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Oral vs Intravenous and Proton Pump Inhibitor (PPI)for Peptic Ulcer Bleeding (PUB)

Primary Purpose

Upper Gastrointestinal Bleeding

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
lansoprazole
esomeprazole
Sponsored by
Changhua Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Upper Gastrointestinal Bleeding

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A peptic ulcer with active bleeding,a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base is observed within 24 hours of hospital admission

Exclusion Criteria:

  • Patients are excluded from the study if they are pregnant,
  • Do not obtain initial hemostasis with endoscopic injection of epinephrine
  • Do not give written informed consent
  • Have bleeding tendency (platelet count <50×109/L,serum prothrombin <30% of normal,or were taking anticoagulants)
  • Uremia.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    lansoprazole

    esomeprazole

    Arm Description

    lansoprazole 30 mg four times daily for three days followed by 30 mg once daily for two months

    esomeprazole 160 mg/day continuous infusion for three days followed by 40 mg once daily orally for two months

    Outcomes

    Primary Outcome Measures

    Re-bleeding within 14 days in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy
    recurrent bleeding before discharge and within 14 days

    Secondary Outcome Measures

    hospital stay
    we measure the above item in high risk patients during hospitalization and within one month
    volume of blood transfusion
    we measure the above item in high risk patients during hospitalization and within one month
    numbers of operation
    we measure the above item in high risk patients during hospitalization and within one month
    numbers of death
    we measure the above item in high risk patients during hospitalization and within one month

    Full Information

    First Posted
    April 13, 2010
    Last Updated
    February 13, 2020
    Sponsor
    Changhua Christian Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01123031
    Brief Title
    Oral vs Intravenous and Proton Pump Inhibitor (PPI)for Peptic Ulcer Bleeding (PUB)
    Official Title
    Oral vs Intravenous Proton Pump Inhibitor(PPI) in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy- a Prospective Randomized Comparative Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study was terminated and the PI has left the institution.
    Study Start Date
    April 2010 (undefined)
    Primary Completion Date
    March 2012 (Anticipated)
    Study Completion Date
    March 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Changhua Christian Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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 with bleeding peptic ulcers 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. Laine and Javid et al found that oral PPI and IV PPI had a similar intragastric pH response in the past two years. Therefore, whether oral can replace IV in the management of peptic ulcer bleeding is the objective in this study. The investigators enrolled 130 patients with active bleeding or nonbleeding visible vessels(NBVV) in this study. They are randomly assigned as oral lansoprazole or IV nexium group. All patients receive successful endoscopic therapy with heater probe or hemoclip placement. In the lansoprazole group (N=65), 30 mg four times daily is given orally for three days. Thereafter, the patients receive 30 mg lansoprazole orally daily for two months. In the nexium group, 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months. The primary end point is recurrent bleeding before discharge and within 14 days. At day 14, volume of blood transfused, number of surgeries performed, and the mortality rates of the two groups are compared as well.
    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 with bleeding peptic ulcers (1) and is now recommended as the first hemostatic modality for these patients (1, 2). In the past few years, adjuvant use of a high-dose proton pump inhibitor (PPI) after endoscopic therapy has been endorsed in some studies, two consensus statements and two meta-analysis (3-8). To sustain a high intragastric pH, a high dose of omeprazole has been used in previous studies concerning high-risk peptic ulcer bleeding. In our study, the investigators used 40 mg omeprazole intravenous bolus followed by 160 mg/day continuously infusion for three days. The mean intragastric pH rose to 6.0 one hour after the initial bolus of omeprazole in the omeprazole group; it persisted around this value for the rest of the 24 hours.7 The rebleeding rates were much lower in the PPI as compared with H2RA group (Day 3: 0/50 vs 8/50, p<0.01; Day 14: 2/50 vs 12/50, p<0.01) (4). How about the route of PPI usage? Oral or IV is the preferred route? Laine et al used oral lansoprazole in patients with peptic ulcer bleeding.9 They were randomly assigned to intravenous lansoprazole (90-mg bolus followed by 9-mg/h infusion) or oral lansoprazole (120-mg bolus followed by 30 mg every 3 hours). A pH was recorded for 24 hours. Mean pH rose above 6 after 2-3 hours of intravenous PPI and 3-4 hours of oral PPI. They concluded that frequent oral PPI may be able to replace the currently recommended intravenous bolus plus infusion PPI therapy in patients with bleeding ulcers. In one recent article, Javid et al also proved that there was no significant difference among various PPIs (omeprazole, pantoprazole, and rabeprazole) given through different routes (IV and oral routes) on raising intragastric pH above 6 for 72 h after successful endoscopic hemostasis in bleeding peptic ulcer.10 In our recent study, the investigators have proved that oral rabeprazole and IV omeprazole are equally effective in preventing rebleeding (13/78 in rabeprazole vs 12/78 in omeprazole, p>0.1) in high-risk bleeding peptic ulcers.11 All secondary outcomes between the two groups were similar, including the amount of blood transfusion, hospital stay, need for surgery and mortality. The objectives of this study are to assess the outcomes of two different regimens of oral lansoprazole vs high dose of intravenous nexium after endoscopic therapy in patients with peptic ulcer bleeding.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Upper Gastrointestinal Bleeding

