Status:
TERMINATED
Effect of High-dose Oral Rabeprazole on Recurrent Bleeding After the Endoscopic Treatment of Bleeding Peptic Ulcers
Lead Sponsor:
The Catholic University of Korea
Collaborating Sponsors:
Janssen Korea, Ltd., Korea
Conditions:
Peptic Ulcer Hemorrhage
Eligibility:
All Genders
16+ years
Phase:
PHASE4
Brief Summary
This study is conducted to compare and evaluate the effect of administering a high-dose intravenous proton pump inhibitors or high-dose oral Rabeprazole in preventing recurrent bleeding after the endo...
Detailed Description
0.1 % of hospitalized patients are attributed to upper gastrointestinal bleeding every year in the U.S. and Europe, among which peptic ulcer is the most common cause of upper gastrointestinal bleeding...
Eligibility Criteria
Inclusion
- Bleeding peptic ulcer: Among patients suspected to have upper GI bleeding based on hematemesis or melena, those with peptic ulcers(Forrest I, IIa and IIb) in whom active bleeding, non-bleeding visible vessels and fresh blood clots are observed on upper GI endoscopy performed within 24 hours after the hospitalization
- patients who achieved primary hemostasis with endoscopic hemostasis procedure via upper GI endoscopy
Exclusion
- Patients who refuse endoscopic procedure
- Patients with complications from gastric ulcer that require operative treatment prior to upper GI endoscopic treatment(e.g., gastric outlet obstruction, peptic ulcer perforation)
- Pregnancy
- Patients with serious concurrent diseases such as malignant tumors or end-stage diseases
- History of previous gastrectomy or vagotomy
- Known hypersensitivity to proton pump inhibitors
- Elderly patients
- Epilepsy
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00838682
Start Date
April 1 2006
End Date
March 1 2009
Last Update
September 24 2010
Active Locations (2)
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1
Bucheon St. Mary's Hospital
Bucheon-si, Kyungkido, South Korea
2
Uijeongbu St.Mary's Hospital
Uijeongbu-si, Kyungkido, South Korea