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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
China
Beijing Friendship Hospital, Capital Medical Universtiy
RECRUITING
Beijing
Contact Information
Primary
Shutian Zhang, Dr.
zhangst@ccmu.edu.cn
+86-010-63016616
Time Frame
Start Date: 2024-12-05
Estimated Completion Date: 2025-04-30
Participants
Target number of participants: 356
Treatments
Experimental: JP-1366 Tablets
20 mg qd, last for 4-8 weeks
Active_comparator: Esomeprazole magnesium Enteric Tablets
40 mg qd, last for 4-8 weeks
Sponsors
Leads: Livzon Pharmaceutical Group Inc.

This content was sourced from clinicaltrials.gov

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