Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-29 @ 1:46 PM
Study NCT ID:
NCT01119768
Status:
COMPLETED
Last Update Posted:
2012-09-28
First Post:
2010-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096663', 'term': 'Non-Erosive Reflux Disease'}], 'ancestors': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'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': 'az_trials_posting@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline to 24 weeks after treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks', 'otherNumAtRisk': 154, 'otherNumAffected': 0, 'seriousNumAtRisk': 154, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks', 'otherNumAtRisk': 151, 'otherNumAffected': 0, 'seriousNumAtRisk': 151, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks'}, {'id': 'OG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '94.9', 'groupId': 'OG000'}, {'value': '87.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks', 'description': 'GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment'}, {'type': 'SECONDARY', 'title': 'The Success Rate in Whole Study Duration.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks'}, {'id': 'OG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '83.8', 'groupId': 'OG000'}, {'value': '72.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after end of treatment', 'description': 'Success is defined as patients with symptom relief after 8 weeks or 2 weeks esomeprazole treatment, and also get symptom controlled during maintenance treatment / follow-up period.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intension to Treat (ITT) was defined as all randomized subjects who took at least one dose of treatment.'}, {'type': 'SECONDARY', 'title': 'Time to First Relapse.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks'}, {'id': 'OG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'More than half of patients remained relapse free.', 'groupId': 'OG000', 'lowerLimit': '35', 'upperLimit': 'NA'}, {'value': '57', 'groupId': 'OG001', 'lowerLimit': '12', 'upperLimit': '174'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to 24 weeks after end of treatment', 'description': 'Time to first relapse is from the last dose during the treatment period to date of first time patient comes to the investigator due to symptom recure and need for treatment.\n\nTime to first relapse is actually the time when 50% of patients had relapse. Up to the end of study, there were less than 50% of the patients in arm esomeprazole 2 weeks group had relapse so was unable to compute this endpoint', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.'}, {'type': 'SECONDARY', 'title': 'Symptom Relief Rate in 2 Treatment Regimens.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '151', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks'}, {'id': 'OG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000'}, {'value': '83.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks for arm 1, 2 weeks for arm 2', 'description': 'Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.', 'unitOfMeasure': 'percentage of participans', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT was defined as all randomized subjects who took at least one dose of treatment.'}, {'type': 'SECONDARY', 'title': 'Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks'}, {'id': 'OG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks'}], 'classes': [{'title': '2 weeks', 'categories': [{'measurements': [{'value': '54.5', 'groupId': 'OG000'}]}]}, {'title': '8 weeks', 'categories': [{'measurements': [{'value': '88.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '2 and 8 weeks', 'description': 'Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT in 8 weeks treatment group'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Unscheduled Hospital Visit(s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks'}, {'id': 'OG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from baseline to week 24 after end of treatment', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks'}, {'id': 'OG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks'}], 'classes': [{'title': 'Satisfied', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '96', 'groupId': 'OG001'}]}]}, {'title': 'Very satisfied', 'categories': [{'measurements': [{'value': '48.5', 'groupId': 'OG000'}, {'value': '24.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '24 weeks after end of treatment', 'description': 'Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks'}, {'id': 'OG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '80.1', 'groupId': 'OG000'}, {'value': '75.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intension To Treat defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment'}, {'type': 'SECONDARY', 'title': 'Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks'}, {'id': 'OG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '85.3', 'groupId': 'OG000'}, {'value': '80.