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

Condition(s) targeted: Peptic Ulcer Hemorrhage

Intervention: pantoprazole infusion (Drug); pantoprazole bolus (Drug); no treatment (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Kwong Wah Hospital

Official(s) and/or principal investigator(s):
Wai-ka Hung, MBBS, Principal Investigator, Affiliation: Department of Surgery, Kowng Wah Hospital

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.

Study design: Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Rebleeding rate within 30 days after endoscopic therapy

Secondary outcome:

Transfusion requirement

duration of hospital stay

need for operative intervention

mortality rate

gastric pH

side effects of pantoprazole

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Department of Surgery, Kwong Wah Hospital, Hong Kong, China

Starting date: January 2002
Last updated: January 17, 2006