Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19-75
SponsorOnconic Therapeutics Inc.

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

Qualifiers

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

Treatments tested in this trial

  • JP-1366 10 mg
  • Lansoprazole 15mg

Treatment groups

384 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators