | [Double-blind Treatment Period]Control group(DWC202517) |
| DWC202517 15 mg15mg, 1 capsule, Orally, Once a day | Drug | [Double-blind Treatment Period]Control group(DWC202517) |
| DWC202517 15 mg placebo1 capsule, Orally, Once a day | Drug | [Double-blind Treatment Period]Treatment group(DWP14012) |
Primary outcome
Proportion (%) of subjects who maintain endoscopic remission* up to Week 24, as assessed by an independent central reader, after administration of the IP
Time frame: Week 24
2 secondary outcomes
Proportion (%) of subjects who maintain endoscopic remission* up to Week 24, as assessed by the investigator, after administration of the IP
Time frame: Week 24
Proportion (%) of subjects who maintain endoscopic remission* up to Week 12, as assessed by an independent central reader and the investigator, after administration of the IP
Time frame: Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Healed Erosive Esophagitis
Not yet recruitingPhase 3
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis
Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWP14012 20mg and DWC202517 15 mg in people with Healed Erosive Esophagitis, run by Daewoong Pharmaceutical Co. LTD..
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 5 inclusion and 24 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: opening soon, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lee Coordinating Investigator (02)550-8800, 2220187@daewoong.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (%) of subjects who maintain endoscopic remission* up to Week 24, as assessed by an independent central reader, after administration of the IP (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.