A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esopha… (NCT06850480) | Clinical Trial Compass
RecruitingPhase 3
A Phase III Clinical Trial for Efficacy and Safety Evaluation of JP-1366 Tablets on Reflux Esophagitis
China356 participantsStarted 2024-12-05
Plain-language summary
To evaluate the efficacy and safety of JP-1366 tablets and Nexium® (Esomeprazole magnesium enteric-coated tablets) in subjects with reflux esophagitis.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
. LA-A level subjects, esophageal reflux monitoring during the screening period, acid exposure time percentage \> 4%;
. Women of childbearing age or significant other male subjects of childbearing age are willing to use effective contraceptive measures throughout the study period, such as oral, implanted, or injected contraceptive hormones, or use mechanical products such as intrauterine devices or barrier methods (uterine caps, , spermicides), or practice abstinence or self/significant other sterilization (such as vasectomy, hysterectomy, bilateral salpinectomy, or bilateral oophorectomy).
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 8 weeks of treatment
. 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;
. Screening for patients with active peptic ulcers and active upper/lower gastrointestinal bleeding within the first 3 months; or patients with a history of active peptic ulcers and active upper/lower gastrointestinal bleeding more than 3 months after screening, and those who did not recover after endoscopic examination of the upper gastrointestinal tract during the screening period;
. Patients with concomitant diseases that may affect esophageal motility (such as scleroderma, viral infection or fungal infection, etc.), or those with a history of esophageal radiotherapy or cryotherapy;
. Have undergone surgery to reduce gastric acid secretion, or any surgery that affects the structure or function of the esophagus, stomach, or duodenum (except for benign tumor resection, benign polyp endoscopic resection, simple suture surgery such as gastric perforation);
. Subjects with warning symptoms of upper gastrointestinal malignancies or gastrointestinal malignancies (such as swallowing pain, severe dysphagia, bleeding, weight loss, anemia, hemoptysis or hematochezia) (except for those with negative endoscopic malignancies);