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

Last updated: February 21, 2025
Sponsor: Livzon Pharmaceutical Group Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Heartburn

Esophageal Disorders

Gastroesophageal Reflux Disease (Gerd)

Treatment

Esomeprazole Magnesium (Nexium) simulation tablets

JP-1366 simulation tablets

Clinical Study ID

NCT06850480
LZ031-301
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Age between 18-75 years old (including boundary values) during screening, both maleand 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 byendoscopic examination within 7 days before screening;

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

  5. LA-A level subjects, esophageal reflux monitoring during the screening period, acidexposure time percentage > 4%;

  6. Women of childbearing age or significant other male subjects of childbearing age arewilling to use effective contraceptive measures throughout the study period, such asoral, implanted, or injected contraceptive hormones, or use mechanical products suchas intrauterine devices or barrier methods (uterine caps, , spermicides), orpractice abstinence or self/significant other sterilization (such as vasectomy,hysterectomy, bilateral salpinectomy, or bilateral oophorectomy).

Exclusion

Exclusion Criteria:

  1. Known to be allergic to the test drug and any of its components or to esomeprazolemagnesium 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 byupper gastrointestinal endoscopy during the screening period;

  5. Screening for patients with active peptic ulcers and active upper/lowergastrointestinal bleeding within the first 3 months; or patients with a history ofactive peptic ulcers and active upper/lower gastrointestinal bleeding more than 3months after screening, and those who did not recover after endoscopic examinationof the upper gastrointestinal tract during the screening period;

  6. Patients with concomitant diseases that may affect esophageal motility (such asscleroderma, viral infection or fungal infection, etc.), or those with a history ofesophageal radiotherapy or cryotherapy;

  7. Have undergone surgery to reduce gastric acid secretion, or any surgery that affectsthe structure or function of the esophagus, stomach, or duodenum (except for benigntumor resection, benign polyp endoscopic resection, simple suture surgery such asgastric perforation);

  8. Subjects with warning symptoms of upper gastrointestinal malignancies orgastrointestinal malignancies (such as swallowing pain, severe dysphagia, bleeding,weight loss, anemia, hemoptysis or hematochezia) (except for those with negativeendoscopic 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.

Those who have had acute clinical hepatitis or a history of major liver disease (active phase of chronic hepatitis, cirrhosis, or chronic liver dysfunction) within the past year before screening.

Screening for those who have had myocardial infarction, acute coronary syndrome, viral myocarditis, or pulmonary embolism within the past 6 months; those who have undergone coronary artery revascularization within 6 months; transient ischemic attack or ischemic stroke.

Patients with a history of chronic congestive heart failure and NYHA IV heart function.

There are severe arrhythmias that require treatment with Class Ia or III antiarrhythmic drugs; arrhythmias with diseased sinus syndrome, Class II or III atrioventricular block, and pacemakers have not yet been implanted.

People with a history of prolonged QTc interval or screening period with QTc interval ≥ 480ms (according to Fridericia correction formula, where QTc = QT/RR ^ 0.33).

Subjects with any history of active malignant tumors within the first 5 years of screening (excluding cured basal cell carcinoma, papillary thyroid carcinoma, and radical resection of carcinoma in situ such as intraductal carcinoma of the and cervical carcinoma in situ).

Subjects who need to continue receiving non-steroidal anti-inflammatory drugs (such as aspirin), systemic corticosteroids, or antithrombotic drugs during the trial period (excluding those who use prophylactic low-dose aspirin (≤ 100mg/day)).

  1. Subjects who have taken gastric acid inhibitors (e.g. P-CAB, PPI) within 2 weeksbefore the first dose; or subjects who have taken H2 receptor blockers within 1 weekbefore the first dose; 13. Subjects who were using retroviral antiviral drugs suchas azanavir and nefinavir at the time of screening; 14. Those who meet any of thefollowing requirements during the screening: Serum creatinine > 1.5 × ULN; historyof chronic kidney disease, estimated glomerular filtration rate (eGFR) < 30ml/min/1.73m2.

Total bilirubin > 1.5 × ULN, alanine aminotransferase (AST)/aspartate aminotransferase (ALT) > 3 × ULN.

  1. Have participated in any systemic therapeutic drug clinical trial (defined asadministered) within the first 3 months of screening or within 5 half-lives of thetest drug (whichever is longer); 16. Pregnant or lactating women; 17. Theinvestigator determines that the subjects are not suitable to participate in thisexperiment.

Study Design

Total Participants: 356
Treatment Group(s): 2
Primary Treatment: Esomeprazole Magnesium (Nexium) simulation tablets
Phase: 3
Study Start date:
December 05, 2024
Estimated Completion Date:
April 30, 2025

Study Description

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

Connect with a study center

  • Beijing Friendship Hospital, Capital Medical Universtiy

    Beijing, Beijing 100050
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.