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A Study Comparing High Dose Omeprazole Infusion Against Scheduled Second Endoscopy for Bleeding Peptic Ulcer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00164931
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
Chinese University of Hong Kong

Brief Summary:
A prospective randomized study to compare the adjunctive use of high dose omeprazole infusion against scheduled second endoscopy in prevention of peptic ulcer rebleeding after therapeutic endoscopy.

Condition or disease Intervention/treatment Phase
Peptic Ulcer Hemorrhage Drug: Intravenous omeprazole infusion Procedure: Scheduled second endoscopy Phase 3

Detailed Description:

We have previously performed a prospective randomized controlled trial on the effect of scheduled second endoscopy upon peptic ulcer rebleeding. We found that the rate of recurrent bleeding was significantly reduced from 13.8% to 5% with a scheduled second endoscopy and appropriate therapy performed within 24 hours after initial hemostasis.

When we look at the studies in the literature employing proton pump inhibitors (PPI) infusion after primary endoscopic therapy, we found that there was also a significant reduction in the rate of rebleeding, the number of operation performed and the transfusion requirement.

Controversy exists regarding the optimal strategy to minimize recurrent peptic ulcer bleeding after successful endoscopic hemostasis. A recent cost-effective analysis on various strategies showed that selective scheduled second endoscopy strategy was probably the most effective and least expensive to prevent recurrent peptic ulcer bleeding.

We conduct a randomized trial on the cost-effectiveness of using omeprazole infusion vs scheduled second endoscopy on the management of bleeding peptic ulcers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Phase 3 Study of Prospective Randomized Trial Comparing Adjunctive High Dose Omeprazole Infusion Against Scheduled Second Endoscopy in the Prevention of Peptic Ulcer Rebleeding After Therapeutic Endoscopy
Study Start Date : October 2003

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Recurrent bleeding within 30 days after initial endoscopy defined as -
  2. Clinical criteria (anyone of the below)
  3. 1. Haemetmesis or fresh blood from Ryles tube
  4. 2. Fresh melena with shock (systolic blood pressure < 100mmHg or pulse >100/min) or drop in Hb > 2g/dl
  5. 3. Haemoglobin drop for more than 4 g/dl in 24 hours before 2nd therapeutic endoscopy
  6. 4. Blood transfusion of > 4 unit in 24 hours to stabilize Hb level or vital signs
  7. AND Endoscopic criteria of Forrest I a, b or II a, b

Secondary Outcome Measures :
  1. 1. The rate of surgery
  2. 2. Mortality
  3. 3. Length of Hospital stay
  4. 4. Transfusion


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:

  • all consecutive patients admitted for peptic ulcer bleeding (including bleeding anastomotic ulcers) with emergency endoscopy done in 24 hours after admission with Forrest type Ia, Ib, and IIa, IIb
  • age 15 - 90 years
  • Written consent available

Exclusion Criteria:

  • ulcer bleeding not controlled in first endoscopy
  • Bleeding from malignant ulcer or tumor
  • Bleeding from Dieulafoy lesion/ angiodysplasia
  • Bleeding from injection sclerotherapy ulcer
  • Patient with ASA category 5

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): NCT00164931


Locations
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China
Department of Surgery, United Christian Hospital
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Philip WY Chiu, MBChB, FRCSEd Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong
Principal Investigator: Henry KM Joeng, MBBS Department of Surgery, United Christian Hospital, Hong Kong
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ClinicalTrials.gov Identifier: NCT00164931    
Other Study ID Numbers: UCHCE03-43-SURG5
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: September 2005
Keywords provided by Chinese University of Hong Kong:
Peptic ulcer hemorrhage
Omeprazole
Scheduled second endoscopy
Additional relevant MeSH terms:
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Peptic Ulcer
Peptic Ulcer Hemorrhage
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