The Phase III Clinical Trial of X842 Capsules for Reflux Esophagitis (NCT07079540) | Clinical Trial Compass
CompletedPhase 3
The Phase III Clinical Trial of X842 Capsules for Reflux Esophagitis
China380 participantsStarted 2021-06-24
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Males or females, 18 years ≤ age ≤ 75 years;
✓. Within 7 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 20% of the all subjects who are planned to be enrolled in the study);
✓. Subjects who can independently complete the subject diary cards;
✓. 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;
✕. Endoscopic examination revealed concomitant diseases potentially affecting the esophagus, excluding hiatal hernia, and excluding Barrett's esophagus with metaplastic columnar epithelium that either does not involve the entire esophageal circumference or is short-segment (\< 3 cm in length).
✕. Patients with rheumatic/autoimmune diseases potentially affecting esophageal motility (e.g., scleroderma, undifferentiated connective tissue disease), or those with a history of esophageal radiotherapy or cryotherapy;
What they're measuring
1
Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 8