About this trial
This study aims to evaluate the Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects with Healed Erosive Esophagitis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult males or females aged ≥19 years and ≤75 years at the time of written informed consent
Subjects diagnosed with erosive esophagitis according to the LA classification based on upper gastrointestinal endoscopy performed within 12 weeks prior to the Randomization Visit
Subjects who have received a PPI or P-CAB for at least 4 weeks after diagnosis of erosive esophagitis confirmed by upper gastrointestinal endoscopy performed within 12 weeks prior to the Randomization Visit
Disqualifiers
Subjects diagnosed with upper gastrointestinal bleeding or perforation, gastric or duodenal ulcer within 4 weeks prior to the Screening
Subjects who have alarm symptoms suggestive of gastrointestinal malignancy at the Screening, including odynophagia, severe dysphagia, bleeding, weight loss, anemia, or hematochezia
Subjects diagnosed with diseases affecting the esophagus identified by upper gastrointestinal endoscopy at the Screening, including Barrett's esophagus, esophageal dysplasia, esophageal stricture, ulcerative or pyloric stricture, gastroesophageal varices, malignancy, or viral or fungal infection
Trial design
Parallel
Treatments tested in this trial
JP-1366 10 mg
DrugOrally, once daily
Lansoprazole 15mg
DrugOrally, once daily
Treatment groups
Trial outcomes
Primary outcomes
The proportion of subjects with maintained healing of erosive esophagitis confirmed by upper gastrointestinal endoscopy at Week 24
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: