Comparison of Intravenous Omeprazole to Ranitidine on Recurrent Bleeding After Endoscopic Treatment of Bleeding Ulcer

• Status: Withdrawn
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The present study will compare the hemostasis-maintaining effects of intravenous omeprazole and ranitidine in patients with upper gastrointestinal hemorrhage that have undergone endoscopic hemostasis, to establish which anti-secretory medication prior to the start of oral alimentation is effective in preventing re-hemorrhage after hemostasis.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Keio University
• Treatments: Omeprazole; Ranitidine; Ranitidine bismuth citrate

Criteria

Inclusion Criteria:

• Patients with identified gastric or duodenal ulcer

• Patients with hemorrhagic exposed vessel at the ulcer lesion, oozing or projectile hemorrhage (predominantly arterial) from the ulcer, and where endoscopic hemostasis has been performed.

• Over 20 years of age of either sex.

• The subject or his or her proxy consenter has provided written informed consent.

Exclusion Criteria:

• Serious hepatopathy, nephropathy, or heart disease.

• Complicating malignant tumor.

• Hemorrhage from malignant tumor.

• The patient is on, or in need of, treatment with a drug considered to interact with the test drug.

• History of allergy to the test drug.

• History of anaphylactic shock.

• Pregnant, possibly pregnant, or lactating.

• patient who is unable to fully understand the explanation about the study.

• patient who is judged by the investigator to be otherwise inappropriate for inclusion.