Heartburn, Gastroesophageal Reflux Disease

Официальное название

A Multicenter, Double-blind, Randomized, Investigator-initiated Trial to Evaluate the Degree of Symptom Relief of Zastaprazan and Esomeprazole in Patients With Erosive Reflux Disease With Night-time Heartburn Symptoms

Обзор

Gastroesophageal reflux disease (GERD) is a condition caused by the reflux of stomach contents into the esophagus, presenting with typical symptoms such as heartburn and acid regurgitation. GERD is a chronic condition that affects quality of life, and patients with this condition are known to have a lower quality of life compared to healthy individuals. In particular, nocturnal heartburn can lead to sleep deprivation and affect daily life, as well as overall quality of life. This study aims to evaluate the efficacy of alleviating nocturnal heartburn symptoms in patients with erosive reflux disease (ERD).

Подробное описание

This multicenter, double-blind, randomized, active-controlled Phase 4 study aims to exploratorily evaluate the comparative effects and safety of zastaprazan 20 mg and esomeprazole 40 mg in subjects with gastroesophageal reflux disease.

Вмешательства

• Препарат Zastaprazan
  Participants in this arm will receive zastaprazan. This group serves as the experimental treatment group exploratorily evaluating drug for GERD.
• Препарат Esomeprazole
  Participants in this arm will receive esomeprazole. This group serves as the active comparator treatment group exploratorily evaluating drug for GERD.

Первичные конечные точки

• Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days [Срок оценки: Week 2]

Вторичные конечные точки (4)

• Proportion of participants without sleep disturbance related to nighttime heartburn during the last 7 days [Срок оценки: Week 4]
• Mean change from baseline in Gastroesophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) score [Срок оценки: Baseline, Week 2, Week 4]
• Mean change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) score [Срок оценки: Baseline, Week 2, Week 4]
• Change from baseline in Gastroesophageal Reflux Disease Questionnaire (GerdQ) score [Срок оценки: Baseline, Week 2, Week 4]

Критерии участия

Критерии включения

• Korean adults aged 19 years or older as of the date of written consent
• Those diagnosed with erosive gastroesophageal reflux disease based on upper gastrointestinal endoscopy (EGD)
• Those who reported nighttime heartburn for more than 3 months at the time of screening (Visit 1)
• Those who voluntarily decided to participate and provide written informed consent

Критерии исключения

• Those who cannot undergo upper gastrointestinal endoscopy (EGD)
• Individuals with a history of drug or alcohol abuse (within the past year)
• Individuals who have received other investigational products within one month prior to the screening visit (Visit 1)
• In addition to the above, individuals with clinically significant findings that the investigator deems medically inappropriate for the present study

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

Двойное слепое

Основная цель

Другое

Центры проведения

South Korea · 10 центров

• Korea University Ansan Hospital — Ansan
• Pusan National University Hospital — Busan
• Kyungpook National University Chilgok Hospital — Chilgok
• Hallym University Chuncheon Sacred Heart Hospital — Chuncheon
• Chonnam National University Hospital — Gwangju
• Catholic University of Korea, Incheon ST. Mary's Hospital — Incheon
• Gangnam Severance Hospital — Seoul
• Kyung Hee University Hospital — Seoul
• … и ещё 2 центра

Идентификаторы

NCT: NCT07268820 · JL-JAQ-402

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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