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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

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).

Local Phase IV, gastroesophageal reflux disease (GERD) Sleep Study US

Research Site

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)

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).

Age Continuous

Gender, Male/Female

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

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

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.

Change in mean (average) Pittsburgh Sleep Quality index (PSQI) scores from Baseline

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.

Achievement of developer-defined good sleep

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 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 14 consecutive days.

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 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) after 4 weeks of treatment.

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 complete resolution 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.

Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 1 week of treatment

Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) after 2 weeks of treatment

Number of patients with relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD)  after 4 weeks of treatment

Percentage of patients with relief 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: 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.'

Percentage of days without Gastroesophageal Reflux Disease (GERD)-related sleep disturbances during the 4 week 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 first relief of sleep disturbances associated with Gastroesophageal Reflux Disease (GERD) during the 4 week treatment period

Number of days to 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).'

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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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. 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 on the patient's 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 Patients With Nighttime 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 Participants With Daytime 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.

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

Equivalent Number of hours lost 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 of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (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 Overall Work Impairment Due to Sleep Disturbance (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.

Change from Baseline in Percent Activity Impairment Due to Sleep Disturbances (average)

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).

Monetary value of work hours saved

Overall Study

Clinical Trial Transparency

Degree of sleep disturbance affecting work productivity.

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).

Arms	Assigned Interventions
Experimental: Nexium 20mg Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate	Drug: Esomeprazole Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate Other Name: Nexium
Placebo Comparator: Placebo	Drug: Placebo once daily

Local Phase IV, gastroesophageal reflux disease (GERD) Sleep Study US

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

CSR-D9612L00122.pdf

Trial Results Summaries

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