The Phase III Clinical Trial of X842 Capsules for Reflux Esophagitis

NCT ID: NCT07079540

Last Updated: 2025-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 380 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-24
• Study Completion Date: 2022-12-01

Brief Summary

To evaluate the efficacy and safety of X842 Capsules 50 mg compared to Lansoprazole Enteric Capsules for the treatment of reflux esophagitis, and to characterize the population pharmacokinetics of X842 capsules in this patient population.

Detailed Description

This study uses a multicenter, randomized, double-blind, double-dummy, active-controlled parallel-group, non-inferiority design to compare the efficacy and safety of X842 capsules (50 mg) in the treatment of reflux esophagitis over 4 to 8 weeks in comparison with lansoprazole enteric-coated capsules(30 mg) . Additionally, the population pharmacokinetics characteristics of X842 capsules in patients with reflux esophagitis is observed.

Conditions

Reflux Esophagitis

Study Design

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

Study Groups

X842 50mg QD

X842 50 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 to 8 weeks.

Group Type: EXPERIMENTAL

X842

Intervention Type: DRUG

X842 capsules

Lansoprazole Placebo

Intervention Type: DRUG

Lansoprazole placebo-matching capsules

lansoprazole 30mg QD

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

Group Type: ACTIVE_COMPARATOR

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

X842 capsules; Lansoprazole capsules

Eligibility Criteria

Inclusion Criteria

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

2. Within 7 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 20% of the all subjects who are planned to be enrolled in the study);

3. Subjects who can independently complete the subject diary cards;

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

14. Subjects who use of therapeutic doses of GERD medications within 7 days prior to randomization, eg. proton pump inhibitors (PPIs), P-CABs, histamine2 receptor antagonists (H2RAs), or gastric mucosal protectors (except hydrotalcite), prokinetic drugs, and traditional Chinese medicines;

15. Subjects who chronically use 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;

16. At screening, subjects with clinically significant ECG abnormalities, including serious arrhythmia, multifocal ventricular premature complexes, grade II or above atrioventricular block, and prolongation of the Q-Tc interval (QTc≥450 ms in males and QTc≥470 ms in females);

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

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

19. Female subjects with 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;

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

21. 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. Endoscopic examination revealed concomitant diseases potentially affecting the esophagus, excluding hiatal hernia, and excluding Barrett's esophagus with metaplastic columnar epithelium that either does not involve the entire esophageal circumference or is short-segment (< 3 cm in length).

5. Patients with rheumatic/autoimmune diseases potentially affecting esophageal motility (e.g., scleroderma, undifferentiated connective tissue disease), or those with a history of esophageal radiotherapy or cryotherapy;

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

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

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

9. Subjects with history of surgery affecting the structure or function of the esophagus, stomach, or duodenum, or surgery altering gastric acid secretion.

10. Subjects who plan to undergo surgical procedures during the study period that may alter gastric acid secretion (e.g., abdominal surgery, vagotomy, or craniectomy).

11. 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);

12. 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

Liuan People's Hospital

Liu‘an, Anhui, China

Xuancheng People's Hospital

Xuancheng, Anhui, China

The 900th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China

Fuzhou, Fujian, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Huizhou Central People's Hospital

Huizhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Liuzhou Worker's Hospital

Liuzhou, Guangxi, China

The Second Nanning People's Hospital

Nanjing, Guangxi, China

The Affiliated Hospital of Guzihou Medical University

Guiyang, Guizhou, China

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Hainan General Hospital

Haikou, Hainan, China

Cangzhou Central Hospital

Cangzhou, Hebei, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Zhengzhou People's Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Taihe Hospital of Shiyan City

Shiyan, Hubei, China

Affiliated Union Hospital, Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

The First People's Hospital of Chenzhou City

Chenzhou, Hunan, China

The Second Affiliated Hospital of South China University

Hengyang, Hunan, China

The First Affiliated Hospital Of University Of South China

Hengyang, Hunan, China

Huai 'an First People's Hospital

Huaian, Jiangsu, China

The First People's Hospital of Lianyungang

Lianyungang, Jiangsu, China

Zhongda Hospital of Southeast University

Nanjing, Jiangsu, China

Wuxi People's Hospital

Wuxi, Jiangsu, China

Affiliated Hospital of Yangzhou University(Yangzhou First People's Hospital)

Yangzhou, Jiangsu, China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Pingxiang People's Hospital

Pingxiang, Jiangxi, China

The Second Hospital of Jilin University

Changchun, Jinlin, China

The First Hospital of Jilin University

Changchun, Jinlin, China

Shengjing Hospital Of China Medical University

Shenyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Affiliated Hospital of Binzhou Medical University

Binzhou, Shandong, China

Jinan Central Hospital

Ji'nan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Zigong Fourth People's Hospital

Zigong, Sichuan, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Peking University Third Hospital

Beijing, , China

Beijing Luhe Hospital Capital Medical University

Beijing, , China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Chongqing University Three Gorges Hospital

Chongqing, , China

Tongji Hospital Affiliated to Tongji University

Shanghai, , China

Shanghai East Hospital

Shanghai, , China

Nankai Hospital of Tianjin City

Tianjin, , China

Countries

China

Other Identifiers

ChiCTR20210736

Identifier Type: OTHER

Identifier Source: secondary_id

SND-X842-301

Identifier Type: -

Identifier Source: org_study_id