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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
380
X842 capsules
X842 placebo-matching capsules
Lansoprazole capsules
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.
Time frame: 8 weeks
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.
Time frame: 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.
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.
Time frame: 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.
Time frame: 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.
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Lansoprazole placebo-matching capsules
Liuan People's Hospital
Liu‘an, Anhui, China
Xuancheng People's Hospital
Xuancheng, Anhui, China
The 900th Hospital of the Joint Logistic Support Force of the People's Liberation Army of China
Fuzhou, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, China
...and 43 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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"
Time frame: 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
Time frame: 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.
Time frame: up to 8 weeks