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Not Yet Recruiting
NCT07732075
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis
Conditions: Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)
Sex: All
Ages: 19 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 384
Sponsor: Onconic Therapeutics Inc.
Summary
This study aims to evaluate the Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects with Healed Erosive Esophagitis
Eligibility Criteria
Inclusion Criteria:
1. Adult males or females aged ≥19 years and ≤75 years at the time of written informed consent
2. Subjects diagnosed with erosive esophagitis according to the LA classification based on upper gastrointestinal endoscopy performed within 12 weeks prior to the Randomization Visit
3. 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
Exclusion Criteria:
1. Subjects diagnosed with upper gastrointestinal bleeding or perforation, gastric or duodenal ulcer within 4 weeks prior to the Screening
2. Subjects who have alarm symptoms suggestive of gastrointestinal malignancy at the Screening, including odynophagia, severe dysphagia, bleeding, weight loss, anemia, or hematochezia
3. 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
Source: ClinicalTrials.gov (NCT07732075). StuddyBuddy aggregates publicly available trial information.