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

NCT06850480 | Recruiting Phase 3

• 1 other identifier: LZ031-301
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Reflux Esophagitis (RE)

Outcome Measures

Primary Outcomes (1)

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

  Week 4-8

Secondary Outcomes (7)

• Percentage of subjects with esophageal mucosal healing confirmed by upper gastrointestinal endoscopy within 4 weeks of treatment

  Week 0-4

• Changes in the severity of major symptoms (heartburn and reflux) compared to the base line at 4 and 8 weeks after treatment.

  Week 0-4 and week4-8

• Changes in the frequency of major symptoms (heartburn and reflux) compared to the base line at 4 and 8 weeks after treatment.

  Week 0-4 and week4-8

• Changes in the overall score of gastroesophageal reflux disease health-related quality of life (GERD-HRQL) compared to the base line at 4 and 8 weeks after treatment

  Week 0-4 and week4-8

• The proportion of positive answers to "treatment satisfaction" in the GERD-HRQL scale

  Week 0-8

Other Outcomes (3)

• Percentage of subjects without major symptoms (heartburn and reflux) occurring within 1 week, 4 weeks, and 8 weeks after treatment (day, night, day, and night).

  Week0-4 or Week0-8

• Percentage of days without major symptoms (heartburn and reflux) occurring within 1 week, 4 weeks, and 8 weeks after treatment (day, night, day, and night)

  Week0-4 or Week0-8

• The first time there were no major symptoms (heartburn and reflux) for 7 consecutive days after treatment

  Week0-4 or Week0-8

Study Arms (2)

JP-1366 Tablets

EXPERIMENTAL

20 mg qd, last for 4-8 weeks

Drug: Esomeprazole Magnesium (Nexium) simulation tablets

Esomeprazole magnesium Enteric Tablets

ACTIVE COMPARATOR

40 mg qd, last for 4-8 weeks

Drug: JP-1366 simulation tablets

Interventions

JP-1366 simulation tablets DRUG

qd, last for 4-8 weeks

Esomeprazole magnesium Enteric Tablets

Esomeprazole Magnesium (Nexium) simulation tablets DRUG

qd, last for 4-8 weeks

JP-1366 Tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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);
• 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).

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead

Study Sites (1)

Beijing Friendship Hospital, Capital Medical Universtiy

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Esophagitis, Peptic

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Shutian Zhang, Dr.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 27, 2025
• Study Start: December 5, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 30, 2025
• Last Updated: February 27, 2025

Record last verified: 2025-02

Locations

CN (1)