- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04531475
Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis
August 26, 2020 updated by: Jiangsu Sinorda Biomedicine Co., Ltd
A Multicenter, Randomized, Double-blind, Double-simulation, Active Comparator-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of X842 Capsules at Different Dosages in Patients With Reflux Esophagitis
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ming Lu
- Phone Number: +8618684676235
- Email: lum@sinorda.com
Study Locations
-
-
Anhui
-
Bengbu, Anhui, China, 233004
- Recruiting
- The First Affiliated Hospital of Bengbu Medical College
-
Contact:
- Qizhi Wang
-
Liu'an, Anhui, China, 237016
- Recruiting
- Liuan People's Hospital
-
Contact:
- Haitao Tang
-
-
Beijing
-
Beijing, Beijing, China, 101100
- Recruiting
- Beijing Luhe Hospital Capital Medical University
-
Contact:
- Baohong Xu
-
Beijing, Beijing, China, 100050
- Recruiting
- Beijing Friendship Hospital, Capital Medical University
-
Contact:
- Shutian Zhang, MD, Ph.D
-
-
Guizhou
-
Guiyang, Guizhou, China, 550004
- Recruiting
- The Affiliated Hospital of Guzihou Medical University
-
Contact:
- Qi Liu
-
Zunyi, Guizhou, China, 563000
- Recruiting
- Affiliated Hospital of Zunyi Medical University
-
Contact:
- Biguang Tuo
-
-
Hunan
-
Changsha, Hunan, China, 410008
- Recruiting
- Xiangya Hospital Central South University
-
Contact:
- Xiaowei Liu
-
Chenzhou, Hunan, China, 423000
- Recruiting
- Affiliated Hospital of Xiangnan University
-
Contact:
- Jiuye Hu
-
-
Jiangsu
-
Changzhou, Jiangsu, China, 213003
- Recruiting
- The First People's Hospital Of Changzhou
-
Contact:
- Dong Shao
-
Nanjing, Jiangsu, China, 210006
- Recruiting
- Nanjing First Hospital
-
Contact:
- Zhenyu Zhang
-
-
Jiangxi
-
Pingxiang, Jiangxi, China, 337000
- Recruiting
- Jiangxi Pingxiang People's Hospital
-
Contact:
- Xing Li
-
-
Shandong
-
Binzhou, Shandong, China, 256600
- Recruiting
- Binzhou Medical University Hospital
-
Contact:
- Chengxia Liu
-
Jinan, Shandong, China, 250013
- Recruiting
- Jinan Central Hospital
-
Contact:
- Yanbo Zhen
-
-
Shanghai
-
Shanghai, Shanghai, China, 250065
- Recruiting
- Tongji Hospital of Tongji University
-
Contact:
- Shenglan Wang
-
-
Sichuan
-
Chongqing, Sichuan, China, 400010
- Recruiting
- The Second Affiliated Hospital of Chongqi Medical University
-
Contact:
- Song He
-
-
Zhejiang
-
Taizhou, Zhejiang, China, 318000
- Recruiting
- Taizhou Municipal hospital
-
Contact:
- Yangde Miu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion criteria:
- 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;
- Laboratory test results at screening showing that ALT or AST is larger than 1.5 times of the upper limit of normal, or kidney function index Cr is larger than the upper limit of normal (a re-examination is permitted in the study, and subjects will be excluded if they still fail to meet the inclusion criteria);
- 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;
- At screening, subjects with clinically significant ECG abnormalities, including serious arrhythmia, multifocal preventricular contraction (PVC), grade II or above atrioventricular block, and prolongation of the Q-T interval (QTc≥450 ms in males and QTc≥470 ms in females);
- Diabetic subjects with poorly controlled blood glucose level (fasting blood glucose (FBG) > 10.0 mmol/L), or hypertensive subjects with poorly controlled blood pressure (systolic pressure ≥150 mmHg or diastolic pressure ≥100 mmHg);
- Subjects with known acquired immunodeficiency syndrome (AIDS);
- Subjects who are using atazanavir sulfate or ripivirin hydrochloride at screening;
- Subjects with a history of long-term abuse of drug or alcohol within 6 months prior to screening;
- Female subjects with suspicious or 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;
- Subject who plan to have a surgery requiring hospitalization, or subject who need to have a surgery during his/her participation in the study;
- Subjects who participate in other drug/medical device clinical studies and use the drug/medical device within 3 months prior to randomization;
- Subjects who are considered unsuitable for participating in this trial by investigators.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: X842 50 mg QD
X842 50 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 weeks.
|
Lansoprazole placebo-matching capsules
Other Names:
X842 capsules
Other Names:
|
Experimental: X842 100 mg QD
X842 100 mg, capsule, orally, once daily and lansoprazole placebo-matching capsule, orally, once daily up to 4 weeks.
|
Lansoprazole placebo-matching capsules
Other Names:
X842 capsules
Other Names:
|
Experimental: Lansoprazole 30 mg QD
Lansoprazole 30 mg, capsule, orally, once daily and X842 placebo-matching capsule, orally, once daily up to 4 weeks.
|
Lansoprazole capsules
Other Names:
X842 placebo-matching capsules
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 4 of Treatment
Time Frame: 4 weeks
|
Subjects cured of RE are defined as subjects who are endoscopically confirmed to be cured of RE.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
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
Time Frame: 4 weeks
|
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
Time Frame: Week 2 and Week 4
|
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
Time Frame: Week 2 and Week 4
|
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
Time Frame: Week 2 and Week 4
|
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)
Time Frame: Up to 6 weeks
|
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
Time Frame: Up to 6 weeks
|
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
Time Frame: Up to 6 weeks
|
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
Time Frame: Up to 6 weeks
|
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
Time Frame: Up to 6 weeks
|
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
Time Frame: Up to 6 weeks
|
°C = degrees Celsius
|
Up to 6 weeks
|
Vital signs of blood pressure
Time Frame: Up to 6 weeks
|
Blood pressure measurements included systolic (mmHg) and diastolic (mmHg).
|
Up to 6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Pingsheng Hu, Ph.D, Jiangsu Sinorda Biomedicine Co., Ltd
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 22, 2019
Primary Completion (Anticipated)
October 31, 2020
Study Completion (Anticipated)
December 31, 2020
Study Registration Dates
First Submitted
August 26, 2020
First Submitted That Met QC Criteria
August 26, 2020
First Posted (Actual)
August 28, 2020
Study Record Updates
Last Update Posted (Actual)
August 28, 2020
Last Update Submitted That Met QC Criteria
August 26, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Esophageal Motility Disorders
- Deglutition Disorders
- Esophageal Diseases
- Peptic Ulcer
- Duodenal Diseases
- Gastroesophageal Reflux
- Esophagitis, Peptic
- Esophagitis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Dexlansoprazole
- Lansoprazole
Other Study ID Numbers
- SND-X842-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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