Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT00660660
Status:
COMPLETED
Last Update Posted:
2015-03-02
First Post:
2008-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Clinical Trial Transparency', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate', 'otherNumAtRisk': 143, 'otherNumAffected': 0, 'seriousNumAtRisk': 143, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)', 'otherNumAtRisk': 133, 'otherNumAffected': 0, 'seriousNumAtRisk': 133, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 133, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '34.3', 'groupId': 'OG000'}, {'value': '10.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.93', 'spread': '0.34', 'groupId': 'OG000', 'lowerLimit': '0.3400'}, {'value': '-1.80', 'spread': '0.34', 'groupId': 'OG001', 'lowerLimit': '0.3400'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': '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.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Achievement of Developer-defined Good Sleep', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', '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)?". Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of "No" on 7 consecutive days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', '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)?". Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of "No" on 14 consecutive days.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', '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.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': "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.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', '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.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '71.5', 'groupId': 'OG000'}, {'value': '55.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying 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.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '73.0', 'spread': '29.7', 'groupId': 'OG000'}, {'value': '59.3', 'spread': '29.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'description': '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.\'', 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '21'}, {'value': '3', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', '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.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '14'}, {'value': '2', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', '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.', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '21'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '21'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '4 weeks', 'description': '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).\'', 'unitOfMeasure': 'Days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study", 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': '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. 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Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.", 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': '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. 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Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': '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. 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Complete resolution of daytime, nighttime, and 24-hour heartburn was defined as a daily diary response of "None" on 7 consecutive days.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': '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.\'', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': '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. 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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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study", 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 week', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 weeks', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '4 weeks', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': "Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study", 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '89.8', 'groupId': 'OG000'}, {'value': '83.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '86.1', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21-28 (for early dropouts the last 7 days staying in the study)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '89.8', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '78', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '11.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks', 'unitOfMeasure': 'Work hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.3', 'spread': '28.7', 'groupId': 'OG000'}, {'value': '-14', 'spread': '27.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', '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.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '-24.8', 'spread': '29.5', 'groupId': 'OG000'}, {'value': '-14.9', 'spread': '25.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': '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.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.1', 'spread': '27.4', 'groupId': 'OG000'}, {'value': '-17.1', 'spread': '28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 4 weeks', 'description': '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.