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 range18 Years – 75 Years

SexALL

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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

✕. 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);

What they're measuring

Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 8 weeks of treatment

Timeframe: Week 4-8

Trial details

NCT IDNCT06850480

SponsorLivzon Pharmaceutical Group Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-15

Contact for this trial

Shutian Zhang, Dr.

+86-010-63016616 zhangst@ccmu.edu.cn

View on ClinicalTrials.gov More Reflux Esophagitis (RE) trials