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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00519519
Other study ID # 78:10/03-098
Secondary ID
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
Health authority
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

Study Design


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