- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00519519
Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers
Intravenous Infusion of High Dose Omeprazole Versus Regular Dose Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction
Peptic ulcer bleeding (PUB) is a common and life threatening condition. Intravenous infusion of high dose omeprazole (80mg as bolus followed by 8 mg/hr for 72 hours ie 652 mg/72 hrs) after endoscopic therapy resulted in greater reductions of re-bleeding than did placebo. Thus the above regime became our departmental protocol. However, there is some evidence that both high dose and a regular dose of omeprazole (40mg once a day followed by a saline infusion ie 120mg/72 hrs) would be equally effective. We calculated that high dose regimen is about S$ 500 more expensive. The aim of our study is to determine the equivalence of both regimes in preventing re-bleeding rate (primary end-point), surgery and mortality in PUB patients.
Study design This is a single institution prospective randomized double-blind study. All patient with PUB (Forrest classification I, IIa and IIb: spurting or oozing bleeding, visible vessels and clot) had endoscopic treatments (adrenaline injection and/or heater probe). After successful endoscopic hemostasis, patients are randomized to receive a high or regular dose of omeprazole infusion. After 72 hours, both groups of patients are given oral omeprazole 40mg daily for 4 weeks. All patients are evaluated at the clinic at the end of 4 weeks. The primary end-point is rebleeding. Other secondary endpoints measured are surgery, duration of hospital stay and death.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Outram Road
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Outram Road, Singapore, Outram Road, Singapore, 169608
- Singapore General Hospital
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Singapore, Outram Road, Singapore, 169608
- Singapore General Hospital
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Outram road
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Outram Road, Singapore, Outram road, Singapore, 169608
- Department of Surgery, Singapore General Hospital
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Singapore, Outram road, Singapore, 169608
- Department of Surgery, Singapore General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Above 21 year old
- OGD done within 48 hrs of admission
- No recent upper GIT surgery past one month
- Forrest Type I, IIa & IIb ulcer (Type Ia: Spurting, Ib:Oozing, IIa: Visible vessel, IIb: Clot)
- Non-malignant ulcer
- Informed consent taken
Exclusion Criteria:
- Impaired hepatic function
- Pregnancy
- Lactation
- Concomitant medication (warfarin, diazepam, phenytoin, chlarithromycin, cimetidine and digoxin)
- Underlying malignancy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
regular dose versus high dose
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intravenous 80mg bolus followed by 8mg / hr for 3 days
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers
Time Frame: 30 days after endoscopic therapy
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30 days after endoscopic therapy
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Surgery, Death and Length of hospital stay
Time Frame: 30 days after endoscopic thearpy
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30 days after endoscopic thearpy
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Weng Hoong Chan, MBBS, FRCS, Singapore General Hospital
- Principal Investigator: Weng Hoong Chan, MBBS, FRCS, Department of Surgery, Singapore General Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Stomach Diseases
- Intestinal Diseases
- Duodenal Diseases
- Gastrointestinal Hemorrhage
- Ulcer
- Hemorrhage
- Peptic Ulcer
- Peptic Ulcer Hemorrhage
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Omeprazole
Other Study ID Numbers
- 78:10/03-098
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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