Trial Outcomes & Findings for Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US (NCT NCT00660660)

NCT ID: NCT00660660

Last Updated: 2015-03-02

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 276 participants
• Primary outcome timeframe: Days 21- 28 (for early dropouts the last 7 days staying in the study)
• Results posted on: 2015-03-02

Participant Flow

The baseline figures shown will be for the modified intention to treat population. One patient in each treatment group did not receive study drug; therefore, the safety population has one less patient in each treatment than does the randomized study population.

Participant milestones

Measure	Nexium 20 mg Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo Capsule once daily (QD)
Overall Study STARTED	143	133
Overall Study Met Criteria for MITT Population	137	125
Overall Study COMPLETED	138	124
Overall Study NOT COMPLETED	5	9

Reasons for withdrawal

Measure	Nexium 20 mg Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo Capsule once daily (QD)
Overall Study Adverse Event	1	0
Overall Study Lost to Follow-up	0	6
Overall Study Lack of Efficacy	0	2
Overall Study Withdrawal by Subject	3	0
Overall Study Incorrect enrollment and other	0	1
Overall Study New medication after randomization	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)	Total n=262 Participants Total of all reporting groups
Age, Continuous	47.0 Years STANDARD_DEVIATION 11.7 • n=5 Participants	46.8 Years STANDARD_DEVIATION 12.9 • n=7 Participants	46.9 Years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	85 Participants n=7 Participants	174 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	40 Participants n=7 Participants	88 Participants n=5 Participants

PRIMARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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).

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.	34.3 Percentage of participants	10.4 Percentage of participants

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=134 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=123 Participants Capsule once daily (QD)
Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline	-2.93 Scores on a scale Standard Deviation 0.34 • Interval 0.34 to	-1.80 Scores on a scale Standard Deviation 0.34 • Interval 0.34 to

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=21 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=29 Participants Capsule once daily (QD)
Achievement of Developer-defined Good Sleep	19 Participants	24 Participants

SECONDARY outcome

Timeframe: 1 week

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.	44 Participants	23 Participants

SECONDARY outcome

Timeframe: 2 weeks

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.	54 Participants	20 Participants

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.	29 Participants	14 Participants

SECONDARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
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.	66 Participants	27 Participants

SECONDARY outcome

Timeframe: 1 week

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment	79 Participants	53 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment	90 Participants	54 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment	74 Participants	45 Participants

SECONDARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.	71.5 Percentage of Participants	55.2 Percentage of Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.'

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=124 Participants Capsule once daily (QD)
Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period	73.0 Percentage of days Standard Deviation 29.7	59.3 Percentage of days Standard Deviation 29.9

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period	1 Days Interval 1.0 to 21.0	3 Days Interval 1.0 to 21.0

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period	1 Days Interval 1.0 to 14.0	2 Days Interval 1.0 to 21.0

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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).'

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period	9 Days Interval 1.0 to 21.0	21 Days Interval 1.0 to 21.0

SECONDARY outcome

Timeframe: 1 week

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment	22 Percentage of participants	4 Percentage of participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment	37 Percentage of participants	11 Percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment	35 Percentage of participants	7 Percentage of participants

SECONDARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study	45 Percentage of participants	9 Percentage of participants

SECONDARY outcome

Timeframe: 1 week

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.	23 Percentage of participants	4 Percentage of participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment	36 Percentage of participants	6 Percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment	25 Percentage of participants	6 Percentage of participants

SECONDARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.	42 Percentage of participants	8 Percentage of participants

SECONDARY outcome

Timeframe: 1 week

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment	16 Percentage of participants	3 Percentage of participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment	30 Percentage of participants	4 Percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment	30 Percentage of participants	4 Percentage of participants

SECONDARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study	37 Percentage of participants	5 Percentage of participants

SECONDARY outcome

Timeframe: 1 week

Population: Results based on MITT population with available data for this outcome measure.

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.'

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment	34 Percentage of participants	13 Percentage of participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.'

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment	48 Percentage of participants	14 Percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.'

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment	40 Percentage of participants	9 Percentage of participants

SECONDARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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.'

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study	55 Percentage of participants	14 Percentage of participants

SECONDARY outcome

Timeframe: 1 week

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.	28 Percentage of participants	9 Percentage of participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment	40 Percentage of participants	7 Percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment	26 Percentage of participants	6 Percentage of participants

SECONDARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study	47 Percentage of participants	13 Percentage of participants

SECONDARY outcome

Timeframe: 1 week

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment	27 Percentage of participants	5 Percentage of participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment	36 Percentage of participants	5 Percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment	33 Percentage of participants	5 Percentage of participants

SECONDARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study	45 Percentage of participants	9 Percentage of participants

SECONDARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study	89.8 Percentage of participants	83.2 Percentage of participants

SECONDARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=137 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=125 Participants Capsule once daily (QD)
Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study	86.1 Percentage of participants	76 Percentage of participants

SECONDARY outcome

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

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=125 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=137 Participants Capsule once daily (QD)
Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.	89.8 Percentage of participants	80 Percentage of participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

Outcome measures

Measure	Nexium 20 mg n=78 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=74 Participants Capsule once daily (QD)
Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)	8.9 Work hours Standard Deviation 11.1	5.2 Work hours Standard Deviation 11.7

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=83 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=78 Participants Capsule once daily (QD)
Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)	-25.3 Percentage Standard Deviation 28.7	-14 Percentage Standard Deviation 27.4

SECONDARY outcome

Timeframe: Baseline and 4 weeks

Population: Results based on MITT population with available data for this outcome measure.

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.

Outcome measures

Measure	Nexium 20 mg n=76 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=74 Participants Capsule once daily (QD)
Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)	-24.8 Percentage Standard Deviation 29.5	-14.9 Percentage Standard Deviation 25.9

SECONDARY outcome

Timeframe: Baseline and 4 weeks

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.

Outcome measures

Measure	Nexium 20 mg n=87 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=78 Participants Capsule once daily (QD)
Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)	-25.1 Percentage Standard Deviation 27.4	-17.1 Percentage Standard Deviation 28

SECONDARY outcome

Timeframe: Week 4

Population: Results based on MITT population with available data for this outcome measure.

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).

Outcome measures

Measure	Nexium 20 mg n=76 Participants Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=74 Participants Capsule once daily (QD)
Monetary Value of Work Hours Saved	280.21 Monetary value (US dollars) Standard Deviation 34.88 • Interval 34.88 to 0.0	156.61 Monetary value (US dollars) Standard Deviation 33.05 • Interval 33.05 to 0.0

Adverse Events

Nexium 20 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nexium 20 mg n=143 participants at risk Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Placebo n=133 participants at risk Capsule once daily (QD)
Infections and infestations Pneumonia	0.00% 0/143	0.75% 1/133

Other adverse events

Adverse event data not reported

Additional Information

Clinical Trial Transparency

AstraZeneca

Email: ClinicalTrialTransparency@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee If Sponsor does not publish within 2 years after study completion, PI is permitted to publish, with confidential information removed from manuscript. Sponsor will have opportunity to review and approve publication at least 60 days prior to being submitted/disclosed. Sponsor can request, in writing, an additional 90 day embargo.
• Publication restrictions are in place

Restriction type: OTHER