[Translation] Efficacy and safety of analazole sodium enteric-coated tablets in the treatment of reflux esophagitis: a multicenter, randomized, double-blind, double-dummy, active drug parallel controlled phase II clinical trial
主要目的是评价安纳拉唑钠肠溶片治疗反流性食管炎的有效性。次要目的是评价安纳拉唑钠肠溶片对反流性食管炎患者的症状控制和生活质量改善的有效性;评价安纳拉唑钠肠溶片治疗反流性食管炎的安全性;评价安纳拉唑钠肠溶片口服给药在反流性食管炎受试者中的群体药代动力学。探索性目的是探索药物代谢酶的基因多态性对药物暴露量和/或疗效的影响。
[Translation] The main objective was to evaluate the efficacy of analazole sodium enteric-coated tablets in the treatment of reflux esophagitis. The secondary objective was to evaluate the efficacy of Analazole Sodium Enteric-Coated Tablets on symptom control and improvement of quality of life in patients with reflux esophagitis; to evaluate the safety of Analazole Sodium Enteric-Coated Tablets in the treatment of reflux esophagitis; To evaluate the population pharmacokinetics of oral administration of analazole sodium enteric-coated tablets in subjects with reflux esophagitis. The exploratory objective was to explore the effect of genetic polymorphisms of drug-metabolizing enzymes on drug exposure and/or efficacy.