Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers
Primary Purpose
Bleeding Peptic Ulcers Disease
Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Bleeding Peptic Ulcers Disease focused on measuring Rebleeding after endoscopic therapy
Eligibility Criteria
Inclusion Criteria:
- Above 21 year old
- OGD done within 48 hrs of admission
- No recent upper GIT surgery past one month
- Forrest Type I, IIa & IIb ulcer (Type Ia: Spurting, Ib:Oozing, IIa: Visible vessel, IIb: Clot)
- Non-malignant ulcer
- Informed consent taken
Exclusion Criteria:
- Impaired hepatic function
- Pregnancy
- Lactation
- Concomitant medication (warfarin, diazepam, phenytoin, chlarithromycin, cimetidine and digoxin)
- Underlying malignancy
Sites / Locations
- Department of Surgery, Singapore General Hospital
- Singapore General Hospital
- Department of Surgery, Singapore General Hospital
- Singapore General Hospital
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
2
Arm Description
regular dose versus high dose
Outcomes
Primary Outcome Measures
Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers
Secondary Outcome Measures
Surgery, Death and Length of hospital stay
Full Information
NCT ID
NCT00519519
First Posted
August 21, 2007
Last Updated
February 8, 2017
Sponsor
Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00519519
Brief Title
Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers
Official Title
Intravenous Infusion of High Dose Omeprazole Versus Regular Dose Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Singapore General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding Peptic Ulcers Disease
Keywords
Rebleeding after endoscopic therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2
Arm Type
Active Comparator
Arm Description
regular dose versus high dose
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
intravenous 40 mg om for 3 days
Intervention Description
intravenous 80mg bolus followed by 8mg / hr for 3 days
Primary Outcome Measure Information:
Title
Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers
Time Frame
30 days after endoscopic therapy
Secondary Outcome Measure Information:
Title
Surgery, Death and Length of hospital stay
Time Frame
30 days after endoscopic thearpy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Above 21 year old
OGD done within 48 hrs of admission
No recent upper GIT surgery past one month
Forrest Type I, IIa & IIb ulcer (Type Ia: Spurting, Ib:Oozing, IIa: Visible vessel, IIb: Clot)
Non-malignant ulcer
Informed consent taken
Exclusion Criteria:
Impaired hepatic function
Pregnancy
Lactation
Concomitant medication (warfarin, diazepam, phenytoin, chlarithromycin, cimetidine and digoxin)
Underlying malignancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weng Hoong Chan, MBBS, FRCS
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Weng Hoong Chan, MBBS, FRCS
Organizational Affiliation
Department of Surgery, Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Singapore General Hospital
City
Outram Road, Singapore
State/Province
Outram road
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Singapore General Hospital
City
Outram Road, Singapore
State/Province
Outram Road
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Department of Surgery, Singapore General Hospital
City
Singapore
State/Province
Outram road
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Singapore General Hospital
City
Singapore
State/Province
Outram Road
ZIP/Postal Code
169608
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
21305536
Citation
Chan WH, Khin LW, Chung YF, Goh YC, Ong HS, Wong WK. Randomized controlled trial of standard versus high-dose intravenous omeprazole after endoscopic therapy in high-risk patients with acute peptic ulcer bleeding. Br J Surg. 2011 May;98(5):640-4. doi: 10.1002/bjs.7420. Epub 2011 Feb 8.
Results Reference
derived
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Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers
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