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Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers

This study has been completed.
Sponsor:
Information provided by:
Singapore General Hospital
ClinicalTrials.gov Identifier:
NCT00519519
First received: August 21, 2007
Last updated: October 29, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Bleeding Peptic Ulcers Disease
Drug: Omeprazole
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Singapore General Hospital:

Primary Outcome Measures:
  • Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers [ Time Frame: 30 days after endoscopic therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Surgery, Death and Length of hospital stay [ Time Frame: 30 days after endoscopic thearpy ] [ Designated as safety issue: Yes ]

Enrollment: 126
Study Start Date: July 2004
Study Completion Date: November 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519519

Locations
Singapore
Singapore General Hospital
Outram Road, Singapore, Outram Road, Singapore, 169608
Department of Surgery, Singapore General Hospital
Outram Road, Singapore, Outram road, Singapore, 169608
Singapore General Hospital
Singapore, Outram Road, Singapore, 169608
Department of Surgery, 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
  More Information

No publications provided by Singapore General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr weng Hoong Cha, Senior Consultant, department of Surgeey, Singapore General Hospital, Singapore General hospital
ClinicalTrials.gov Identifier: NCT00519519     History of Changes
Other Study ID Numbers: 78:10/03-098
Study First Received: August 21, 2007
Last Updated: October 29, 2008
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore General Hospital:
Rebleeding after endoscopic therapy

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

ClinicalTrials.gov processed this record on November 27, 2014