The Phase III Clinical Trial of X842 Capsules for Reflux Esophagitis
X842
A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Phase III Clinical Study to Evaluate the Efficacy and Safety of X842 Capsules in Patients With Reflux Esophagitis
2 other identifiers
interventional
380
1 country
53
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2021
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 14, 2025
CompletedFirst Posted
Study publicly available on registry
July 23, 2025
CompletedJuly 23, 2025
July 1, 2025
1.1 years
July 14, 2025
July 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 8
Healing of reflux esophagitis is defined as endoscopic confirmation of resolved esophagitis (absence of esophageal mucosal breaks) in subjects.
8 weeks
Secondary Outcomes (12)
Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 4
4 weeks
Improvement rate in the frequency and severity of individual clinical symptoms (heartburn, regurgitation) of reflux esophagitis at Weeks 2, 4, and 8 after treatment initiation.
2,4,8 weeks
Response rates for individual symptom domains (heartburn, regurgitation) in reflux esophagitis at Weeks 2, 4, and 8 post-baseline.
2.4.8 weeks
Overall symptomatic resolution rate for reflux esophagitis at Weeks 2, 4, and 8
2,4,8 weeks
Change in serum gastrin levels from baseline at Weeks 4 and 8 of treatment
4, 8 weeks
- +7 more secondary outcomes
Study Arms (2)
X842 50mg QD
EXPERIMENTALX842 50 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 to 8 weeks.
lansoprazole 30mg QD
ACTIVE COMPARATORLansoprazole 30 mg, capsule, orally, once daily and X842 placebo-matching capsule, orally, once daily up to 4 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Males or females, 18 years ≤ age ≤ 75 years;
- 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);
- Subjects who can independently complete the subject diary cards;
- Subjects fully understand the trial contents, participate in the trial voluntarily, and sign the informed consent forms.
You may not qualify if:
- Subjects who receive X842 capsules or other P-CAB drugs in previous clinical studies;
- 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;
- Subjects unable to receive upper gastrointestinal endoscopy;
- 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).
- 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;
- Subjects who have acute upper gastrointestinal hemorrhage within 4 weeks prior to enrollment;
- Subjects with active peptic ulcer discovered during upper gastrointestinal endoscopy, or subjects with suspicious or definite malignancies;
- Subjects known to have Zollinger-Ellison syndrome or inflammatory bowel disease (IBD);
- Subjects with history of surgery affecting the structure or function of the esophagus, stomach, or duodenum, or surgery altering gastric acid secretion.
- Subjects who plan to undergo surgical procedures during the study period that may alter gastric acid secretion (e.g., abdominal surgery, vagotomy, or craniectomy).
- 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);
- 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;
- 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;
- 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;
- 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);
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Liuan People's Hospital
Liu‘an, Anhui, 237016, China
Xuancheng People's Hospital
Xuancheng, Anhui, 242000, China
The 900th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China
Fuzhou, Fujian, 350001, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Huizhou Central People's Hospital
Huizhou, Guangdong, 516000, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529000, China
Meizhou People's Hospital
Meizhou, Guangdong, 514031, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, 545005, China
The Second Nanning People's Hospital
Nanjing, Guangxi, 530031, China
The Affiliated Hospital of Guzihou Medical University
Guiyang, Guizhou, 550004, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003, China
Zhengzhou People's Hospital
Zhengzhou, Henan, 450003, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Taihe Hospital of Shiyan City
Shiyan, Hubei, 442700, China
Affiliated Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430022, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The First People's Hospital of Chenzhou City
Chenzhou, Hunan, 423000, China
The Second Affiliated Hospital of South China University
Hengyang, Hunan, 421001, China
The First Affiliated Hospital Of University Of South China
Hengyang, Hunan, China
Huai 'an First People's Hospital
Huaian, Jiangsu, 223300, China
The First People's Hospital of Lianyungang
Lianyungang, Jiangsu, 222061, China
Zhongda Hospital of Southeast University
Nanjing, Jiangsu, 210000, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Affiliated Hospital of Yangzhou University(Yangzhou First People's Hospital)
Yangzhou, Jiangsu, 225003, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212013, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Pingxiang People's Hospital
Pingxiang, Jiangxi, 337099, China
The Second Hospital of Jilin University
Changchun, Jinlin, 130022, China
The First Hospital of Jilin University
Changchun, Jinlin, 130031, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110134, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004, China
Affiliated Hospital of Binzhou Medical University
Binzhou, Shandong, 256600, China
Jinan Central Hospital
Ji'nan, Shandong, 250013, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000, China
Zigong Fourth People's Hospital
Zigong, Sichuan, 643000, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325027, China
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050, China
Peking University Third Hospital
Beijing, 100091, China
Beijing Luhe Hospital Capital Medical University
Beijing, 101100, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
Chongqing University Three Gorges Hospital
Chongqing, 404000, China
Tongji Hospital Affiliated to Tongji University
Shanghai, 200065, China
Shanghai East Hospital
Shanghai, 200120, China
Nankai Hospital of Tianjin City
Tianjin, 300100, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pingsheng Hu, Ph.D
Jiangsu Sinorda Biomedicine Co., Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This trial uses a double-blind double-dummy design, where the investigator, the subject and the other parties involved in the trial are blinded to the drug given to the subject. X842 capsules (test group)and and placebo, lansoprazole enteric-coated capsules (control group)and placebo, are provided by Jiangsu Sinorda Biomedicine Co., Ltd. The physical appearance, shape, specification and dosage of the test drug and comparator as well as the placebo are generally similar.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 14, 2025
First Posted
July 23, 2025
Study Start
June 24, 2021
Primary Completion
July 27, 2022
Study Completion
December 1, 2022
Last Updated
July 23, 2025
Record last verified: 2025-07