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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR20210736 | Other Identifier | ChiCTR |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X842 50mg QD | Experimental | X842 50 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 to 8 weeks. |
|
| lansoprazole 30mg QD | Active Comparator | 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 8 | Healing of reflux esophagitis is defined as endoscopic confirmation of resolved esophagitis (absence of esophageal mucosal breaks) in subjects. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 4 | Healing of reflux esophagitis is defined as endoscopic confirmation of resolved esophagitis (absence of esophageal mucosal breaks) in subjects. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pingsheng Hu, Ph.D | Jiangsu Sinorda Biomedicine Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liuan People's Hospital | Liu‘an | Anhui | 237016 | China | ||
| Xuancheng People's Hospital |
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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 under blinding at a 3:1 ratio assigned to test group(X842 Capsule)and control group ( Lansoprazole enteric-coated Capsules) for for 4-week treatment and then receive endoscopy. If endoscopy shows healed esophagitis, treatment will be discontinued; if esophagitis remains unhealed, treatment continues for an additional 4 weeks. The minimum treatment duration with either test or control drug is 4 weeks, and the maximum is 8 weeks in this study.
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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.
| X842 Placebo |
| Drug |
X842 placebo-matching capsules |
|
| Lansoprazole | Drug | Lansoprazole capsules |
|
|
| Lansoprazole Placebo | Drug | Lansoprazole placebo-matching capsules |
|
Improvement in the frequency of clinical symptom occurrence: Defined as subjects whose symptom frequency score before treatment was ≥1 point had a reduction of ≥1 point after treatment compared to before treatment. Improvement in the severity of clinical symptoms: Defined as a reduction of ≥1 point in the symptom severity score of subjects with a score of ≥1 point before treatment after treatment compared to before treatment. |
| 2,4,8 weeks |
| Response rates for individual symptom domains (heartburn, regurgitation) in reflux esophagitis at Weeks 2, 4, and 8 post-baseline. | Resolution of individual clinical symptoms: defined as the achievement of score 0 in both severity and frequency for symptoms with baseline scores ≥1. | 2.4.8 weeks |
| Overall symptomatic resolution rate for reflux esophagitis at Weeks 2, 4, and 8 | Overall Clinical Symptom Resolution: Defined as the achievement of a score of 0 (i.e., complete disappearance) for all symptoms of reflux esophagitis in subjects with any individual symptom score ≥1 at baseline. | 2,4,8 weeks |
| Change in serum gastrin levels from baseline at Weeks 4 and 8 of treatment | Serum gastrin testing will be conducted at the central laboratory. The change between the serum gastrin values collected at Weeks 4 and 8 relative to baseline. | 4, 8 weeks |
| 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 8 weeks |
| Number of Subjects With Markedly Abnormal Clinical Laboratory assessment of blood serum 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 8 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 8 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 8 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 8 weeks |
| Vital signs | Blood pressure, respiration, heart rate and body temperature were evaluated at each visit during the screening period and the double-blind treatment period | up to 8 weeks |
| Pharmacokinetic evaluation | Quantification of plasma concentrations of X842 and its metabolites to characterize the population pharmacokinetic profile of X842 capsules in GERD patients. | up to 8 weeks |
| 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 | Liuzhou | 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 |
| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| 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 |
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| 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 |
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