A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Phase III Clinical Study to Evaluate the Efficacy and Safety of X842 Capsules in Patients With Reflux Esophagitis
Abstract
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.
Conditions: Reflux Esophagitis.
Primary outcome: Proportion of Subjects Whose Reflux Esophagitis is Cured as Confirmed by Endoscopy at Week 8.
Enrollment: 380 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 380 participants or records.
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