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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)

Primary Purpose

Gastroesophageal Reflux Disease (GERD)

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

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease (GERD) focused on measuring Gastroesophageal Reflux Disease, GERD, Esomeprazole, Heartburn, Nexium

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A history of heartburn or acid regurgitation for 3 months or longer or any history of erosive esophagitis.
  • Nightime heartburn averaging at least 2 or 3 times per week and a history of sleep disturbances associated with GERD for 1 month or more.
  • Nightime heartburn graded as moderate or severe on 3 of the last 7 days of the run-in period and sleep disturbances associated with GERD as documented in the run-in diary card on at least 3 of the last 7 days of the run-in period..

Exclusion Criteria:

  • Any condition other than GERD that is either the primary cause of, or a significant contributor to the patients sleep disturbance.
  • Shift workers who work between 12am (midnight) and 6am.
  • Sleep medication, antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable for at least 3 months or is not expected to remain stable during the patients participation in the study.
  • Other diseases / conditions as listed in the protocol.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    Arm Description

    Outcomes

    Primary Outcome Measures

    Daily patient diary cards to demonstrate whether there is a difference in the relief of nighttime heartburn between esomeprazole 20 mg once daily (E20), and placebo once daily and between esomeprazole 40 mg once daily (E40) in patients with GERD.

    Secondary Outcome Measures

    To assess the impact of treatment with E20 versus placebo and E40 versus placebo on sleep disturbances associated with GERD as measured by:Change in global PSQI score; Complete resolution of sleep disturbances; Relief of sleep disturbances; Perc
    To assess the impact of treatment with E20 versus placebo and E40 versus placebo on heartburn as measured by:Complete resolution of daytime heartburn; Complete resolution of nightime heartburn; Relief of daytime heartburn; Improvement in the fre
    To quantify the difference during 4 weeks of treatment between E20 and E40 in patients with GERD as measured by: - Relief of nightime heartburn - Relief of sleep disturbances associated with GERD

    Full Information

    First Posted
    February 26, 2008
    Last Updated
    March 11, 2009
    Sponsor
    AstraZeneca
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00628342
    Brief Title
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)
    Official Title
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2003 (undefined)
    Primary Completion Date
    August 2003 (Actual)
    Study Completion Date
    August 2003 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    AstraZeneca

    4. Oversight

    5. Study Description

    Brief Summary
    This study includes patients with sleep disturbances associated with gastroesophageal reflux disease (GERD) and has 3 treatment arms. Patients will receive only one of the following treatment arms: esomeprazole 20 mg once daily, esomeprazole 40 mg once daily, matching placebo once daily. The relief to the sleep disturbances will be assessed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Reflux Disease (GERD)
    Keywords
    Gastroesophageal Reflux Disease, GERD, Esomeprazole, Heartburn, Nexium

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Arm Title
    2
    Arm Type
    Experimental
    Arm Title
    3
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Esomeprazole
    Other Intervention Name(s)
    Nexium
    Intervention Description
    20mg Oral tablet once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Esomeprazole
    Other Intervention Name(s)
    Nexium
    Intervention Description
    40mg Oral tablet once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Oral once daily
    Primary Outcome Measure Information:
    Title
    Daily patient diary cards to demonstrate whether there is a difference in the relief of nighttime heartburn between esomeprazole 20 mg once daily (E20), and placebo once daily and between esomeprazole 40 mg once daily (E40) in patients with GERD.
    Time Frame
    Daily diary cards completed by the patients.
    Secondary Outcome Measure Information:
    Title
    To assess the impact of treatment with E20 versus placebo and E40 versus placebo on sleep disturbances associated with GERD as measured by:Change in global PSQI score; Complete resolution of sleep disturbances; Relief of sleep disturbances; Perc
    Time Frame
    Daily diary cards completed by the patients
    Title
    To assess the impact of treatment with E20 versus placebo and E40 versus placebo on heartburn as measured by:Complete resolution of daytime heartburn; Complete resolution of nightime heartburn; Relief of daytime heartburn; Improvement in the fre
    Time Frame
    Daily diary cards completed by the patients.
    Title
    To quantify the difference during 4 weeks of treatment between E20 and E40 in patients with GERD as measured by: - Relief of nightime heartburn - Relief of sleep disturbances associated with GERD
    Time Frame
    Daily diary cards completed by the patients.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: A history of heartburn or acid regurgitation for 3 months or longer or any history of erosive esophagitis. Nightime heartburn averaging at least 2 or 3 times per week and a history of sleep disturbances associated with GERD for 1 month or more. Nightime heartburn graded as moderate or severe on 3 of the last 7 days of the run-in period and sleep disturbances associated with GERD as documented in the run-in diary card on at least 3 of the last 7 days of the run-in period.. Exclusion Criteria: Any condition other than GERD that is either the primary cause of, or a significant contributor to the patients sleep disturbance. Shift workers who work between 12am (midnight) and 6am. Sleep medication, antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable for at least 3 months or is not expected to remain stable during the patients participation in the study. Other diseases / conditions as listed in the protocol.
    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

    Citations:
    PubMed Identifier
    25478944
    Citation
    Johnson DA, Le Moigne A, Hugo V, Nagy P. Rapid resolution of sleep disturbances related to frequent reflux: effect of esomeprazole 20 mg in two randomized, double-blind, controlled trials. Curr Med Res Opin. 2015 Feb;31(2):243-50. doi: 10.1185/03007995.2014.991818. Epub 2015 Jan 9.
    Results Reference
    derived

    Learn more about this trial

    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd and 40 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)

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