Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis

NCT ID: NCT04531475

Last Updated: 2025-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-21
• Study Completion Date: 2021-01-12

Brief Summary

The purpose of the study is to investigate the efficacy and dose-effect relationship of X842 capsules at different dosages in the treatment of reflux esophagitis for 4 weeks in comparison with lansoprazole enteric-coated capsules.

Detailed Description

It is designed as a multicenter, randomized, double-blind, double-simulation, high and low dose group, active comparator-controlled, parallel-group study to investigate the efficacy and dose-effect relationship of X842 capsules at different dosages in the treatment of reflux esophagitis for 4 weeks in comparison with lansoprazole enteric-coated capsules.

Conditions

Reflux Esophagitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

X842 50 mg QD

X842 50 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 weeks.

Group Type: EXPERIMENTAL

X842

Intervention Type: DRUG

X842 capsules

Lansoprazole Placebo

Intervention Type: DRUG

Lansoprazole placebo-matching capsules

X842 100 mg QD

X842 100 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 weeks.

Group Type: EXPERIMENTAL

X842

Intervention Type: DRUG

X842 capsules

Lansoprazole Placebo

Intervention Type: DRUG

Lansoprazole placebo-matching capsules

Lansoprazole 30 mg QD

Lansoprazole 30 mg, capsule, orally, once daily and X842 placebo-matching capsule, orally, once daily up to 4 weeks.

Group Type: EXPERIMENTAL

X842 Placebo

Intervention Type: DRUG

X842 placebo-matching capsules

Lansoprazole

Intervention Type: DRUG

Lansoprazole capsules

Interventions

X842

X842 capsules

Intervention Type: DRUG

X842 Placebo

X842 placebo-matching capsules

Intervention Type: DRUG

Lansoprazole

Lansoprazole capsules

Intervention Type: DRUG

Lansoprazole Placebo

Lansoprazole placebo-matching capsules

Intervention Type: DRUG

Other Intervention Names

Undecided; Undecided; Undecided; Undecided

Eligibility Criteria

Inclusion Criteria

1. Males or females, 18 years ≤ age ≤ 75 years;

2. Within 14 days prior to randomization, the subjects are endoscopically diagnosed with reflux esophagitis from Los Angeles (LA) grade A to D (notes: the percent of the subjects with LA grade A of RE should be no more than 60% of the all subjects who are planned to be enrolled in the study);

3. Subjects fully understand the trial contents, participate in the trial voluntarily, and sign the informed consent forms.

15. Subjects who use proton pump inhibitors (PPIs), P-CABs, histamine2 receptor antagonists (H2RAs), or gastric mucosal protectors (except hydrotalcite) within 2 weeks prior to randomization;

16. Subjects who chronically use (>12 doses / month) non-steroidal anti-inflammatory drug (including cyclooxygenase-2 inhibitor), anti-platelet drug (such as aspirin and clopidogrel), or anticoagulant (such as Warfarin) prior to randomization, and can not stop the medication during the trial;

17. At screening, subjects with clinically significant ECG abnormalities, including serious arrhythmia, multifocal preventricular contraction (PVC), grade II or above atrioventricular block, and prolongation of the Q-T interval (QTc≥450 ms in males and QTc≥470 ms in females);

18. Diabetic subjects with poorly controlled blood glucose level (fasting blood glucose (FBG) > 10.0 mmol/L), or hypertensive subjects with poorly controlled blood pressure (systolic pressure ≥150 mmHg or diastolic pressure ≥100 mmHg);

19. Subjects with known acquired immunodeficiency syndrome (AIDS);

20. Subjects who are using atazanavir sulfate or ripivirin hydrochloride at screening;

21. Subjects with a history of long-term abuse of drug or alcohol within 6 months prior to screening;

22. Female subjects with suspicious or known pregnancy, those in breast-feeding period, or those who are planned to become pregnant during the trial. At the investigator's discretion, women of childbearing age who cannot use a medically-proven and reliable method of contraception from signing the informed consent forms to 4 weeks after the last dose of the study;

23. Subject who plan to have a surgery requiring hospitalization, or subject who need to have a surgery during his/her participation in the study;

