High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding

This study has been completed.
Sponsor:
Information provided by:
Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier:
NCT00374101
First received: September 7, 2006
Last updated: April 4, 2007
Last verified: April 2007

September 7, 2006
April 4, 2007
January 2005
Not Provided
Rebleeding rates and surgical needs
Same as current
Complete list of historical versions of study NCT00374101 on ClinicalTrials.gov Archive Site
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High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding
Proton Pump Inhibitors in Conjunction to Endoscopic Therapy for Bleeding Peptic Ulcers: a Randomized Clinical Trial of High vs Standard Doses

High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy

The recent Canadian consensus conference on the management of patients with non-variceal upper gastrointestinal bleeding recommends a high regimen of PPIs, consisting in a dosage of 80-mg bolus followed by the 8 mg/H infusion, as being superior to the standard dosage (40 mg twice daily by bolus injection) in conjunction with some type of endoscopic therapy. However, by pooling data fromm studies comparing high doses of PPIs as continuous infusion versus regular doses as intermittent bolus, rebleeding, surgery, and mortality were not significantly different. As the previous conclusion became apparent in a meta-analytical evaluation of only 2 randomized clinical trials, more studies are needed on this topic.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Peptic Ulcers
  • Upper Gastrointestinal Bleeding
  • Drug: omeprazole
  • Drug: pantoprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
450
March 2007
Not Provided

Inclusion Criteria:

  • Consecutive patients admitted for upper gastrointestinal bleeding secondary to peptic ulcers that have been successfully treated with endoscopic therapy

Exclusion Criteria:

  • Variceal esophageal bleeding
  • Concurrent PPI use
  • Moribund patients
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00374101
18/2004
No
Not Provided
Casa Sollievo della Sofferenza IRCCS
Not Provided
Principal Investigator: Andriulli Angelo, MD Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY
Casa Sollievo della Sofferenza IRCCS
April 2007

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