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Monetary Value of Work Hours Saved', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'classes': [{'categories': [{'measurements': [{'value': '280.21', 'spread': '34.88', 'groupId': 'OG000', 'lowerLimit': '34.8800', 'upperLimit': '0.0000'}, {'value': '156.61', 'spread': '33.05', 'groupId': 'OG001', 'lowerLimit': '33.05', 'upperLimit': '0.0000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 4', 'description': '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).', 'unitOfMeasure': 'Monetary value (US dollars)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Results based on MITT population with available data for this outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Randomized', 'groupId': 'FG000', 'numSubjects': '143'}, {'comment': 'Randomized', 'groupId': 'FG001', 'numSubjects': '133'}]}, {'type': 'Met Criteria for MITT Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Number of completed patients is based on randomized population (143) minus withdrawals (5).', 'groupId': 'FG000', 'numSubjects': '138'}, {'comment': 'Number of completed patients is based on randomized population (133) minus withdrawals (9).', 'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Incorrect enrollment and other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'New medication after randomization', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The baseline figures shown will be for the modified intention to treat population.\n\nOne 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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nexium 20 mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Capsule once daily (QD)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.0', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '46.8', 'spread': '12.9', 'groupId': 'BG001'}, {'value': '46.9', 'spread': '12.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '89', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 276}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-19', 'studyFirstSubmitDate': '2008-04-15', 'resultsFirstSubmitDate': '2009-06-12', 'studyFirstSubmitQcDate': '2008-04-16', 'lastUpdatePostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-02-19', 'studyFirstPostDateStruct': {'date': '2008-04-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Relief of Nighttime Heartburn During the Last 7 Days of the Study.', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Change in Mean (Average) Pittsburgh Sleep Quality Index (PSQI) Scores From Baseline', 'timeFrame': 'Baseline and 4 weeks', 'description': '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.'}, {'measure': 'Achievement of Developer-defined Good Sleep', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': 'Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment.', 'timeFrame': '1 week', '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)?". Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of "No" on 7 consecutive days.'}, {'measure': 'Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment.', 'timeFrame': '2 weeks', '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)?". Complete resolution of GERD-related sleep disturbances was defined as a daily diary response of "No" on 14 consecutive days.'}, {'measure': 'Number of Patients With Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment.', 'timeFrame': '4 weeks', '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.'}, {'measure': "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.", 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': "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."}, {'measure': 'Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 1 Week of Treatment', 'timeFrame': '1 week', '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.'}, {'measure': 'Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 2 Weeks of Treatment', 'timeFrame': '2 weeks', '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.'}, {'measure': 'Number of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) After 4 Weeks of Treatment', 'timeFrame': '4 weeks', '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.'}, {'measure': "Percentage of Patients With Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) on the Patient's Last 7 Days in the Study.", 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying 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.'}, {'measure': 'Percentage of Days Without Gastroesophageal Reflux Disease (GERD)-Related Sleep Disturbances During the 4 Week Period', 'timeFrame': '4 weeks', 'description': '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.\''}, {'measure': 'Number of Days to First Relief of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period', 'timeFrame': '4 weeks', '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.'}, {'measure': 'Number of Days to Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period', 'timeFrame': '4 weeks', '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.'}, {'measure': 'Number of Days to First Complete Resolution of Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD) During the 4 Week Treatment Period', 'timeFrame': '4 weeks', 'description': '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).\''}, {'measure': 'Percentage of Patients With Complete Resolution of Daytime Heartburn After 1 Week of Treatment', 'timeFrame': '1 week', 'description': '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.'}, {'measure': 'Percentage of Patients With Complete Resolution of Daytime Heartburn After 2 Weeks of Treatment', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Percentage of Patients With Complete Resolution of Daytime Heartburn After 4 Weeks of Treatment', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': "Percentage of Patients With Complete Resolution of Daytime Heartburn on the Patient's Last 7 Days in the Study", 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.'}, {'measure': 'Percentage of Patients With Complete Resolution of Nighttime Heartburn After 1 Week of Treatment.', 'timeFrame': '1 week', 'description': '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.'}, {'measure': 'Percentage of Patients With Complete Resolution of Nighttime Heartburn After 2 Weeks of Treatment', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Percentage of Patients With Complete Resolution of Nighttime Heartburn After 4 Weeks of Treatment', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': "Percentage of Patients With Complete Resolution of Nighttime Heartburn on the Patient's Last 7 Days in the Study.", 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.'