Actively Recruiting
A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis
Led by Livzon Pharmaceutical Group Inc. · Updated on 2025-02-27
356
Participants Needed
1
Research Sites
20 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.
CONDITIONS
Official Title
A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily participate and sign a written informed consent form, able to understand and comply with the study requirements
- Age between 18 and 75 years old
- Experienced heartburn and reflux symptoms within 7 days before screening or diagnosed with reflux esophagitis by endoscopy within 7 days before screening
- Diagnosed with grade A-D reflux esophagitis by upper gastrointestinal endoscopy within screening period
- For LA-A level subjects, acid exposure time percentage > 4% during esophageal reflux monitoring at screening
- Women of childbearing age or male partners willing to use effective contraception throughout the study
You will not qualify if you...
- Allergic to JP-1366, esomeprazole magnesium, or their components
- Unable to undergo upper gastrointestinal endoscopy
- Have gastroesophageal varices, hiatal hernia, Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome, or inflammatory bowel disease
- History of eosinophilic esophagitis or Barrett's esophagus 63 3cm confirmed by endoscopy
- Active peptic ulcers or gastrointestinal bleeding within 3 months, or unresolved after endoscopy
- Diseases affecting esophageal motility or history of esophageal radiotherapy or cryotherapy
- Previous surgery reducing gastric acid secretion or affecting esophagus, stomach, or duodenum structure/function (except minor surgeries)
- Signs of upper gastrointestinal malignancies or history of gastrointestinal malignancies (except negative endoscopy)
- History of significant diseases including hemorrhagic stroke, intracranial diseases, recurrent ulcers/bleeding, major liver disease within 1 year, recent myocardial infarction or acute coronary events, severe heart failure, serious arrhythmias, prolonged QTc interval
- History of active malignancy within 5 years (excluding certain cured cancers)
- Need for ongoing non-steroidal anti-inflammatory drugs, systemic corticosteroids, or antithrombotic drugs (except low-dose aspirin 64 100mg/day)
- Use of gastric acid inhibitors or H2 receptor blockers within 2 or 1 weeks before first dose, respectively
- Use of certain antiviral drugs at screening
- Elevated serum creatinine or reduced kidney function
- Elevated liver enzymes or bilirubin
- Participation in other systemic drug trials within 3 months or 5 half-lives of the test drug
- Pregnant or lactating women
- Investigator judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital Medical Universtiy
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
Research Team
S
Shutian Zhang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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