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

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ClinicalTrials.gov Identifier: NCT00247130
Recruitment Status : Withdrawn (Superiority of iv omeprazole to ranitidine has already been proven by others.)
First Posted : November 1, 2005
Last Update Posted : April 3, 2015
Sponsor:
Information provided by (Responsible Party):
Hidekazu Suzuki, M.D., Ph.D., Keio University

Tracking Information
First Submitted Date  ICMJE October 28, 2005
First Posted Date  ICMJE November 1, 2005
Last Update Posted Date April 3, 2015
Study Start Date  ICMJE October 2005
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 31, 2015)
No evidence of hemorrhage or vessel exposure on a second endoscopy [ Time Frame: 4 weeks after the bleeding ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2005)
  • No evidence of hemorrhage or vessel exposure on a second endoscopy
  • No evidence of hemorrhage or vessel exposure on a third endoscopy
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 31, 2015)
  • Plasma ghrelin levels [ Time Frame: 4 weeks after the bleeding ]
  • Serum gastrin levels [ Time Frame: 4 weeks after the bleeding ]
  • No evidence of hemorrhage or vessel exposure on a third endoscopy [ Time Frame: 12 weeks after the bleeding ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2005)
  • Plasma ghrelin levels
  • Serum gastrin levels
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Intravenous Omeprazole to Ranitidine on Recurrent Bleeding After Endoscopic Treatment of Bleeding Ulcer
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Peptic Ulcers
Intervention  ICMJE
  • Drug: Omeprazole
    Other Name: omeprazon
  • Drug: Ranitidine
    Other Name: Zantac
Study Arms  ICMJE
  • Active Comparator: Omeprazole
    Omeprazole (20 mg), intravenous, 2x /day
    Intervention: Drug: Omeprazole
  • Active Comparator: Ranitidine
    Ranitidine (100 mg), intravenous drip infusion, 2x /day.
    Intervention: Drug: Ranitidine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 31, 2015)
0
Original Enrollment  ICMJE
 (submitted: October 31, 2005)
400
Actual Study Completion Date  ICMJE July 2007
Actual Primary Completion Date July 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00247130
Other Study ID Numbers  ICMJE KEIO-UGI-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hidekazu Suzuki, M.D., Ph.D., Keio University
Study Sponsor  ICMJE Keio University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Keio University
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP