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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00374101
Enrollment
450
Registered
2006-09-08
Start date
2005-01-31
Completion date
2007-03-31
Last updated
2007-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic Ulcers, Upper Gastrointestinal Bleeding

Keywords

PPIs,, endoscopic therapy,, peptic ulcers,, upper gastrointestinal bleeding,, non-variceal upper gastrointestinal bleeding

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.

Interventions

DRUGomeprazole
DRUGpantoprazole

Sponsors

Casa Sollievo della Sofferenza IRCCS
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rebleeding rates and surgical needs

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026