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

NCT00247130 | Withdrawn Phase 4

• 1 other identifier: KEIO-UGI-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peptic Ulcers

Keywords

Omeprazole; Ranitidine; Endoscopic treatment; Hemostasis; Peptic ulcer

Outcome Measures

Primary Outcomes (1)

• No evidence of hemorrhage or vessel exposure on a second endoscopy

  4 weeks after the bleeding

Secondary Outcomes (3)

• Plasma ghrelin levels

  4 weeks after the bleeding

• Serum gastrin levels

  4 weeks after the bleeding

• No evidence of hemorrhage or vessel exposure on a third endoscopy

  12 weeks after the bleeding

Study Arms (2)

Omeprazole

ACTIVE COMPARATOR

Omeprazole (20 mg), intravenous, 2x /day

Drug: Omeprazole

Ranitidine

ACTIVE COMPARATOR

Ranitidine (100 mg), intravenous drip infusion, 2x /day.

Drug: Ranitidine

Interventions

Omeprazole DRUG

Also known as: omeprazon

Omeprazole

Ranitidine DRUG

Also known as: Zantac

Ranitidine

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keio University: lead

Study Sites (1)

Department of Internal Medicine, Keio University School of Medicine

Tokyo, Tokyo, 1608582, Japan

Location

MeSH Terms

Conditions

Peptic Ulcer

Interventions

Omeprazole; Ranitidine

Condition Hierarchy (Ancestors)

Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Furans

Study Officials

• Toshifumi Hibi, M.D., Ph.D.

  Division of Gastroenterology, Department of Internal Medicine, Keio University School of Medicine

  STUDY CHAIR

• Hidekazu Suzuki, M.D., Ph.D.

  Upper GI Research Center, Keio University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 28, 2005
• First Posted: November 1, 2005
• Study Start: October 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: April 3, 2015

Record last verified: 2015-03

Locations

JP (1)