ClinicalTrials.gg
Not yet recruitingNCT07746518Updated Aug 13, 2026

Efficacy and Safety of DWP14012 for Long-Term Maintenance Therapy in Patients With Healed Erosive Esophagitis

A Phase 3 interventional study of DWP14012 20mg and DWP14012 20 mg placebo in Healed Erosive Esophagitis, sponsored by Daewoong Pharmaceutical Co. LTD.. Not yet recruiting. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healed Erosive Esophagitis

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03

In context

Esophagitis

123 studies on the registry are indexed under Esophagitis; 15 are open to participants now.

This study's planned enrollment of 420 is above the median of 96 across 99 interventional studies indexed under Esophagitis.

Browse Esophagitis studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 200 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Adult men and women aged 19 to 75 years at the time of written
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
  • 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 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 surface antigen (HBsAg) or virus antibody (anti-HCV)
  • Subjects with hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
  • Subjects with 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 or men who do not agree to practice sexual abstinence or to use one of the acceptable methods of 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
Terms in these criteria, in plain language(8)

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.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
420 participants (estimated)

Study arms

  • Experimental
    [Double-blind Treatment Period]Treatment group(DWP14012)

    Treatment group (DWP14012 20 mg group): 1 tablet of DWP14012 20 mg + 1 capsule of DWC202517 15 mg placebo for 24 weeks

    Drug: DWP14012 20mg · Drug: DWC202517 15 mg placebo

  • Active comparator
    [Double-blind Treatment Period]Control group(DWC202517)

    1 tablet of DWP14012 20 mg placebo + 1 capsule of DWC202517 15 mg for 24weeks

    Drug: DWP14012 20 mg placebo · Drug: DWC202517 15 mg

  • Experimental
    [Open-label Extension Period]Maintenance group (DWP14012 20 mg/DWP14012 20 mg group)

    1 tablet of DWP14012 20 mg for 28weeks after Double-blind Treatment Period

    Drug: DWP14012 20mg

  • Experimental
    [Open-label Extension Period]Switch group (DWC202517 15 mg/DWP14012 20 mg group)

    1 tablet of DWP14012 20 mg for 28weeks after Double-blind Treatment Period

    Drug: DWP14012 20mg

Interventions

  • 20mg, 1 tablet, Orally, Once a day

  • DrugDWP14012 20 mg placebo

    1 tablet, Orally, Once a day

  • DrugDWC202517 15 mg

    15mg, 1 capsule, Orally, Once a day

  • DrugDWC202517 15 mg placebo

    1 capsule, Orally, Once a day

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Aug 2029, 35 months later.

Of 18 phase 3 interventional studies under Esophagitis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 34. This study's planned 35 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 31, 2026
First posted
Aug 5, 2026
StartEst.
Sep 2026
Primary completionEst.
Aug 2029
CompletionEst.
Mar 2030
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07746518
Responsible party
Sponsor
First posted
Aug 5, 2026
Start date
Sep 2026 (estimated)
Primary completion
Aug 2029 (estimated)
Completion
Mar 2030 (estimated)
Last update
Aug 13, 2026

Study contacts

Lee Coordinating Investigator
Contact
2220187@daewoong.co.kr
02)550-8800

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Fexuprazan

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