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

This study has been completed.
Information provided by:
Kwong Wah Hospital Identifier:
First received: January 17, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted

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 Intervention Phase
Peptic Ulcer Hemorrhage Drug: pantoprazole infusion Drug: pantoprazole bolus Drug: no treatment Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Kwong Wah Hospital:

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

Secondary Outcome Measures:
  • Transfusion requirement
  • duration of hospital stay
  • need for operative intervention
  • mortality rate
  • gastric pH
  • side effects of pantoprazole

Study Start Date: January 2002

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

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
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Please refer to this study by its identifier: NCT00279123

Department of Surgery, Kwong Wah Hospital
Hong Kong, China
Sponsors and Collaborators
Kwong Wah Hospital
Principal Investigator: Wai-ka Hung, MBBS Department of Surgery, Kowng Wah Hospital
  More Information Identifier: NCT00279123     History of Changes
Other Study ID Numbers: PPI Trial
Study First Received: January 17, 2006
Last Updated: January 17, 2006

Additional relevant MeSH terms:
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on June 23, 2017