Status:
TERMINATED
A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Gastrointestinal Hemorrhage
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
The investigators hypothesize that high dose esomeprazole 80mg given as a bolus, followed by 8mg/h would render gastric pH near neutral and that pH control with esomeprazole given in such a high dose ...
Detailed Description
Bleeding peptic ulcer is a common and life threatening condition. Endoscopic therapy has become the mainstay of controlling bleeding. Recurrent bleeding after endoscopic control occurs in about 20% of...
Eligibility Criteria
Inclusion
- Patients admitted with diagnosis of upper gastrointestinal bleeding aged between 18 and 80
- Endoscopic confirmation of a bleeding duodenal or gastric ulcer to which endoscopic control has been obtained
- Absence of H. pylori infection
- Informed written consent
Exclusion
- Known incompatibility to the study drugs;
- Known incompatibility and hypersensitivity to proton pump inhibitor
- H. pylori infection
- Recent H2RA or PPI use (within last 4 weeks)
- Concomitant use of medications that may interfere gastric acid secretion or motility (e.g. anticholinergic, metoclopramide, domperidone)
- Pregnancy or lactation;
- Non-compliance e.g. mental subordination
- Nasopharyngeal or oropharyngeal pathology that would prevent passage of a nasal catheter
- Significant liver disease as PPI is metabolized by the cytochrome P-450 system
- Previous gastric surgery
- Chronic Aspirin user
- Presence of esophageal/ gastric varices
- Moribund patients, terminal malignancy \& patients with severe renal disease
- Patient unable to give written consent
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00164788
Start Date
July 1 2004
End Date
January 1 2011
Last Update
August 28 2012
Active Locations (1)
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1
Endoscopy Center, Prince of Wales Hospital
Hong Kong (sar), China