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Can a new pill keep stomach acid damage at bay?

NCT ID NCT07746518

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 05, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This trial is testing an experimental drug called DWP14012 to see if it can prevent erosive esophagitis—a condition where stomach acid damages the esophagus—from coming back after it has healed. About 420 adults aged 19 to 75 with healed erosive esophagitis will take either DWP14012 or an active comparison drug daily for up to 24 weeks. The main goal is to see how many people stay in remission, meaning their esophagus remains healed, during that time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DWP14012 (an experimental acid-reducing drug)
What this could lead to
If successful, DWP14012 could offer a new option for people with healed erosive esophagitis to prevent the condition from coming back, potentially improving long-term management.
What could go wrong
This is a phase III trial, but results are not yet known. The drug may not be more effective than existing treatments, and side effects are possible. Success in this trial does not guarantee regulatory approval.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 420 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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 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 * 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

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    Open the record ↗

  2. A doctor treating you

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