Upper gastrointestinal bleeding due to acute gastric and/or duodenal ulcers
Conditions
Interventions
Experimental group:Esomeprazole sodium for injection
Experimental group:LX22001 for injection Group 2
Control group:Esomeprazole sodium for injection
Sponsors
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Male or female >= age 18 years old and <= 70 years old. 2) Symptoms of upper gastrointestinal bleeding, such as hematemesis, black stool, or other possible clinical manifestations, occurred 48 hours before screening; 3) Upper gastrointestinal bleeding due to acute gastric and/or duodenal ulcers confirmed by endoscopy within 24 hours before randomization, with larger ulcers ranging in maximum diameter from 5 to 20mm. 4) The Forrest classification of peptic ulcers is ?a, ?b, ?a, ?b. Multiple ulcers are determined by those with high Forrest level, and successful hemostasis after endoscopic treatment is confirmed. The specific requirements for endoscopic treatment are as follows: For Forrest Ia, Ib, ?a: thermal coagulation, condensation hemostasis and/or mechanical hemostasis are used as the main means. It is also permitted to combine local epinephrine drug injection on the basis of the above-mentioned main means; Patients with Forrest IIb: To confirm the specific classification, endoscopic irrigation should be attempted first to remove the attached blood clot. If the blood clot is cleared, the Forrest classification is evaluated again. In the case of Forrest Ia, Ib, ?a, endoscopic hemostasis is performed according to the above requirements. If the blood clot is not cleared, that is, Forrest IIb is finally confirmed, and endoscopic hemostasis therapy can be performed according to the judgment of the investigator or the patient can be directly enrolled. 5) Consent to the use of appropriate medical methods for contraception (except in the case of medical sterilization) for at least 3 months from the signing of the informed consent to the last medication: a) Medical sterilization status is defined as post-menopause (natural menopause for at least 12 months), post-hysterectomy, post-bilateral salpingectomy and post-bilateral oophorectomy; b) Appropriate medical methods of contraception include Iuds, physical barriers (male condoms, female condoms), subcutaneous implants, sustained release injectable contraceptives, oral contraceptives, bilateral tubal ligation and bilateral vasectomy. Dual contraception is recommended to ensure that no pregnancy occurs during the study. 6)Fully understand the content of the experiment, voluntarily participate in the experiment, and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1) Hemorrhagic shock or systolic blood pressure 1.5 times upper limit of normal (ULN)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of no rebleeding within 72h after initiation of medication (Endoscopic evaluation); | — |
Countries
China
Contacts
Public ContactDuowu Zou
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed