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

August 21, 2007
October 29, 2008
July 2004
October 2007   (final data collection date for primary outcome measure)
Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers [ Time Frame: 30 days after endoscopic therapy ] [ Designated as safety issue: Yes ]
Re-bleeding rate after endoscopic treatment of bleeding peptic ulcers [ Time Frame: 30 days after endoscopic therapy ]
Complete list of historical versions of study NCT00519519 on ClinicalTrials.gov Archive Site
Surgery, Death and Length of hospital stay [ Time Frame: 30 days after endoscopic thearpy ] [ Designated as safety issue: Yes ]
Surgery, Death and Length of hopsital stay [ Time Frame: 30 days after endoscopic thearpy ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Bleeding Peptic Ulcers Disease
Drug: Omeprazole
intravenous 80mg bolus followed by 8mg / hr for 3 days
Other Name: intravenous 40 mg om for 3 days
Active Comparator: 2
regular dose versus high dose
Intervention: Drug: Omeprazole
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
126
November 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00519519
78:10/03-098
No
Dr weng Hoong Cha, Senior Consultant, department of Surgeey, Singapore General Hospital, Singapore General hospital
Singapore General Hospital
Not Provided
Principal Investigator: Weng Hoong Chan, MBBS, FRCS Singapore General Hospital
Principal Investigator: Weng Hoong Chan, MBBS, FRCS Department of Surgery, Singapore General Hospital
Singapore General Hospital
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP