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

C

Casa Sollievo della Sofferenza IRCCS

Status and phase

Completed
Phase 3

Conditions

Peptic Ulcers
Upper Gastrointestinal Bleeding

Treatments

Drug: pantoprazole
Drug: omeprazole

Study type

Interventional

Funder types

Other

Identifiers

NCT00374101
18/2004

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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