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
1 other identifier
interventional
126
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2004
Typical duration for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 21, 2007
CompletedFirst Posted
Study publicly available on registry
August 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedFebruary 10, 2017
February 1, 2017
3.3 years
August 21, 2007
February 8, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers
30 days after endoscopic therapy
Secondary Outcomes (1)
Surgery, Death and Length of hospital stay
30 days after endoscopic thearpy
Study Arms (1)
2
ACTIVE COMPARATORregular dose versus high dose
Interventions
intravenous 80mg bolus followed by 8mg / hr for 3 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Impaired hepatic function
- Pregnancy
- Lactation
- Concomitant medication (warfarin, diazepam, phenytoin, chlarithromycin, cimetidine and digoxin)
- Underlying malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Department of Surgery, Singapore General Hospital
Outram Road, Singapore, Outram Road, 169608, Singapore
Singapore General Hospital
Outram Road, Singapore, Outram Road, 169608, Singapore
Department of Surgery, Singapore General Hospital
Singapore, Outram Road, 169608, Singapore
Singapore General Hospital
Singapore, Outram Road, 169608, Singapore
Related Publications (1)
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.
PMID: 21305536DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Weng Hoong Chan, MBBS, FRCS
Singapore General Hospital
- PRINCIPAL INVESTIGATOR
Weng Hoong Chan, MBBS, FRCS
Department of Surgery, Singapore General Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2007
First Posted
August 22, 2007
Study Start
July 1, 2004
Primary Completion
October 1, 2007
Study Completion
November 1, 2007
Last Updated
February 10, 2017
Record last verified: 2017-02