[Translation] Multicenter, randomized, blinded, active-drug parallel controlled phase II clinical study to evaluate H009 injection with different dosage regimens in the treatment of acute gastric and/or duodenal ulcer-induced upper gastrointestinal bleeding after endoscopic treatment to reduce relapse Efficacy and Safety in Bleeding Risk
主要目的:与注射用艾司奥美拉唑钠(Esomeprazole,ESO)相比,对急性胃和/或十二指肠溃疡引起的上消化道出血且再出血风险为高危者经内镜下治疗后给予不同剂量给药方案的H009注射液以评价降低再出血风险的有效性;
次要目的:与注射用ESO相比,对急性胃和/或十二指肠溃疡引起的上消化道出血且再出血风险为高危者经内镜下治疗后给予不同剂量给药方案的H009注射液以评价对再出血相关事件的影响;与注射用ESO相比,观察不同剂量给药方案的H009注射液用于急性胃和/或十二指肠溃疡引起的上消化道出血的安全性;观察H009注射液在消化性溃疡出血人群中的群体药代动力学特征。
[Translation] Main purpose: Compared with Esomeprazole sodium (ESO) for injection, endoscopic treatment of upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcer and high risk of rebleeding Afterwards, H009 injection with different dosage regimens was given to evaluate the effectiveness of reducing the risk of rebleeding;
Secondary objective: Compared with ESO for injection, H009 injection with different dosage regimens after endoscopic treatment in patients with upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcer and high risk of rebleeding To evaluate the effect on rebleeding-related events; to observe the safety of H009 injection with different dosage regimens for upper gastrointestinal bleeding caused by acute gastric and/or duodenal ulcer compared with ESO for injection; To observe the population pharmacokinetic characteristics of H009 injection in peptic ulcer bleeding population.