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

NCT04531475 | Completed Phase 2

• 1 other identifier: SND-X842-201
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 16

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.

Conditions

Reflux Esophagitis

Keywords

X842; Reflux Esophagitis; GERD; PCAB

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 4 of Treatment

  Subjects cured of RE are defined as subjects who are endoscopically confirmed to be cured of RE.

  4 weeks

Secondary Outcomes (11)

• Proportion of Subjects Whose Reflux Esophagitis LA Grade is Decreased by ≥1 as Confirmed by Endoscopy at Week 4 of Treatment

  4 weeks

• Changes in Gerd-Q Score at Week 2 and 4 Compared With the Baseline

  Week 2 and Week 4

• Changes in Serum Gastrin at Week 2 and 4 of Treatment Compared with the Baseline

  Week 2 and Week 4

• Measurement of the PK Profile

  Week 2 and Week 4

• Number of Subjects Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE)

  Up to 6 weeks

Study Arms (3)

X842 50 mg QD

EXPERIMENTAL

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

Drug: X842; Drug: Lansoprazole Placebo

X842 100 mg QD

EXPERIMENTAL

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

Drug: X842; Drug: Lansoprazole Placebo

Lansoprazole 30 mg QD

EXPERIMENTAL

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

Drug: X842 Placebo; Drug: Lansoprazole

Interventions

X842 DRUG

X842 capsules

Also known as: Undecided

X842 100 mg QD; X842 50 mg QD

X842 Placebo DRUG

X842 placebo-matching capsules

Also known as: Undecided

Lansoprazole 30 mg QD

Lansoprazole DRUG

Lansoprazole capsules

Also known as: Undecided

Lansoprazole 30 mg QD

Lansoprazole Placebo DRUG

Lansoprazole placebo-matching capsules

Also known as: Undecided

X842 100 mg QD; X842 50 mg QD

Eligibility Criteria

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

You may qualify if:

• Males or females, 18 years ≤ age ≤ 75 years;
• 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);
• 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;
• Subjects unable to independently complete the subject diary cards;
• 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)
• Subjects known to have a history of Barrett's esophagus, or who have Barrett's esophagus discovered during endoscopy at screening;
• 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 concomitant cholecystolithiasis, gallbladder wall crystal or gallbladder polyp discovered by B ultrasonography at screening;
• 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);
• 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 proton pump inhibitors (PPIs), P-CABs, histamine2 receptor antagonists (H2RAs), or gastric mucosal protectors (except hydrotalcite) within 2 weeks prior to randomization;
• 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;

Sponsors & Collaborators

• Jiangsu Sinorda Biomedicine Co., Ltd: lead

Study Sites (16)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233004, China

Location

Liuan People's Hospital

Liu‘an, Anhui, 237016, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

The Affiliated Hospital of Guzihou Medical University

Guiyang, Guizhou, 550004, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563000, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

Affiliated Hospital of Xiangnan University

Chenzhou, Hunan, 423000, China

Location

The First people's Hospital of Changzhou

Changzhou, Jiangsu, 213003, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

Jiangxi PingXiang People's Hospital

Pingxiang, Jiangxi, 337000, China

Location

Binzhou Medical University Hospital

Binzhou, Shandong, 256600, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, 250065, China

Location

The Second Affiliated Hospital of Chongqi Medical University

Chongqing, Sichuan, 400010, China

Location

Taizhou Municipal Hospital

Taizhou, Zhejiang, 318000, China

Location

Beijing Luhe Hospital Capital Medical University

Beijing, 101100, China

Location

Related Publications (1)

• 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.

  PMID: 39836012 DERIVED

MeSH Terms

Conditions

Esophagitis, Peptic; Gastroesophageal Reflux

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Pingsheng Hu, Ph.D

  Jiangsu Sinorda Biomedicine Co., Ltd

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This trial uses a double-blind double-dummy design, where both the investigator and the subject are blinded to the drug given to the subject. X842 capsules (test group), lansoprazole enteric-coated capsules (control group), and placebo are provided by the sponsor. The physical appearance, shape, specification and dosage of the test drug and comparator as well as the placebo are generally similar.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: After completing the relevant laboratory tests and endoscopic examinations at screening, subjects who meet the inclusion criteria and do not meet the exclusion criteria are randomly assigned to X842 capsule low-dose group, X842 capsule high-dose group, and lansoprazole enteric-coated capsule group for 4-week treatment and then receive endoscopy. In the study, the duration of subjects receiving treatment with the test drug or comparator is 4 weeks. If a subject has the reflux esophagitis (RE) uncured under endoscopy at week 4 of treatment, the sponsor will give the subject lansoprazole enteric-coated capsules for free for another 4 weeks' treatment.

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 28, 2020
• Study Start: January 21, 2020
• Primary Completion: October 24, 2020
• Study Completion: January 12, 2021
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)