The purpose of this study is to evaluate the efficacy of the study drug (Ilaprazole Sodium for Injection) for potential effect on preventing stress ulcer bleeding in vulnerable population by comparing the radio of upper gastrointestinal bleeding when they are administered Ilaprazole Sodium for Injection and Esomeprazole Sodium for Injection respectively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
449
40 mg i.v. twice daily (q12h)
10 mg i.v. once daily, 20 mg i.v. in the first day.
Physiologic saline for injection, 100 ml/bag, q24h, following Ilaprazole Sodium with a time interval of 12 h.
Physiologic saline for injection, 100 ml/bag, q12h, dosing on the first day.
Shanghai Jiaotong University Affiliate Ruijin Hospital
Shanghai, Shanghai Municipality, China
The First Affiliated Hopspital of Xinjiang Medical University
Ürümqi, Xinjiang, China
Preventing clinically significant gastrointestinal bleeding
(1) Bright red blood is observed in gastric tube and not cleared by gavage washing with at least 100mL of standard physiological saline at room temperature for 5 to 10 minutes;
Time frame: Day 1 to Day 3
Preventing clinically significant gastrointestinal bleeding
(2) During the Day 1 to Day 2 days of the treatment: If coffee-like substances are observed in the gastric tube, immediately rinse the stomach with at least 100ml of standard physiological saline at room temperature, every 2 hours (± 20 minutes) from the time of first observation, and the coffee-like substances were still observed after 8 hours (the occult blood screening reagent remains positive, and the occult blood result is required to be positive);
Time frame: Day 1 and Day 2
Preventing clinically significant gastrointestinal bleeding
(3) On the Day 3 of the treatment - end of treatment: If coffee-like substances are observed in the gastric tube, immediately rinse the stomach with at least 100ml of standard physiological saline at room temperature, once per hour (± 20 minutes), and the coffee-like substances are still observed after 4 hours (occult blood screening reagent continues to be positive, and occult blood results are required to be positive).
Time frame: Day 3
Preventing clinically significant gastrointestinal bleeding
(4) Hematemesis or bloody stools originating from the upper gastrointestinal tract (as determined by the researchers, such as tarry stools and positive gastric occult blood).
Time frame: Day 1 to Day 3
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