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

NCT ID: NCT00279123

Last Updated: 2006-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2002-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Peptic Ulcer Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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pantoprazole infusion

Intervention Type DRUG

pantoprazole bolus

Intervention Type DRUG

no treatment

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kwong Wah Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Wai-ka Hung, MBBS

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Kowng Wah Hospital

Locations

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Department of Surgery, Kwong Wah Hospital

Hong Kong, , China

Site Status

Countries

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China

Other Identifiers

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PPI Trial

Identifier Type: -

Identifier Source: org_study_id