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

Gastroesophageal Reflux Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660660
• Other study ID #: D9612L00122
• Status: Completed
• Phase: Phase 4
• First received: April 15, 2008
• Last updated: February 19, 2015
• Start date: April 2008
• Est. completion date: July 2008

Study information

• Verified date: February 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

Drug:
• Esomeprazole
Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate
• Placebo
once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)		4 weeks	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   Link
•   CSR-D9612L00122.pdf