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Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers

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ClinicalTrials.gov Identifier: NCT00519519
Recruitment Status : Completed
First Posted : August 22, 2007
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bleeding Peptic Ulcers Disease Drug: Omeprazole Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Infusion of High Dose Omeprazole Versus Regular Dose Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers
Study Start Date : July 2004
Actual Primary Completion Date : October 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 2
regular dose versus high dose
Drug: Omeprazole
intravenous 80mg bolus followed by 8mg / hr for 3 days
Other Name: intravenous 40 mg om for 3 days




Primary Outcome Measures :
  1. Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers [ Time Frame: 30 days after endoscopic therapy ]

Secondary Outcome Measures :
  1. Surgery, Death and Length of hospital stay [ Time Frame: 30 days after endoscopic thearpy ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00519519


Locations
Singapore
Department of Surgery, Singapore General Hospital
Outram Road, Singapore, Outram road, Singapore, 169608
Singapore General Hospital
Outram Road, Singapore, Outram Road, Singapore, 169608
Department of Surgery, Singapore General Hospital
Singapore, Outram road, Singapore, 169608
Singapore General Hospital
Singapore, Outram Road, Singapore, 169608
Sponsors and Collaborators
Singapore General Hospital
Investigators
Principal Investigator: Weng Hoong Chan, MBBS, FRCS Singapore General Hospital
Principal Investigator: Weng Hoong Chan, MBBS, FRCS Department of Surgery, Singapore General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Singapore General Hospital
ClinicalTrials.gov Identifier: NCT00519519     History of Changes
Other Study ID Numbers: 78:10/03-098
First Posted: August 22, 2007    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by Singapore General Hospital:
Rebleeding after endoscopic therapy

Additional relevant MeSH terms:
Ulcer
Hemorrhage
Peptic Ulcer
Peptic Ulcer Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action