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.
Sponsor:
Information provided by:
Kwong Wah Hospital
ClinicalTrials.gov Identifier:
NCT00279123
First received: January 17, 2006
Last updated: NA
Last verified: January 2006
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
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
  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00279123     History of Changes
Other Study ID Numbers: PPI Trial
Study First Received: January 17, 2006
Last Updated: January 17, 2006
Health Authority: Hong Kong: Hospital Authority

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

ClinicalTrials.gov processed this record on October 29, 2014