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Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv

Primary Purpose

Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Esomeprazole
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal reflux disease, Nexium, Esomeprazole, Administration methods.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Heartburn on 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis) or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
  • Body Mass Index within the limits specified in the protocol.

Exclusion Criteria:

  • History of esophageal, duodenal or gastric surgery
  • History of severe liver disease.
  • Any other significant disease or pathology judged to be clinically significant by the investigator.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    1

    2

    Arm Description

    20mg oral

    20mg IV

    Outcomes

    Primary Outcome Measures

    To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.

    Secondary Outcome Measures

    To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium.
    To compare maximum acid output when switching between Oral and IV adminstration of Nexium
    Safety assessment via adverse event recording.

    Full Information

    First Posted
    February 21, 2008
    Last Updated
    January 21, 2011
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00626262
    Brief Title
    Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv
    Official Title
    An Open, Randomised Two Way Crossover Study Comparing the Effects of 20mg of Esomeprazole Administered Orally and Intravenously as a 3 Minute Injection on Basal and Pentagastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2002 (undefined)
    Primary Completion Date
    October 2002 (Actual)
    Study Completion Date
    October 2002 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to examine the effects of Nexium at a dose of 20mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux Disease
    Keywords
    Gastroesophageal reflux disease, Nexium, Esomeprazole, Administration methods.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Description
    20mg oral
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    20mg IV
    Intervention Type
    Drug
    Intervention Name(s)
    Esomeprazole
    Other Intervention Name(s)
    Nexium
    Intervention Description
    Oral and Intravenous
    Primary Outcome Measure Information:
    Title
    To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.
    Time Frame
    Every 10 days
    Secondary Outcome Measure Information:
    Title
    To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium.
    Time Frame
    Post Day 10
    Title
    To compare maximum acid output when switching between Oral and IV adminstration of Nexium
    Time Frame
    Post Day 10
    Title
    Safety assessment via adverse event recording.
    Time Frame
    At each visit

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Heartburn on 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis) or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE. Body Mass Index within the limits specified in the protocol. Exclusion Criteria: History of esophageal, duodenal or gastric surgery History of severe liver disease. Any other significant disease or pathology judged to be clinically significant by the investigator.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paula Fernstrom
    Organizational Affiliation
    Nexium Global Product Director, AstraZeneca
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv

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