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Efficacy and safety of lansoprazole for the treatment of gastric ulcer with hemorrhage: a randomized, double-blind, positive drug control, multicenter clinical trial

Efficacy and safety of lansoprazole for the treatment of gastric ulcer with hemorrhage: a randomized, double-blind, positive drug control, multicenter clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018588
Enrollment
Unknown
Registered
2018-09-25
Start date
2018-10-05
Completion date
Unknown
Last updated
2018-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric ulcer with bleeding

Interventions

Group 1:Lansoprazole for injection
Group 2:Omeprazole sodium for injection

Sponsors

Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. aged 18 to 65 years old male and female; 2. Within 48 hours before enrollment, there are symptoms of upper hemorrhagic hemorrhage such as hematemesis and/or melena (positive fecal occult blood), and endoscopically determined to be bleeding caused by gastric ulcer, and it is not suitable for oral administration; 3, a single ulcer diameter = 2cm; 4. Negative pregnancy test; 5. The subject informed and voluntarily signed the informed consent form and agreed to participate in all visits, examinations and treatments as required by the protocol.

Exclusion criteria

Exclusion criteria: 1. hemoglobin normal upper limit); 9. severe cardiac insufficiency (NYHA grade 3 ~ 4), pulmonary insufficiency (symptoms of respiratory failure), malignant tumors, blood and hematopoietic system diseases; 10. combined with Barth syndrome, hypokalemia, hypocalcemia and acid-base balance disorders; 11. Those who have neurological or mental illnesses who are unable to cooperate or are unwilling to cooperate; 12. Suspect or have a history of alcohol or drug abuse, or other circumstances that reduce the likelihood of enrollment or complicate enrollment, according to the investigator's judgment; 13. Pregnant women, breastfeeding women and those with birth plans in the near future; 14. Those who have participated in other clinical trials within 3 months before the trial; 15. The investigator believes that it is not appropriate to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
72-hour hemostasis rate;

Secondary

MeasureTime frame
72-hour rebleeding rate;Need to switch to other treatment rates during the course of treatment;Adverse event rate and incidence of adverse reactions;

Countries

China

Contacts

Public ContactLiu Side

Nanfang Hospital, Southern Medical University

liuside2011@163.com+86 020 61641537

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026