Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers

Bleeding Peptic Ulcers Disease Clinical Trial

Official title:

Intravenous Infusion of High Dose Omeprazole Versus Regular Dose Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519519
• Other study ID #: 78:10/03-098
• Status: Completed
• Phase: Phase 3
• First received: August 21, 2007
• Last updated: February 8, 2017
• Start date: July 2004
• Est. completion date: November 2007

Study information

• Verified date: February 2017
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: November 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bleeding Peptic Ulcers Disease
• Hemorrhage
• Peptic Ulcer
• Peptic Ulcer Hemorrhage
• Ulcer

Intervention

Drug:
• Omeprazole
intravenous 80mg bolus followed by 8mg / hr for 3 days

Locations

Country	Name	City	State
Singapore	Department of Surgery, Singapore General Hospital	Outram Road, Singapore	Outram road
Singapore	Singapore General Hospital	Outram Road, Singapore	Outram Road
Singapore	Department of Surgery, Singapore General Hospital	Singapore	Outram road
Singapore	Singapore General Hospital	Singapore	Outram Road

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers		30 days after endoscopic therapy
Secondary	Surgery, Death and Length of hospital stay		30 days after endoscopic thearpy