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Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers

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ClinicalTrials.gov Identifier: NCT00279123
Recruitment Status : Completed
First Posted : January 19, 2006
Last Update Posted : January 19, 2006
Sponsor:
Information provided by:
Kwong Wah Hospital

Brief Summary:

Endoscopic treatment of bleeding peptic ulcers is effective to prevent rebleeding. Adjuvant medical treatment to increase gastric pH may further decrease rebleeding. Recent studies on potent acid suppression by proton pump inhibitors (PPI) demonstrated the efficacy in preventing rebleeding. Lau demonstrated that high dose intravenous infusion of omeprazole decreased rebleeding in peptic ulcers with stigmata of recent hemorrhage.

There is little data regarding the effect of pantoprazole on bleeding peptic ulcers. Furthermore, the optimal dose of PPI is unknown. Few studies have included measurement of gastric pH in addition to clinical outcome.

This study compares the effect of two doses of intravenous pantoprazole with no acid suppression in bleeding peptic ulcers after endoscopic therapy. In addition to the usual clinical endpoints, gastric pH is monitored to study the relation of pH elevation and the clinical outcome.


Condition or disease Intervention/treatment Phase
Peptic Ulcer Hemorrhage Drug: pantoprazole infusion Drug: pantoprazole bolus Drug: no treatment Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2002

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U.S. FDA Resources




Primary Outcome Measures :
  1. Rebleeding rate within 30 days after endoscopic therapy

Secondary Outcome Measures :
  1. Transfusion requirement
  2. duration of hospital stay
  3. need for operative intervention
  4. mortality rate
  5. gastric pH
  6. side effects of pantoprazole


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • patients presenting with upper gastrointestinal bleeding with upper endoscopy showing a bleeding peptic ulcer with major stigmata of haemorrhage and after successful endoscopic haemostasis.

Exclusion Criteria:

  • previous gastrectomy and vagotomy
  • patient taking warfarin
  • intake of anti-secretory drugs in the previous 48 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00279123


Locations
China
Department of Surgery, Kwong Wah Hospital
Hong Kong, China
Sponsors and Collaborators
Kwong Wah Hospital
Investigators
Principal Investigator: Wai-ka Hung, MBBS Department of Surgery, Kowng Wah Hospital

ClinicalTrials.gov Identifier: NCT00279123     History of Changes
Other Study ID Numbers: PPI Trial
First Posted: January 19, 2006    Key Record Dates
Last Update Posted: January 19, 2006
Last Verified: January 2006

Additional relevant MeSH terms:
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action