24. Subjects who participate in other drug/medical device clinical studies and use the drug/medical device within 3 months prior to randomization;

25. Subjects who are considered unsuitable for participating in this trial by investigators.

Exclusion Criteria

1. Subjects who receive X842 capsules or other P-CAB drugs in previous clinical studies;

2. Subjects known to be allergic to X842 capsules or lansoprazole enteric-coated capsules, or relevant excipients of X842 capsules or lansoprazole enteric-coated capsules, such as lactose, microcrystalline cellulose, croscarmellose sodium, sodium dodecyl sulfate, sodium stearyl fumarate, and silicon dioxide;

3. Subjects unable to receive upper gastrointestinal endoscopy;

4. Subjects unable to independently complete the subject diary cards;

5. Subjects known to have any concomitant disease that may affect the esophagus (eosinophilic esophagitis, esophageal varices, dermatosclerosis, viral or fungal infectious esophagitis, or esophageal stenosis), or have a history of esophageal radiotherapy or cryotherapy (but subjects are eligible for this study if they have concomitant esophageal hiatal hernia)

6. Subjects known to have a history of Barrett's esophagus, or who have Barrett's esophagus discovered during endoscopy at screening;

7. Subjects who have acute upper gastrointestinal hemorrhage within 4 weeks prior to enrollment;

8. Subjects with active peptic ulcer discovered during upper gastrointestinal endoscopy, or subjects with suspicious or definite malignancies;

9. Subjects known to have Zollinger-Ellison syndrome or inflammatory bowel disease (IBD);

10. Subjects with concomitant cholecystolithiasis, gallbladder wall crystal or gallbladder polyp discovered by B ultrasonography at screening;

11. Subjects with a history of surgery that may affect the esophagus (for example, fundoplication and mechanical distension for esophageal stenosis), or subjects with a history of cholecystectmy or surgery of stomach or duodenum (except endoscopic excision of benign polyps, and except simple suture surgeries such as for gastric perforation);

12. Subjects with a history of malignancies within 5 years prior to screening (a subject can participate in the study if his /her skin basal cell carcinoma or carcinoma in situ of uterine cervix has been cured);

13. Subjects with concomitant serious diseases of central nervous system, cardiovascular system, respiratory system, liver, kidney, gastrointestinal tract, urinary system, endocrine system, or hematological system, and the investigator thinks these diseases may mix the study results up or affect the safety of the subject;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Sinorda Biomedicine Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pingsheng Hu, Ph.D

Role: STUDY_CHAIR

Jiangsu Sinorda Biomedicine Co., Ltd

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Liuan People's Hospital

Liu‘an, Anhui, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

The Affiliated Hospital of Guzihou Medical University

Guiyang, Guizhou, China

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Affiliated Hospital of Xiangnan University

Chenzhou, Hunan, China

The First people's Hospital of Changzhou

Changzhou, Jiangsu, China

Nanjing First Hospital

Nanjing, Jiangsu, China

Jiangxi PingXiang People's Hospital

Pingxiang, Jiangxi, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

Jinan Central Hospital

Jinan, Shandong, China

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, China

The Second Affiliated Hospital of Chongqi Medical University

Chongqing, Sichuan, China

Taizhou Municipal Hospital

Taizhou, Zhejiang, China

Beijing Luhe Hospital Capital Medical University

Beijing, , China

Countries

China

References

Zhu S, Han M, Zong Y, Meng F, Liu Q, Tuo B, Zhang Z, Wang Q, Liu X, He S, Zhen Y, Shao D, Wang S, Xu B, Li X, Tang H, Miu Y, Liu C, Hu J, Hu P, Xiu J, Lu M, Wu Y, Zhang S. A Randomized, Comparative Trial of a Potassium-Competitive Acid Blocker (X842) and Lansoprazole for the Treatment of Patients With Erosive Esophagitis. Clin Transl Gastroenterol. 2025 Apr 1;16(4):e00803. doi: 10.14309/ctg.0000000000000803.

Reference Type: DERIVED

PMID: 39836012 (View on PubMed)

Other Identifiers

SND-X842-201

Identifier Type: -

Identifier Source: org_study_id