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

Primary Purpose

Peptic Ulcer Hemorrhage

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
pantoprazole infusion
pantoprazole bolus
no treatment
Sponsored by
Kwong Wah Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peptic Ulcer Hemorrhage

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

  • Department of Surgery, Kwong Wah Hospital

Outcomes

Primary Outcome Measures

Rebleeding rate within 30 days after endoscopic therapy

Secondary Outcome Measures

Transfusion requirement
duration of hospital stay
need for operative intervention
mortality rate
gastric pH
side effects of pantoprazole

Full Information

First Posted
January 17, 2006
Last Updated
January 17, 2006
Sponsor
Kwong Wah Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00279123
Brief Title
Effects of 2 Different Doses of Pantoprazole on Gastric pH and Recurrent Bleeding in Patients Who Bled From Peptic Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Kwong Wah Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pantoprazole infusion
Intervention Type
Drug
Intervention Name(s)
pantoprazole bolus
Intervention Type
Drug
Intervention Name(s)
no treatment
Primary Outcome Measure Information:
Title
Rebleeding rate within 30 days after endoscopic therapy
Secondary Outcome Measure Information:
Title
Transfusion requirement
Title
duration of hospital stay
Title
need for operative intervention
Title
mortality rate
Title
gastric pH
Title
side effects of pantoprazole

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai-ka Hung, MBBS
Organizational Affiliation
Department of Surgery, Kowng Wah Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Kwong Wah Hospital
City
Hong Kong
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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