Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis (NCT04531475) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis
China90 participantsStarted 2020-01-21
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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;
What they're measuring
1
Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 4 of Treatment