Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers

Phase 3

Completed

• Conditions: Bleeding Peptic Ulcers Disease
• Interventions: Drug: Omeprazole

• Registration Number: NCT00519519
• Lead Sponsor: Singapore General Hospital

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.

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2007-08-21
• Study First Submitted QC: 2007-08-21
• Study First Posted: 2007-08-22
• Primary Completion: 2007-10
• Study Completion: 2007-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	Omeprazole	regular dose versus high dose

Primary Outcome Measures

Name	Time	Method
Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers	30 days after endoscopic therapy

Secondary Outcome Measures

Name	Time	Method
Surgery, Death and Length of hospital stay	30 days after endoscopic thearpy

Trial Locations

Locations (2)

Department of Surgery, Singapore General Hospital; 🇸🇬 Singapore, Outram road, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Outram Road, Singapore