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

Primary Purpose

Gastroesophageal Reflux Disease

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Esomeprazole

Placebo

About this trial

This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, Esophageal Reflux, Gastro-Esophageal Reflux, Regurgitation, Gastric

Eligibility Criteria

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

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Nexium 20mg

Placebo

Arm Description

Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

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.

Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.

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.

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.

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.

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.

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.

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.

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.'

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.

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.

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).'

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.'

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.'

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.'

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.'

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)

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.

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.

Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)

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).

Full Information

NCT ID

NCT00660660

First Posted

April 15, 2008

Last Updated

February 19, 2015

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00660660

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

April 2008 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastroesophageal Reflux Disease

Keywords

GERD, Esophageal Reflux, Gastro-Esophageal Reflux, Regurgitation, Gastric

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

276 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nexium 20mg

Arm Type

Experimental

Arm Description

Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Other Intervention Name(s)

Nexium

Intervention Description

Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

once daily

Primary Outcome Measure Information:

Title

Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.

Description

Time Frame

Days 21- 28 (for early dropouts the last 7 days staying in the study)

Secondary Outcome Measure Information:

Title

Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline

Description

Time Frame

Baseline and 4 weeks

Title

Achievement of Developer-defined Good Sleep

Description

Time Frame

4 weeks

Title

Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.

Description

Time Frame

1 week

Title

Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.

Description

Time Frame

2 weeks

Title

Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.

Description

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.

Time Frame

4 weeks

Title

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.

Description

Time Frame

Days 21- 28 (for early dropouts the last 7 days staying in the study)

Title

Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment

Description

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.

Time Frame

1 week

Title

Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment

Description

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.

Time Frame

2 weeks

Title

Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment

Description

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.

Time Frame

4 weeks

Title

Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.

Description

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.

Time Frame

Days 21- 28 (for early dropouts the last 7 days staying in the study)

Title

Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period

Description

Time Frame

4 weeks

Title

Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period

Description

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.

Time Frame

4 weeks

Title

Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period

Description

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.

Time Frame

4 weeks

Title

Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period

Description

Time Frame

4 weeks

Title

Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment

Description

Time Frame

1 week

Title

Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment

Description

Time Frame

2 weeks

Title

Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment

Description

Time Frame

4 weeks

Title

Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study

Description

Time Frame

Days 21- 28 (for early dropouts the last 7 days staying in the study)

Title

Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.

Description

Time Frame

1 week

Title

Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment

Description

Time Frame

2 weeks

Title

Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment

Description

Time Frame

4 weeks

Title

Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.

Description

Time Frame

Days 21- 28 (for early dropouts the last 7 days staying in the study)

Title

Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment

Description

Time Frame

1 week

Title

Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment

Description

Time Frame

2 weeks

Title

Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment

Description

Time Frame

4 weeks

Title

Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study

Description

Time Frame

Days 21- 28 (for early dropouts the last 7 days staying in the study)

Title

Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment

Description

Time Frame

1 week

Title

Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment

Description

Time Frame

2 weeks

Title

Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment

Description

Time Frame

4 weeks

Title

Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study

Description

Time Frame

Days 21- 28 (for early dropouts the last 7 days staying in the study)

Title

Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.

Description

Time Frame

1 week

Title

Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment

Description

Time Frame

2 weeks

Title

Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment

Description

Time Frame

4 weeks

Title

Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study

Description

Time Frame

Days 21- 28 (for early dropouts the last 7 days staying in the study)

Title

Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment

Description

Time Frame

1 week

Title

Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment

Description

Time Frame

2 weeks

Title

Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment

Description

Time Frame

4 weeks

Title

Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study

Description

Time Frame

Days 21- 28 (for early dropouts the last 7 days staying in the study)

Title

Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study

Description

Time Frame

Days 21- 28 (for early dropouts the last 7 days staying in the study)

Title

Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study

Description

Time Frame

Days 21-28 (for early dropouts the last 7 days staying in the study)

Title

Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.

Description

Time Frame

Days 21- 28 (for early dropouts the last 7 days staying in the study)

Title

Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)

Time Frame

4 weeks

Title

Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)

Description

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.

Time Frame

Baseline and 4 weeks

Title

Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)

Description

Time Frame

Baseline and 4 weeks

Title

Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)

Description

Time Frame

Baseline and 4 weeks

Title

Monetary Value of Work Hours Saved

Description

Time Frame

Week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tore Lind, MD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Kurt Brown, MD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

David Johnson, MD

Organizational Affiliation

Eastern Virginia Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Huntsville

State/Province

Alabama

Country

United States

Facility Name

Research Site

City

Tucson

State/Province

Arizona

Country

United States

Facility Name

Research Site

City

Little Rock

State/Province

Arkansas

Country

United States

Facility Name

Research Site

City

Anaheim

State/Province

California

Country

United States

Facility Name

Research Site

City

Burbank

State/Province

California

Country

United States

Facility Name

Research Site

City

Castro Valley

State/Province

California

Country

United States

Facility Name

Research Site

City

Orange

State/Province

California

Country

United States

Facility Name

Research Site

City

San Diego

State/Province

California

Country

United States

Facility Name

Research Site

City

Boynton Beach

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Coral SPrings

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Deland

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Hollywood

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Jupiter

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Pembroke Pines

State/Province

Florida

Country

United States

Facility Name

Research Site

City

South Miami

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Tampa

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Zephyrhills

State/Province

Florida

Country

United States

Facility Name

Research Site

City

Stockbridge

State/Province

Georgia

Country

United States

Facility Name

Research Site

City

Overland Park

State/Province

Kansas

Country

United States

Facility Name

Research Site

City

Lexington

State/Province

Kentucky

Country

United States

Facility Name

Research Site

City

Hollywood

State/Province

Maryland

Country

United States

Facility Name

Research Site

City

Las Vegas

State/Province

Nevada

Country

United States

Facility Name

Research Site

City

Medford

State/Province

New Jersey

Country

United States

Facility Name

Research Site

City

Perth Amboy

State/Province

New Jersey

Country

United States

Facility Name

Research Site

City

West Orange

State/Province

New Jersey

Country

United States

Facility Name

Research Site

City

Albuquerque

State/Province

New Mexico

Country

United States

Facility Name

Research Site

City

Binghamton

State/Province

New York

Country

United States

Facility Name

Research Site

City

Huntersville

State/Province

North Carolina

Country

United States

Facility Name

Research Site

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

Research Site

City

Winston-Salem

State/Province

North Carolina

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

Research Site

City

Dayton

State/Province

Ohio

Country

United States

Facility Name

Research Site

City

Kettering

State/Province

Ohio

Country

United States

Facility Name

Research Site

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Research Site

City

Chattanooga

State/Province

Tennessee

Country

United States

Facility Name

Research Site

City

Johnson City

State/Province

Tennessee

Country

United States

Facility Name

Research Site

City

Amarillo

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Fort Worth Dallas

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

Research Site

City

Ogden

State/Province

Utah

Country

United States

Facility Name

Research Site

City

Burke

State/Province

Virginia

Country

United States

Facility Name

Research Site

City

Christiansburg

State/Province

Virginia

Country

United States

Facility Name

Research Site

City

Fredericksburg

State/Province

Virginia

Country

United States

Facility Name

Research Site

City

Newport News

State/Province

Virginia

Country

United States

Facility Name

Research Site

City

Bellevue

State/Province

Washington

Country

United States

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

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=437&filename=CSR-D9612L00122.pdf

Description

Related Info

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=437&filename=CSR-D9612L00122.pdf

Description

CSR-D9612L00122.pdf

Learn more about this trial

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

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

Gastroesophageal Reflux Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial