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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
90
X842 capsules
X842 placebo-matching capsules
Lansoprazole capsules
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Liuan People's Hospital
Liu‘an, Anhui, China
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
Changes in Gerd-Q Score at Week 2 and 4 Compared With the Baseline
Subjects must record RE symptoms that occur within 7d prior to each visit in the Gerd-Q under the guidance of the investigator.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Lansoprazole placebo-matching capsules
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The Affiliated Hospital of Guzihou Medical University
Guiyang, Guizhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Affiliated Hospital of Xiangnan University
Chenzhou, Hunan, China
The First people's Hospital of Changzhou
Changzhou, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
Jiangxi PingXiang People's Hospital
Pingxiang, Jiangxi, China
...and 6 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: Up to 6 weeks
Vital signs of body temperature
°C = degrees Celsius
Time frame: Up to 6 weeks
Vital signs of blood pressure
Blood pressure measurements included systolic (mmHg) and diastolic (mmHg).
Time frame: Up to 6 weeks