}, {'measure': 'Percentage of Patients With Complete Resolution of 24-hour Heartburn After 1 Week of Treatment', 'timeFrame': '1 week', 'description': '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.'}, {'measure': 'Percentage of Patients With Complete Resolution of 24-hour Heartburn After 2 Weeks of Treatment', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Percentage of Patients With Complete Resolution of 24-hour Heartburn After 4 Weeks of Treatment', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': "Percentage of Patients With Complete Resolution of 24-hour Heartburn on the Patient's Last 7 Days in the Study", 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.'}, {'measure': 'Percentage of Patients With Relief of Daytime Heartburn After 1 Week of Treatment', 'timeFrame': '1 week', 'description': '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.\''}, {'measure': 'Percentage of Patients With Relief of Daytime Heartburn After 2 Weeks of Treatment', 'timeFrame': '2 weeks', 'description': '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.\''}, {'measure': 'Percentage of Patients With Relief of Daytime Heartburn After 4 Weeks of Treatment', 'timeFrame': '4 weeks', 'description': '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.\''}, {'measure': "Percentage of Patients With Relief of Daytime Heartburn on the Patient's Last 7 Days in the Study", 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.\''}, {'measure': 'Percentage of Patients With Relief of Nighttime Heartburn After 1 Week of Treatment.', 'timeFrame': '1 week', 'description': '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.'}, {'measure': 'Percentage of Patients With Relief of Nighttime Heartburn After 2 Weeks of Treatment', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Percentage of Patients With Relief of Nighttime Heartburn After 4 Weeks of Treatment', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': "Percentage of Patients With Relief of Nighttime Heartburn on the Patient's Last 7 Days in the Study", 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.'}, {'measure': 'Percentage of Patients With Relief of 24-hour Heartburn After 1 Week of Treatment', 'timeFrame': '1 week', 'description': '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.'}, {'measure': 'Percentage of Patients With Relief of 24-hour Heartburn After 2 Weeks of Treatment', 'timeFrame': '2 weeks', 'description': '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.'}, {'measure': 'Percentage of Patients With Relief of 24-hour Heartburn After 4 Weeks of Treatment', 'timeFrame': '4 weeks', 'description': '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.'}, {'measure': "Percentage of Patients With Relief of 24-hour Heartburn on the Patient's Last 7 Days in the Study", 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.'}, {'measure': 'Percentage of Patients With Nighttime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.'}, {'measure': 'Percentage of Participants With Daytime Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study', 'timeFrame': 'Days 21-28 (for early dropouts the last 7 days staying in the study)', 'description': '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.'}, {'measure': 'Percentage of Patients With 24-hour Heartburn Symptom Improvement From Baseline During the Last 7 Days in the Study.', 'timeFrame': 'Days 21- 28 (for early dropouts the last 7 days staying in the study)', 'description': '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.'}, {'measure': 'Equivalent Number of Hours Lost Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)', 'timeFrame': '4 weeks'}, {'measure': 'Change From Baseline in Percent of Work Impairment Because of Sleep Disturbances Due to Gastroesophageal Reflux Disease (GERD) Symptoms (Average)', 'timeFrame': 'Baseline and 4 weeks', '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.'}, {'measure': 'Change From Baseline in Percent Overall Work Impairment Due to Sleep Disturbance (Average)', 'timeFrame': 'Baseline and 4 weeks', 'description': '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.'}, {'measure': 'Change From Baseline in Percent Activity Impairment Due to Sleep Disturbances (Average)', 'timeFrame': 'Baseline and 4 weeks', 'description': '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.'}, {'measure': 'Monetary Value of Work Hours Saved', 'timeFrame': 'Week 4', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD', 'Esophageal Reflux', 'Gastro-Esophageal Reflux', 'Regurgitation', 'Gastric'], 'conditions': ['Gastroesophageal Reflux Disease']}, 'referencesModule': {'references': [{'pmid': '25478944', 'type': 'DERIVED', '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.'}], 'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=437&filename=CSR-D9612L00122.pdf', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=437&filename=CSR-D9612L00122.pdf', 'label': 'CSR-D9612L00122.pdf'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Prior to the run-in period, a history of heartburn or acid regurgitation for 3 months or longer or any history of EE;\n* Prior to the run-in period, nighttime heartburn averaging at least 2 or 3 times per week;\n* Prior to the run-in period, a history of sleep disturbances associated with GERD for 1 month or more;\n\nExclusion Criteria:\n\n* Any condition other than GERD that is either the primary cause of, or a significant contributor to, the patient's sleep disturbance\n* 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;\n* 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"}, 'identificationModule': {'nctId': 'NCT00660660', 'briefTitle': 'Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'D9612L00122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nexium 20mg', 'description': 'Nexium 20 mg administered once daily as 22.3 mg of esomeprazole magnesium hydrate', 'interventionNames': ['Drug: Esomeprazole']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': 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