Loading clinical trials...

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

RECRUITINGPHASE3

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

A Multicenter, Randomized, Double-blind, Double-simulated, Positive Parallel-control Phase III Clinical Trails of JP-1366（Zastaprazan Citrate） Tablets and Nexium® on Reflux Esophagitis

NCT06850480•Livzon Pharmaceutical Group Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntarily participate and sign a written informed consent form, and be able to understand the information provided and comply with the program requirements;
•2. Age between 18-75 years old (including boundary values) during screening, both male and female are acceptable.
•3. 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;
•4. 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).
•5. LA-A level subjects, esophageal reflux monitoring during the screening period, acid exposure time percentage \> 4%;
•6. 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

•1. Known to be allergic to the test drug and any of its components or to esomeprazole magnesium and its components;
•2. Those who cannot accept upper gastrointestinal endoscopy;
•3. Patients with gastroesophageal varices, hiatal hernia, Zollinger-Ellison syndrome, achalasia, irritable bowel syndrome or inflammatory bowel disease;
•4. History of eosinophilic esophagitis and Barrett's esophagus (≥ 3cm), confirmed by upper gastrointestinal endoscopy during the screening period;
•5. 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;
•6. 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;
•7. 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);
•8. 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);
•9. People with a history of the following clinically significant diseases:
•Those with a history of hemorrhagic stroke or any of the following intracranial diseases (bleeding, tumors, arteriovenous malformations (AVMs), or aneurysms); There are recurrent upper gastrointestinal or gastrointestinal ulcers/bleeding, and researchers believe that there is an increased risk of bleeding or clinical bleeding has occurred within the past 6 months before screening.
+10 more criteria

Locations (1)

Beijing Friendship Hospital, Capital Medical Universtiy

Beijing, Beijing Municipality, China

Key Dates

Start Date

December 5, 2024

Primary Completion Date

April 15, 2025

Completion Date

April 30, 2025

Last Updated

February 27, 2025

Enrollment

356

ESTIMATED participants

Conditions

Reflux Esophagitis (RE)

Interventions

JP-1366 simulation tablets

DRUG

Esomeprazole Magnesium (Nexium) simulation tablets

DRUG

Contacts

Shutian Zhang, Dr.

CONTACT

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

A Clinical Trial of Anaprazole for Treating Reflux Esophagitis.

NCT07010107

Reflux Esophagitis (RE)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions