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Different Dose of Intravenous Omeprazole to Treat Bleeding Ulcer With Adherent Clot

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ClinicalTrials.gov Identifier: NCT02536989
Recruitment Status : Completed
First Posted : September 1, 2015
Last Update Posted : February 8, 2016
Sponsor:
Information provided by (Responsible Party):
Tzong-Hsi Lee, Far Eastern Memorial Hospital

Brief Summary:

The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer.

The investigators define rebleeding during admission and within 30 days as primary end points and define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.


Condition or disease Intervention/treatment Phase
Peptic Ulcer Hemorrhage Drug: omeprazole Phase 4

Detailed Description:

The investigators will include those patients with adherent clot on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe). After receiving well explanation and giving written consent, they are enrolled and will be allocated to 2 groups randomly. Those in the first group will receive intravenous omeprazole 40 mg stat and then 40 mg q12h. Those in the second group will receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion. The patients in both groups will receive intravenous omeprazole for 3 days and then oral esomeprazole qd for further treatment of peptic ulcer. The investigators will record the basic data of these patients including age, sex, use of NSAID or anit-coagulant, concomitant major diseases; clinical data including Hb, Plt, PT, the lowest systolic pressure before allocation and heart rate at the same time, shock status, transfusion amount before allocation; endoscopic findings including the location & size of ulcer, size of clot, existence of fresh blood in stomach or duodenum. The investigators will monitor the events of rebleeding during admission and within 30 days, surgery for ulcer bleeding and mortality within 30 days and record the amount of transfusion and hospitalization days after allocation. When rebleeding is suspected , those patient will receive endoscopic examination and appropriate therapy. Further treatment with surgical or angiographic intervention is decided by the attending physicians.These patients will be monitored during admission (2 weeks in average)and then followed up in GI outpatient clinics.

The investigators define rebleeding during admission and within 30 days as primary end points. Rebleeding is defined as the one of the clinical manifestations occurring 6 hours after allocation: 1.hematemesis or bloody stool 2. tarry stool and hemodynamic change (systolic pressure less than 90 mmHg, or heart more than 110 beats per minute ) 3. decrease of Hb more than 2g/dl within 24 hours after elevation of Hb to 10 g/dl with transfusion. The investigators define surgical intervention for ulcer bleeding, transfusion amount and hospitalization days after allocation as secondary end points.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of High Dose Infusion and Low Dose Bolus Intravenous Omeprazole for Treatment of Bleeding Ulcer With Adherent Clot
Study Start Date : March 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
receive high dose PPI treament with intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days
Drug: omeprazole
receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days
Other Name: Losec, iv, high dose

Active Comparator: 2
receive usual dose PPI treatment with ntravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days
Drug: omeprazole
receive intravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days
Other Name: Losec, iv, usual dose




Primary Outcome Measures :
  1. rebleeding rate within 30 days after allocation [ Time Frame: within 30 days after allocation ]

Secondary Outcome Measures :
  1. blood transfusion units needed within 30 days after allocation [ Time Frame: within 30 days after allocation ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • We will include those patients with adherent clot, more than 5 mm, on gastric or duodenal ulcers after endoscopic confirmation and exclusion of other possible bleeder. Adherent clot is defined that still stays on the ulcer after 200 ml normal saline irrigation (4 times of irrigation with 50 ml syringe).

Exclusion Criteria:

  • ulcer with active bleeding, suspected malignant ulcer, patients with age less than 18 years old, or allergy to omeprazole

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): NCT02536989


Locations
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Taiwan
Far Eastern Memorial Hospital
Taipei, Taiwan, 22050
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
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Principal Investigator: Tzong-Hsi Lee, M.D. Far Eastern Memorial Hospital

Publications:

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Responsible Party: Tzong-Hsi Lee, M.D., Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT02536989     History of Changes
Other Study ID Numbers: FEMH-96-C009
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: February 8, 2016
Last Verified: August 2010
Keywords provided by Tzong-Hsi Lee, Far Eastern Memorial Hospital:
peptic ulcer bleeding
blood clot
dose
Additional relevant MeSH terms:
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Peptic Ulcer
Ulcer
Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action