High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding
Overview[ - collapse ][ - ]
Purpose | High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy |
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Condition | Peptic Ulcers Upper Gastrointestinal Bleeding |
Intervention | Drug: omeprazole Drug: pantoprazole |
Phase | Phase 3 |
Sponsor | Casa Sollievo della Sofferenza IRCCS |
Responsible Party | Casa Sollievo della Sofferenza IRCCS |
ClinicalTrials.gov Identifier | NCT00374101 |
First Received | September 7, 2006 |
Last Updated | April 4, 2007 |
Last verified | April 2007 |
Tracking Information[ + expand ][ + ]
First Received Date | September 7, 2006 |
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Last Updated Date | April 4, 2007 |
Start Date | January 2005 |
Estimated Primary Completion Date | March 2007 |
Current Primary Outcome Measures | Rebleeding rates and surgical needs |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | High Versus Standard Dose of Proton Pump Inhibitors (PPIs) in Peptic Ulcer Bleeding |
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Official Title | Proton Pump Inhibitors in Conjunction to Endoscopic Therapy for Bleeding Peptic Ulcers: a Randomized Clinical Trial of High vs Standard Doses |
Brief Summary | High intravenous dosage of Proton Pump Inhibitors is not better than standard dosage in bleeding peptic ulcers successfully treated by endoscopic therapy |
Detailed Description | 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. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment |
Condition |
|
Intervention | Drug: omeprazole Drug: pantoprazole |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 450 |
Estimated Completion Date | March 2007 |
Estimated Primary Completion Date | Not Provided |
Eligibility Criteria | 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Italy |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00374101 |
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Other Study ID Numbers | 18/2004 |
Has Data Monitoring Committee | No |
Information Provided By | Casa Sollievo della Sofferenza IRCCS |
Study Sponsor | Casa Sollievo della Sofferenza IRCCS |
Collaborators | Not Provided |
Investigators | Principal Investigator: Andriulli Angelo, MD Division of Gastroenterology, "Casa Sollievo della Sofferenza", San Giovanni Rotondo, ITALY |
Verification Date | April 2007 |
Locations[ + expand ][ + ]
Division of Internal Medicine | Polla, Salerno, Italy |
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Division of Gastroenterology | Caserta, Italy |
DIvision of Gastroenterology | Como, Italy |
Division of Gastroenterology | Cosenza, Italy |
DIvision of Internal Medicine | Ivrea, Italy |
Division of Gastroenterology | Piacenza, Italy |
Division of Gastroenterology | San Giovanni Rotondo, Italy |
Division of Gastroenterology | Torino, Italy |
Division of Gastroenterology | Treviso, Italy |
Division of Gastroenterology | Vasto, Italy |