A Phase III Clinical Trial and Extension Study to Evaluate the Efficacy and Safety of DWP14012 for Maintenance Therapy in Patients With Healed Erosive Esophagitis

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Healed Erosive Esophagitis

In brief

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

Key facts

Study ID: NCT07746518
Run by: Daewoong Pharmaceutical Co. LTD.
People needed: 420
Starts: 2026-09-01
Expected to finish: 2030-03-01
Last updated by the study team: 2026-08-05

Who can join

Age: 19 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Full record on ClinicalTrials.gov

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