智通财经APP讯，轩竹生物-B(02575)发布公告，公司自主研发的创新药安奈拉唑钠肠溶片(商品名：安久卫®)用于治疗成人反流性食管炎(RE)的中国III期临床试验已于近日顺利完成全部500名受试者入组。
该项III期临床试验是一项多中心、随机、双盲双模拟、阳性药物平行对照的关键性研究，旨在评估安奈拉唑钠肠溶片治疗中国成年反流性食管炎受试者的有效性和安全性。试验的主要临床终点为治疗预设周期后，与阳性对照药相比，内镜下受试者反流性食管炎治愈率(治疗8周内(含8周));次要终点涵盖内镜下受试者反流性食管炎治愈率(治疗第4周)、主要症状(烧心和反流)的严重程度和发生频率较基线的变化(治疗第4周和第8周)等多维疗效指标。安全性指标主要为不良事件的发生类型、发生率、严重程度。
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