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Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers

K

Kwong Wah Hospital

Status and phase

Completed
Phase 4

Conditions

Peptic Ulcer Hemorrhage

Treatments

Drug: no treatment
Drug: pantoprazole bolus
Drug: pantoprazole infusion

Study type

Interventional

Funder types

Other

Identifiers

NCT00279123
PPI Trial

Details and patient eligibility

About

Endoscopic treatment of bleeding peptic ulcers is effective to prevent rebleeding. Adjuvant medical treatment to increase gastric pH may further decrease rebleeding. Recent studies on potent acid suppression by proton pump inhibitors (PPI) demonstrated the efficacy in preventing rebleeding. Lau demonstrated that high dose intravenous infusion of omeprazole decreased rebleeding in peptic ulcers with stigmata of recent hemorrhage.

There is little data regarding the effect of pantoprazole on bleeding peptic ulcers. Furthermore, the optimal dose of PPI is unknown. Few studies have included measurement of gastric pH in addition to clinical outcome.

This study compares the effect of two doses of intravenous pantoprazole with no acid suppression in bleeding peptic ulcers after endoscopic therapy. In addition to the usual clinical endpoints, gastric pH is monitored to study the relation of pH elevation and the clinical outcome.

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • patients presenting with upper gastrointestinal bleeding with upper endoscopy showing a bleeding peptic ulcer with major stigmata of haemorrhage and after successful endoscopic haemostasis.

Exclusion criteria

  • previous gastrectomy and vagotomy
  • patient taking warfarin
  • intake of anti-secretory drugs in the previous 48 hours

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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