Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2025-12-24 @ 3:27 PM
NCT ID:
NCT03943992
Eligibility Criteria:
Inclusion Criteria:
* A man or woman over 20 years old less than 70 years old.
* A man or woman who has experienced symptom (heartburn and acid regurgitation) within 7 days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as Erosive esophagitis(LA grade A\~D) measured through the endoscopy which is carried out within (-2W±D2)
\* Symptom (heartburn and acid regurgitation) is confirmed by RDQ.
1. Experienced above 2 days in 1 week, Heartburn of acid regurgitation above the weakness.
2. Experienced above 1 day in 1 week, Heartburn of acid regurgitation above the middle.
* A man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial.
Exclusion Criteria:
* Who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole.
* Who has NERD
* Who get a diagnosis as a IBS within the last 3 months.
* Who have taken gastric acid secretion inhibitors including PPIs within 2 weeks before the endoscopy.
* Who have taken drugs about reflux esophagitis (H₂-receptor inhibitor (H2RA) Prostaglandin(PG), Antacid, Prokinetic acid etc.) above 2 times as an usual dose. (\* refer to the Concomitant medication in text.)
* Who has been experienced the disease affecting the esophagus(Eosinophilic esophagitis, esophageal varices, cirrhosis, Virus or Fungal infection, Esophageal stricture, primary esophageal motility disorder and gastrointestinal bleeding). Or who has a history of radio therapeutics, freeze treatment about the esophagus.
* Who has clinically significant abnormal result of ECG.
* Abnormal result of Major arrhythmia, Multifocal PVS, 2 AV-blcok etc.
* Who has the Schatzki near the LES(lower esophageal sphincter) except the Barret's esophagus.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT03943992
Study Brief:
Protocol Section:
NCT03943992