A Phase 3 interventional study of Omeprazole in Bleeding Peptic Ulcers Disease, sponsored by Singapore General Hospital. Completed at 4 sites in Singapore. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2017-02-10.
Sponsored by Singapore General Hospital · Phase 3, Interventional, and Treatment
Bleeding peptic ulcers are one of the major causes of morbidity and mortality for hospital emergency admissions.The initial treatment is endoscopic therapy followed by intravenous omeprazole. However the optimal dosage of omeprazole is not known. We conducted this study to find out the optimal dosage in such clinical scenario.
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.
193 studies on the registry are indexed under Peptic Ulcer; 31 are open to participants now.
This study's enrollment of 126 is below the median of 150 across 142 interventional studies indexed under Peptic Ulcer.
Browse Peptic Ulcer studies →Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
regular dose versus high dose
Drug: Omeprazole
intravenous 80mg bolus followed by 8mg / hr for 3 days
Also known as: intravenous 40 mg om for 3 days
Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers
Time frame: 30 days after endoscopic therapy
Surgery, Death and Length of hospital stay
Time frame: 30 days after endoscopic thearpy
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Singapore General Hospital