XuanZhuBio-B (02575) has announced the successful completion of patient enrollment for the Phase III clinical trial in China of its self-developed innovative drug, Anaprazole Sodium Enteric-coated Tablets (brand name: Anjiuwe®), for treating adult reflux esophagitis. The trial has enrolled all 500 planned participants.
This Phase III study is a multicenter, randomized, double-blind, double-dummy, active-controlled pivotal trial designed to evaluate the efficacy and safety of Anaprazole Sodium Enteric-coated Tablets in Chinese adult patients with reflux esophagitis. The primary clinical endpoint is the endoscopic healing rate of reflux esophagitis after a predefined treatment period, comparing results against the active control drug within eight weeks of treatment.
Secondary endpoints include multiple efficacy dimensions such as endoscopic healing rates at week four, changes from baseline in severity and frequency of core symptoms (heartburn and acid reflux) at weeks four and eight. Safety assessments will primarily focus on the types, incidence rates, and severity of adverse events observed during the trial.
Comments