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

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)

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).

Study Overview

• Status: Completed
• Conditions: Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: Placebo; Drug: Esomeprazole

• Study Type: Interventional
• Enrollment (Actual): 276
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States
      • Research Site
  • Arizona
    • Tucson, Arizona, United States
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States
      • Research Site
  • California
    • Anaheim, California, United States
      • Research Site
    • Burbank, California, United States
      • Research Site
    • Castro Valley, California, United States
      • Research Site
    • Orange, California, United States
      • Research Site
    • San Diego, California, United States
      • Research Site
  • Florida
    • Boynton Beach, Florida, United States
      • Research Site
    • Coral SPrings, Florida, United States
      • Research Site
    • Deland, Florida, United States
      • Research Site
    • Hollywood, Florida, United States
      • Research Site
    • Jupiter, Florida, United States
      • Research Site
    • Pembroke Pines, Florida, United States
      • Research Site
    • South Miami, Florida, United States
      • Research Site
    • Tampa, Florida, United States
      • Research Site
    • Zephyrhills, Florida, United States
      • Research Site
  • Georgia
    • Stockbridge, Georgia, United States
      • Research Site
  • Kansas
    • Overland Park, Kansas, United States
      • Research Site
  • Kentucky
    • Lexington, Kentucky, United States
      • Research Site
  • Maryland
    • Hollywood, Maryland, United States
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States
      • Research Site
  • New Jersey
    • Medford, New Jersey, United States
      • Research Site
    • Perth Amboy, New Jersey, United States
      • Research Site
    • West Orange, New Jersey, United States
      • Research Site
  • New Mexico
    • Albuquerque, New Mexico, United States
      • Research Site
  • New York
    • Binghamton, New York, United States
      • Research Site
  • North Carolina
    • Huntersville, North Carolina, United States
      • Research Site
    • Raleigh, North Carolina, United States
      • Research Site
    • Winston-Salem, North Carolina, United States
      • Research Site
  • Ohio
    • Cincinnati, Ohio, United States
      • Research Site
    • Dayton, Ohio, United States
      • Research Site
    • Kettering, Ohio, United States
      • Research Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Research Site
  • Tennessee
    • Chattanooga, Tennessee, United States
      • Research Site
    • Johnson City, Tennessee, United States
      • Research Site
  • Texas
    • Amarillo, Texas, United States
      • Research Site
    • Fort Worth Dallas, Texas, United States
      • Research Site
    • Houston, Texas, United States
      • Research Site
  • Utah
    • Ogden, Utah, United States
      • Research Site
  • Virginia
    • Burke, Virginia, United States
      • Research Site
    • Christiansburg, Virginia, United States
      • Research Site
    • Fredericksburg, Virginia, United States
      • Research Site
    • Newport News, Virginia, United States
      • Research Site
  • Washington
    • Bellevue, Washington, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; once daily
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 Names: Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.	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).	Days 21- 28 (for early dropouts the last 7 days staying in the study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline	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.	Baseline and 4 weeks
Achievement of Developer-defined Good Sleep	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.	4 weeks
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.	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.	1 week
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.	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.	2 weeks
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.	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.	4 weeks
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.	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.	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment	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.	1 week
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment	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.	2 weeks
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment	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.	4 weeks
Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.	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.	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period	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.'	4 weeks
Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period	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.	4 weeks
Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period	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.	4 weeks
Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period	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).'	4 weeks
Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment	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.	1 week
Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment	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.	2 weeks
Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment	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.	4 weeks
Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study	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.	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.	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.	1 week
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment	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.	2 weeks
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment	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.	4 weeks
Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.	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.	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment	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.	1 week
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment	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.	2 weeks
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment	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.	4 weeks
Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study	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.	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment	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.'	1 week
Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment	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.'	2 weeks
Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment	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.'	4 weeks
Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study	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.'	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.	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.	1 week
Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment	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.	2 weeks
Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment	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.	4 weeks
Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study	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.	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment	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.	1 week
Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment	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.	2 weeks
Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment	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.	4 weeks
Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study	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.	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study	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.	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study	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.	Days 21-28 (for early dropouts the last 7 days staying in the study)
Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.	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.	Days 21- 28 (for early dropouts the last 7 days staying in the study)
Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)		4 weeks
Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)	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.	Baseline and 4 weeks
Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)	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.	Baseline and 4 weeks
Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)	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.	Baseline and 4 weeks
Monetary Value of Work Hours Saved	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).	Week 4

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Kurt Brown, MD, AstraZeneca; Principal Investigator: David Johnson, MD, Eastern Virginia Medical School

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info
• CSR-D9612L00122.pdf

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): July 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: April 15, 2008
• First Submitted That Met QC Criteria: April 16, 2008
• First Posted (Estimate): April 17, 2008

Study Record Updates

• Last Update Posted (Estimate): March 2, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: GERD; Regurgitation; Gastric; Esophageal Reflux; Gastro-Esophageal Reflux
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Intestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Esophagitis; Peptic Ulcer; Duodenal Diseases; Gastroesophageal Reflux; Esophagitis, Peptic; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: D9612L00122