Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X842 50 mg QD | Experimental | X842 50 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 weeks. |
|
| X842 100 mg QD | Experimental | X842 100 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 weeks. |
|
| Lansoprazole 30 mg QD | Experimental | Lansoprazole 30 mg, capsule, orally, once daily and X842 placebo-matching capsule, orally, once daily up to 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X842 | Drug | X842 capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Whose Reflux Esophagitis LA Grade is Decreased by ≥1 as Confirmed by Endoscopy at Week 4 of Treatment | The endoscopic results must describe RE severity according to the LA grading criteria. | 4 weeks |
| Changes in Gerd-Q Score at Week 2 and 4 Compared With the Baseline |
Not provided
Inclusion Criteria:
Exclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pingsheng Hu, Ph.D | Jiangsu Sinorda Biomedicine Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | 233004 | China | ||
| Liuan People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39836012 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
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.
| X842 Placebo | Drug | X842 placebo-matching capsules |
|
|
| Lansoprazole | Drug | Lansoprazole capsules |
|
|
| Lansoprazole Placebo | Drug | Lansoprazole placebo-matching capsules |
|
|
Subjects must record RE symptoms that occur within 7d prior to each visit in the Gerd-Q under the guidance of the investigator. |
| Week 2 and Week 4 |
| Changes in Serum Gastrin at Week 2 and 4 of Treatment Compared with the Baseline | Serum gastrin testing will be conducted at the central laboratory. The change between the serum gastrin values collected at Weeks 2 and 4 relative to baseline. | Week 2 and Week 4 |
| Measurement of the PK Profile | Plasma concentrations of X842 and its metabolites are measured to determine X842 exposure in patients. | Week 2 and Week 4 |
| Number of Subjects Reporting Who Had One or More Treatment-emergent Adverse Event (TEAE) | Adverse event is defined as any adverse medical event that is observed in a subject who is receiving a drug treatment or in a clinical study, and that does not necessarily have a causal relationship with the treatment. | Up to 6 weeks |
| Number of Subjects With Markedly Abnormal Clinical Laboratory assessment of blood serum | Number of subjects with any markedly abnormal values in laboratory tests of blood serum collected throughout study is reported. | Up to 6 weeks |
| Number of Subjects With Markedly Abnormal Clinical Laboratory assessment of blood | Number of subjects with any markedly abnormal values in laboratory tests of blood collected throughout study is reported. | Up to 6 weeks |
| Number of Subjects With Markedly Abnormal Clinical Laboratory assessment of urine | Number of subjects with any markedly abnormal values in laboratory tests of urine collected throughout study is reported.collected throughout study is reported. | Up to 6 weeks |
| Number of Subjects With Markedly Abnormal Electrocardiogram (ECG) Findings | The investigator or the sub-investigator interpreted the ECG using one of the following categories: "within normal limits", "abnormal but not clinically significant", or "abnormal and clinically significant". | Up to 6 weeks |
| Vital signs of body temperature | °C = degrees Celsius | Up to 6 weeks |
| Vital signs of blood pressure | Blood pressure measurements included systolic (mmHg) and diastolic (mmHg). | Up to 6 weeks |
| Liu‘an |
| Anhui |
| 237016 |
| China |
| Beijing Friendship Hospital, Capital Medical University | Beijing | Beijing Municipality | 100050 | China |
| The Affiliated Hospital of Guzihou Medical University | Guiyang | Guizhou | 550004 | China |
| Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | 563000 | China |
| Xiangya Hospital Central South University | Changsha | Hunan | 410008 | China |
| Affiliated Hospital of Xiangnan University | Chenzhou | Hunan | 423000 | China |
| The First people's Hospital of Changzhou | Changzhou | Jiangsu | 213003 | China |
| Nanjing First Hospital | Nanjing | Jiangsu | 210006 | China |
| Jiangxi PingXiang People's Hospital | Pingxiang | Jiangxi | 337000 | China |
| Binzhou Medical University Hospital | Binzhou | Shandong | 256600 | China |
| Jinan Central Hospital | Jinan | Shandong | 250013 | China |
| Tongji Hospital of Tongji University | Shanghai | Shanghai Municipality | 250065 | China |
| The Second Affiliated Hospital of Chongqi Medical University | Chongqing | Sichuan | 400010 | China |
| Taizhou Municipal Hospital | Taizhou | Zhejiang | 318000 | China |
| Beijing Luhe Hospital Capital Medical University | Beijing | 101100 | China |
| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided