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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00519519
Enrollment
126
Registered
2007-08-22
Start date
2004-07-31
Completion date
2007-11-30
Last updated
2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding Peptic Ulcers Disease

Keywords

Rebleeding after endoscopic therapy

Brief summary

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.

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.

Interventions

DRUGOmeprazole

intravenous 80mg bolus followed by 8mg / hr for 3 days

Sponsors

Singapore General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

1. Above 21 year old 2. OGD done within 48 hrs of admission 3. No recent upper GIT surgery past one month 4. Forrest Type I, IIa & IIb ulcer (Type Ia: Spurting, Ib:Oozing, IIa: Visible vessel, IIb: Clot) 5. Non-malignant ulcer 6. Informed consent taken

Exclusion criteria

1. Impaired hepatic function 2. Pregnancy 3. Lactation 4. Concomitant medication (warfarin, diazepam, phenytoin, chlarithromycin, cimetidine and digoxin) 5. Underlying malignancy

Design outcomes

Primary

MeasureTime frame
Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers30 days after endoscopic therapy

Secondary

MeasureTime frame
Surgery, Death and Length of hospital stay30 days after endoscopic thearpy

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026