A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLivzon Pharmaceutical Group Inc.

About this trial

To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.

Eligibility criteria

Qualifiers

Voluntarily participate and sign a written informed consent form, and be able to understand the information provided and comply with the program requirements;

Age between 18-75 years old (including boundary values) during screening, both male and female are acceptable.

Those who have experienced heartburn and reflux symptoms (with medical records) within 7 days before screening or who have been diagnosed with reflux esophagitis by endoscopic examination within 7 days before screening;

Screening period for upper gastrointestinal endoscopy, diagnosed with grade A-D reflux esophagitis in Los Angeles (those who have received endoscopic examination results from our center, have been judged by researchers to meet the diagnostic criteria, and have not been examined within 14 days before randomization, do not need to repeat this examination).

Disqualifiers

Known to be allergic to the test drug and any of its components or to esomeprazole magnesium and its components;

Those who cannot accept upper gastrointestinal endoscopy;

Patients with gastroesophageal varices, hiatal hernia, Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome or inflammatory bowel disease;

History of eosinophilic esophagitis and Barrett's esophagus (≥ 3cm), confirmed by upper gastrointestinal endoscopy during the screening period;

Trial design

Treatments tested in this trial

  • JP-1366 simulation tablets
  • Esomeprazole Magnesium (Nexium) simulation tablets

Treatment groups

356 Participants
are divided into 2 treatment groups