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Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy (lowdosePPI)

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: NCT04407832
Recruitment Status : Withdrawn
First Posted : May 29, 2020
Last Update Posted : May 29, 2020
Sponsor:
Collaborators:
Taipei Medical University Hospital
Dalin Tzu Chi General Hospital
Information provided by (Responsible Party):
Changhua Christian Hospital

Brief Summary:

The investigators used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.

The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.


Condition or disease Intervention/treatment Phase
Peptic Ulcer Bleeding Device: heat probe or hemoclip Not Applicable

Detailed Description:

A bleeding peptic ulcer remains a serious medical problem with significant morbidity and mortality. Endoscopic therapy significantly reduces further bleeding, surgery, and mortality in patients receiving intravenous Proton Pump Inhibitor (PPI)and is now recommended as the first hemostatic modality for these patients. In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, including two consensus statements and two meta-analysis. To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. However, in one recent published metaanalysis found that low dose PPI may be as effective as high dose PPI in preventing further bleeding in high-risk patients. Therefore, one double blind study is needed clarify this puzzle.

We used two different doses of esomeprazole (40 mg IV q.d. and 40 mg IV q6h for three days followed by esomeprazole 40 mg q.d. orally in two groups) after successful endoscopic therapy with heat probe therapy or hemoclip placement.

The goal of this study is to assess the outcomes of two different regimens of low vs. high dose of intravenous esomeprazole after endoscopic therapy in patients with peptic ulcer bleeding.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding
Study Start Date : August 2011
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: low dose PPI
40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months
Device: heat probe or hemoclip
for hemostasis
Other Name: Olympus co.

Active Comparator: high dose PPI
40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months
Device: heat probe or hemoclip
for hemostasis
Other Name: Olympus co.




Primary Outcome Measures :
  1. further bleeding [ Time Frame: 14 days ]
    Number of participants with rebleeding within 14 days


Secondary Outcome Measures :
  1. hospital stay [ Time Frame: 30 days ]
    hospital stay in day

  2. need of blood transfusion [ Time Frame: 30 days ]
    number of participants need of blood transufion

  3. surgical intervention [ Time Frame: 30 days ]
    number of participants need surgical intervention to manage bleeding

  4. mortality [ Time Frame: 30 days ]
    number of participants death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with peptic ulcer bleeding with active bleeding or nonbleeding visible (initial Hb<10, shock, or coffee grounds or blood in stomach)

Exclusion Criteria:

  • age >90y/o
  • pregnant woman
  • allergic to esomeprazole
  • unwilling to enter this study
  • bleeding tendency
  • severe co-morbid illness, including cancer, hepatic failure, renal failure,

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): NCT04407832


Locations
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Taiwan
Division of Gastroenterology, TMUH
Taipei, Taiwan, 110
Sponsors and Collaborators
Changhua Christian Hospital
Taipei Medical University Hospital
Dalin Tzu Chi General Hospital
Investigators
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Principal Investigator: Hwai-jeng Lin, M.D. Taipei Medical University Hospital
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Responsible Party: Changhua Christian Hospital
ClinicalTrials.gov Identifier: NCT04407832    
Other Study ID Numbers: lowdosePPI
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Keywords provided by Changhua Christian Hospital:
hemostasis
heat probe
hemoclip
rebleeding
Additional relevant MeSH terms:
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Peptic Ulcer
Peptic Ulcer Hemorrhage
Hemorrhage
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Gastrointestinal Hemorrhage