Not yet recruiting NCT07746518

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

Phase III Interventional Healed Erosive Esophagitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: DWP14012 20mg, DWP14012 20 mg placebo, DWC202517 15 mg, DWC202517 15 mg placebo.
Who it may be relevant to: Registry conditions: Healed Erosive Esophagitis. Basic parameters: 19 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

Interventions

Drug DWP14012 20mg
20mg, 1 tablet, Orally, Once a day
Drug DWP14012 20 mg placebo
1 tablet, Orally, Once a day
Drug DWC202517 15 mg
15mg, 1 capsule, Orally, Once a day
Drug DWC202517 15 mg placebo
1 capsule, Orally, Once a day

Primary outcome measures

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 outcome measures (2)

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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07746518 · DW_DWP14012314

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