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    lansoprazole
    Arm Type
    Active Comparator
    Arm Description
    lansoprazole 30 mg four times daily for three days followed by 30 mg once daily for two months
    Arm Title
    esomeprazole
    Arm Type
    Active Comparator
    Arm Description
    esomeprazole 160 mg/day continuous infusion for three days followed by 40 mg once daily orally for two months
    Intervention Type
    Drug
    Intervention Name(s)
    lansoprazole
    Other Intervention Name(s)
    takeprone
    Intervention Description
    lansoprazole 30 mg four times daily for three days followed by 30 mg once daily for two months
    Intervention Type
    Drug
    Intervention Name(s)
    esomeprazole
    Other Intervention Name(s)
    nexium
    Intervention Description
    esomeprazole 160 mg/day continuous infusion for three days followed by 40 mg once daily orally for two months
    Primary Outcome Measure Information:
    Title
    Re-bleeding within 14 days in Patients With Peptic Ulcer Bleeding After Successful Endoscopic Therapy
    Description
    recurrent bleeding before discharge and within 14 days
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    hospital stay
    Description
    we measure the above item in high risk patients during hospitalization and within one month
    Time Frame
    one year
    Title
    volume of blood transfusion
    Description
    we measure the above item in high risk patients during hospitalization and within one month
    Time Frame
    one year
    Title
    numbers of operation
    Description
    we measure the above item in high risk patients during hospitalization and within one month
    Time Frame
    one year
    Title
    numbers of death
    Description
    we measure the above item in high risk patients during hospitalization and within one month
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A peptic ulcer with active bleeding,a non-bleeding visible vessel (NBVV) or an adherent blood clot at the ulcer base is observed within 24 hours of hospital admission Exclusion Criteria: Patients are excluded from the study if they are pregnant, Do not obtain initial hemostasis with endoscopic injection of epinephrine Do not give written informed consent Have bleeding tendency (platelet count <50×109/L,serum prothrombin <30% of normal,or were taking anticoagulants) Uremia.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hwai J Lin, M.D.
    Organizational Affiliation
    Changhua Christian Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22681960
    Citation
    Yen HH, Yang CW, Su WW, Soon MS, Wu SS, Lin HJ. Oral versus intravenous proton pump inhibitors in preventing re-bleeding for patients with peptic ulcer bleeding after successful endoscopic therapy. BMC Gastroenterol. 2012 Jun 8;12:66. doi: 10.1186/1471-230X-12-66.
    Results Reference
    derived

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    Oral vs Intravenous and Proton Pump Inhibitor (PPI)for Peptic Ulcer Bleeding (PUB)

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