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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Recruitment Status : Withdrawn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

Tracking Information
First Submitted Date  ICMJE August 4, 2011
First Posted Date  ICMJE May 29, 2020
Last Update Posted Date May 29, 2020
Study Start Date  ICMJE August 2011
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
further bleeding [ Time Frame: 14 days ]
Number of participants with rebleeding within 14 days
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2020)
  • hospital stay [ Time Frame: 30 days ]
    hospital stay in day
  • need of blood transfusion [ Time Frame: 30 days ]
    number of participants need of blood transufion
  • surgical intervention [ Time Frame: 30 days ]
    number of participants need surgical intervention to manage bleeding
  • mortality [ Time Frame: 30 days ]
    number of participants death
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Two Doses of IV Esomeprazole After Successful Endoscopic Therapy
Official Title  ICMJE A Double Blind Study Comparing Low Dose and High Dose IV Esomeprazole After Successful Endoscopic Therapy in Patients With Peptic Ulcer Bleeding
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Peptic Ulcer Bleeding
Intervention  ICMJE Device: heat probe or hemoclip
for hemostasis
Other Name: Olympus co.
Study Arms  ICMJE
  • Active Comparator: low dose PPI
    40 mg esomeprazole IV for three days followed by esomeprazole 40 mg po daily for two months
    Intervention: Device: heat probe or hemoclip
  • Active Comparator: high dose PPI
    40 mg esomeprazole IV every 6 hr for 3 days followed by 40 mg po daily for two months
    Intervention: Device: heat probe or hemoclip
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 27, 2020)
0
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2013
Estimated Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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,
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04407832
Other Study ID Numbers  ICMJE lowdosePPI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Changhua Christian Hospital
Study Sponsor  ICMJE Changhua Christian Hospital
Collaborators  ICMJE
  • Taipei Medical University Hospital
  • Dalin Tzu Chi General Hospital
Investigators  ICMJE
Principal Investigator: Hwai-jeng Lin, M.D. Taipei Medical University Hospital
PRS Account Changhua Christian Hospital
Verification Date May 2020

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