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

This study has been withdrawn prior to enrollment.
(Superiority of iv omeprazole to ranitidine has already been proven by others.)
Sponsor:
Information provided by (Responsible Party):
Hidekazu Suzuki, M.D., Ph.D., Keio University
ClinicalTrials.gov Identifier:
NCT00247130
First received: October 28, 2005
Last updated: March 31, 2015
Last verified: March 2015
  Purpose
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.

Condition Intervention Phase
Peptic Ulcers
Drug: Omeprazole
Drug: Ranitidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: A Prospective, Randomized Trial Comparing the Effect of Intravenous Omeprazole to That of Intravenous Ranitidine on the Maintenance of Hemostasis After Successful Endoscopic Treatment of Bleeding Peptic Ulcer

Resource links provided by NLM:


Further study details as provided by Keio University:

Primary Outcome Measures:
  • No evidence of hemorrhage or vessel exposure on a second endoscopy [ Time Frame: 4 weeks after the bleeding ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma ghrelin levels [ Time Frame: 4 weeks after the bleeding ] [ Designated as safety issue: No ]
  • Serum gastrin levels [ Time Frame: 4 weeks after the bleeding ] [ Designated as safety issue: No ]
  • No evidence of hemorrhage or vessel exposure on a third endoscopy [ Time Frame: 12 weeks after the bleeding ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: October 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Omeprazole
Omeprazole (20 mg), intravenous, 2x /day
Drug: Omeprazole
Other Name: omeprazon
Active Comparator: Ranitidine
Ranitidine (100 mg), intravenous drip infusion, 2x /day.
Drug: Ranitidine
Other Name: Zantac

Detailed Description:
Gastrointestinal hemorrhage is a relatively common condition, with the source of the bleeding being most commonly from the upper gastrointestinal tract, especially from gastric and duodenal ulcers. It often requires emergency treatment. First, the site of bleeding is determined. If an exposed blood vessel is found in the hemorrhagic lesion, or in the case of oozing or projectile hemorrhage, endoscopic hemostasis is performed on the lesion. After hemostasis is achieved, prevention of re-bleeding is important; usually, an antacid or similar medication is administered and the course is monitored under fasting conditions.Suppression of gastric acid secretion is necessary to raise gastric pH levels and maintain normal blood coagulation, and to promote healing of hemorrhagic lesions. In Japan, intravenous preparations of H2 receptor antagonists and proton pump inhibitors have been commonly used.In foreign countries, drug therapy for patients with upper gastrointestinal hemorrhage emphasizes the maintenance of normal blood coagulation. High doses of these drugs have been established to constantly maintain a pH of 7 in the stomach (Daneshmend TK, et al., BMJ 1992, 304:143-147; Labentz J, et al., Gut 1997, 40:36-41; Hasselgren G, et al., Scand J Gastroenterol 1997, 32:328-333; Schaffalitzky de Muckadell OB, et al., Scand J Gastroenterol 1997, 32:320-327; Sung JJY, et al., Ann Intern Med 2003, 139:237-243). In a clinical study, proton pump inhibitors were superior to H2 receptor antagonists in terms of clinical efficacy (Labentz J, et al., Gut 1997, 40:36-41). In Japan, emphasis is placed on promoting healing of lesions since endoscopic hemostasis is a fairly common practice; doses have been established at levels similar to therapeutic doses for peptic ulcers. It cannot be said, however, that superiority of intravenous proton pump inhibitors over H2 receptor antagonists has been established at such doses. This can possibly be attributed to fact that in previous studies the study populations were not homogenous in terms of severity; for example, patients requiring endoscopic hemostasis and those that did not were both included.Against this background, this 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.
  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247130

Locations
Japan
Department of Internal Medicine, Keio University School of Medicine
Tokyo, Japan, 1608582
Sponsors and Collaborators
Keio University
Investigators
Study Chair: Toshifumi Hibi, M.D., Ph.D. Division of Gastroenterology, Department of Internal Medicine, Keio University School of Medicine
Principal Investigator: Hidekazu Suzuki, M.D., Ph.D. Upper GI Research Center, Keio University School of Medicine
  More Information

Responsible Party: Hidekazu Suzuki, M.D., Ph.D., Associate Professor, Keio University
ClinicalTrials.gov Identifier: NCT00247130     History of Changes
Other Study ID Numbers: KEIO-UGI-001 
Study First Received: October 28, 2005
Last Updated: March 31, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Keio University:
Omeprazole
Ranitidine
Endoscopic treatment
Hemostasis
Peptic ulcer

Additional relevant MeSH terms:
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Omeprazole
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 24, 2016