Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00660660
First received: April 15, 2008
Last updated: February 19, 2015
Last verified: February 2015
  Purpose

The purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: Esomeprazole
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study. [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    Relief of nighttime heartburn on patient's last 7 days in the study. Relief was defined as a daily diary card response of "none" or 0, on at least 6 of 7 days, allowing for one "mild" or 1 response. Diary card scale (none, mild, moderate, severe).


Secondary Outcome Measures:
  • Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, "no difficulty" to 3, "severe difficulty." Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.

  • Achievement of Developer-defined Good Sleep [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal reflux disease (GERD), as measured by achievement of (yes/no) developer-defined good sleep (global Pittsburgh Sleep Quality Index - PSQI score ≤5) at Week 4.

  • Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of "No" on 7 consecutive days.

  • Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of "No" on 14 consecutive days.

  • Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?". Complete resolution of Gastroesophageal Reflux Disease (GERD)-related sleep disturbances was defined as a daily diary response of "No" on 7 consecutive days during 4 weeks of treatment.

  • Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study. [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Complete resolution of sleep disturbances on the patient's last 7 days in the study.

  • Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days.

  • Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days.

  • Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days.

  • Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study. [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days.

  • Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD)as measured by: Percent of days without sleep disturbances after 4 weeks of treatment. Each morning of the study, patients registered their answer "Yes" or "No" to the question, "Did you have trouble sleeping last night due to your heartburn or other symptoms of GERD?" in the diary card.'

  • Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days, and 'days to first relief' was defined as the first day of the 7 days that reached relief of sleep disturbance.

  • Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The assessment was based on patients registrations of the answers "Yes" or "No" to the question: "Did you have trouble sleeping last night due to your heartburn or other symptoms of Gastroesophageal Reflux Disease (GERD)?". Relief of sleep disturbances associated with GERD was defined as a daily diary response of "Yes" on not more than 2 of 7 consecutive days.

  • Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on sleep disturbances associated with Gastroesophageal Reflux Disease (GERD), as measured by: Days to complete resolution of sleep disturbance. Days to complete resolution of sleep disturbances associated with GERD was defined as the number of days until the first day of the first 7‑consecutive-day period during which the patient's daily diary response was "No" (did not have trouble sleeping due to GERD symptoms).'

  • Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 1 week of treatment. Results based on MITT population with available data for this outcome measure. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of daytime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study. [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of nighttime heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 1 week of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 2 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn after 4 weeks of treatment. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Complete resolution of 24-hour heartburn on the patient's last 7 days in the study. Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.

  • Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Results based on MITT population with available data for this outcome measure. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.'

  • Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.'

  • Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.'

  • Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of daytime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.'

  • Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.

  • Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.

  • Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.

  • Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of nighttime heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.

  • Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 1 week of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.

  • Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 2 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.

  • Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn after 4 weeks of treatment. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.

  • Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    To assess the impact of treatment with Esomeprazole 20 (E20) versus placebo on heartburn, as measured by: Relief of 24-hour heartburn on the patient's last 7 days in the study. Relief of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "none" on at least 6 of 7 days, allowing for 1 "mild" response.

  • Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    Number and percentage of patients with nighttime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.

  • Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study [ Time Frame: Days 21-28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    Number of patients with daytime heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.

  • Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study. [ Time Frame: Days 21- 28 (for early dropouts the last 7 days staying in the study) ] [ Designated as safety issue: No ]
    Number of patients with 24-hour heartburn symptom improvement based on weekly symptom scores at Baseline compared to the last week of study drug treatment. Symptom improvement was defined as any decrease in weekly symptom score from Baseline until the last 7 days in the study.

  • Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    Degree of sleep disturbance affecting work productivity. 100% is considered to be the worst outcome where there is no ability to work. 0% is considered to be the best outcome, no impairment.

  • Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    Equivalent number of work hours missed was derived from questions 2, 4 and 5 of the Work Productivity and Activity Impairment Questionnaire: Sleep Disturbance-GERD (Gastroesophageal Reflux Disease) and summed up with the percent work impairment during the remaining hours that were actually worked.

  • Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average) [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    To assess the impact of treatment as measured by: Change in global Pittsburgh Sleep Quality Index (PSQI) scores from baseline to week 4. Scale details -'Scoring ranged from 0, "no difficulty" to 3, "severe difficulty." Items were grouped into 7 component scores. The 7 components were then summed to yield a global PSQI score. Global scores >5 were considered to meet the criteria of sleep disturbance.

  • Monetary Value of Work Hours Saved [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    The monetary value of the work hours saved was derived from questions 2,4, and 5 of the WPAI and a standard hourly compensation rate reported by the US Bureau of Labor Statistics (US$28.48 as of June 2008).


Enrollment: 276
Study Start Date: April 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nexium 20mg
Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Drug: Esomeprazole
Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
Other Name: Nexium
Placebo Comparator: Placebo Drug: Placebo
once daily

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Prior to the run-in period, a history of heartburn or acid regurgitation for 3 months or longer or any history of EE;
  • Prior to the run-in period, nighttime heartburn averaging at least 2 or 3 times per week;
  • Prior to the run-in period, a history of sleep disturbances associated with GERD for 1 month or more;

Exclusion Criteria:

  • Any condition other than GERD that is either the primary cause of, or a significant contributor to, the patient's sleep disturbance
  • Sleep medication (including over-the-counter), antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable (either in dose or regularity) for at least 3 months or is not expected to remain stable during the patient's participation in the study. Patients on a stable regimen, whose regimen is also expected to remain stable throughout the study, are eligible for participation;
  • Proton Pump Inhibitor (PPI) use within 1 week prior to Screening. The only allowable acid modifying rescue medication is GELUSIL® during the run-in period. Only study medication and rescue medication (GELUSIL®) is allowed during the treatment period for treatment of acid mediated symptoms
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660660

  Show 45 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Tore Lind, MD AstraZeneca
Study Director: Kurt Brown, MD AstraZeneca
Principal Investigator: David Johnson, MD Eastern Virginia Medical School
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00660660     History of Changes
Other Study ID Numbers: D9612L00122
Study First Received: April 15, 2008
Results First Received: June 12, 2009
Last Updated: February 19, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
GERD
Esophageal Reflux
Gastro-Esophageal Reflux
Regurgitation
Gastric

Additional relevant MeSH terms:
Gastroesophageal Reflux
Deglutition Disorders
Digestive System Diseases
Esophageal Diseases
Esophageal Motility Disorders
Gastrointestinal Diseases
Esomeprazole
Anti-Ulcer Agents
Enzyme Inhibitors
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Proton Pump Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015