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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Proportion (%) of subjects who maintain endoscopic remission* up to Week 24, as assessed by an independent central reader, after administration of the IP [Срок оценки: Week 24]

Вторичные конечные точки (2)

• Proportion (%) of subjects who maintain endoscopic remission* up to Week 24, as assessed by the investigator, after administration of the IP [Срок оценки: 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 [Срок оценки: Week 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07746518 · DW_DWP14012314

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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