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

Sponsor:	Kwong Wah Hospital
Information provided by:	Kwong Wah Hospital
ClinicalTrials.gov Identifier:	NCT00279123

Purpose

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.

Condition	Intervention	Phase
Peptic Ulcer Hemorrhage	Drug: pantoprazole infusion Drug: pantoprazole bolus Drug: no treatment	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy Peptic Ulcer

Drug Information available for: Pantoprazole Pantoprazole Sodium

U.S. FDA Resources

Further study details as provided by Kwong Wah Hospital:

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

Study Start Date:

January 2002

Eligibility

Genders Eligible for Study:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279123

Locations

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

Sponsors and Collaborators

Kwong Wah Hospital

Investigators

Principal Investigator:

Wai-ka Hung, MBBS

Department of Surgery, Kowng Wah Hospital

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00279123 History of Changes
Other Study ID Numbers:	PPI Trial
Study First Received:	January 17, 2006
Last Updated:	January 17, 2006
Health Authority:	Hong Kong: Hospital Authority

Additional relevant MeSH terms:

Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

Gastrointestinal Hemorrhage
Pantoprazole
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012