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks', 'description': 'GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT was defined as patients in ITT population with symptom relief after 8 weeks or 2 weeks esomeprazole treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks'}, {'id': 'FG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '154'}, {'groupId': 'FG001', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '126'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '25'}]}]}, {'title': 'Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '136'}, {'groupId': 'FG001', 'numSubjects': '124'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '135'}, {'groupId': 'FG001', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Three hundred and five patients, out of the 311 patients who signed the informed consent, were randomized to receive 8 weeks (n=154) or 2 weeks (n=151) of esomeprazole treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Esomeprazole 8 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks'}, {'id': 'BG001', 'title': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '283', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'spread': '12.72', 'groupId': 'BG000'}, {'value': '44.9', 'spread': '13.12', 'groupId': 'BG001'}, {'value': '45.4', 'spread': '12.91', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '171', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '154', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '305', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 305}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-26', 'studyFirstSubmitDate': '2010-04-27', 'resultsFirstSubmitDate': '2012-06-01', 'studyFirstSubmitQcDate': '2010-05-07', 'lastUpdatePostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-26', 'studyFirstPostDateStruct': {'date': '2010-05-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Control Rate at 24 Weeks Assessed by Gerd Q Questionnaire.', 'timeFrame': '24 weeks', 'description': 'GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.'}], 'secondaryOutcomes': [{'measure': 'The Success Rate in Whole Study Duration.', 'timeFrame': '24 weeks after end of treatment', 'description': 'Success is defined as patients with symptom relief after 8 weeks or 2 weeks esomeprazole treatment, and also get symptom controlled during maintenance treatment / follow-up period.'}, {'measure': 'Time to First Relapse.', 'timeFrame': 'From baseline to 24 weeks after end of treatment', 'description': 'Time to first relapse is from the last dose during the treatment period to date of first time patient comes to the investigator due to symptom recure and need for treatment.\n\nTime to first relapse is actually the time when 50% of patients had relapse. Up to the end of study, there were less than 50% of the patients in arm esomeprazole 2 weeks group had relapse so was unable to compute this endpoint'}, {'measure': 'Symptom Relief Rate in 2 Treatment Regimens.', 'timeFrame': '8 weeks for arm 1, 2 weeks for arm 2', 'description': 'Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.'}, {'measure': 'Symptom Relief Rate After 2 Weeks and 8 Weeks in 8 Weeks Treatment Group.', 'timeFrame': '2 and 8 weeks', 'description': 'Symptom relief is defined as no more than 1 day of mild symptoms of GERD during previous 7 days after 8 weeks or 2 weeks of treatment.'}, {'measure': 'Number of Patients With Unscheduled Hospital Visit(s)', 'timeFrame': 'from baseline to week 24 after end of treatment'}, {'measure': 'Percentage of Patients Satisfaction', 'timeFrame': '24 weeks after end of treatment', 'description': 'Satisfied - satisfaction score of 1-4 while very satisfied - satisfaction score of 1-2.'}, {'measure': 'Symptom Control Rate at 8 Weeks Assessed by Gerd Q Questionnaire', 'timeFrame': '8 weeks', 'description': 'GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.'}, {'measure': 'Symptom Control Rate at 16 Weeks Assessed by Gerd Q Questionnaire', 'timeFrame': '16 weeks', 'description': 'GerdQ Scores ranging from 0 to 3 were applied for the positive predictors and from 3 to 0 (reversed order, where 3 = none) for negative predictors. The GerdQ score was calculated as the sum of these scores, giving a total score ranging from 0 to 18. When GerdQ ≥8, the patients could be symptom based diagnosed as GERD. GerdQ was consisted of 3 categories: A, B and C. Each category has two questions with sum of score ranging from 0 to 6. Symptom controlled was defined as patients with all items ≤1 in A and C category of GerdQ.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GI', 'Nexium', 'Phase IV', 'Co-diagnosed NERD'], 'conditions': ['Non Erosive Reflux Disease', 'Chronic Gastritis']}, 'descriptionModule': {'briefSummary': 'To compare the symptom control rate between 8 weeks esomeprazole treatment regimen group and 2 weeks esomeprazole treatment regimen group in co-diagnosed NERD and chronic gastritis patients, as evaluated by GerdQ after 24 weeks maintenance treatment/follow up.', 'detailedDescription': 'A multicenter, randomized, open-label Phase IV study exploring symptom control rate in co-diagnosed NERD and chronic gastritis patients treated with 8 weeks esomeprazole treatment regimen and 2 weeks esomeprazole treatment regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Heartburn and/or regurgitation symptoms last for at least 3 months\n* Endoscopic diagnosed as chronic gastritis (non-atrophic, and mild atrophic gastritis) within 2 weeks prior to randomization GerdQ score =8\n\nExclusion Criteria:\n\n* Endoscopic visible reflux esophagitis, esophageal varices, Barrett's esophagus, malignancy or peptic ulcer Patients with Hp positive result and are eager to take Hp eradication therapy will be excluded\n* If Hp positive, patients could take Hp eradication therapy after the study completion Previous PPI or H2RA therapy in the last 2 weeks before enrollment"}, 'identificationModule': {'nctId': 'NCT01119768', 'briefTitle': 'Esomeprazole Treatment Co-diagnosed Non Erosive Reflux Disease (NERD) and Chronic Gastritis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Multicenter, Randomized, Open-label Phase IV Study Exploring Symptom Control Rate in Co-diagnosed NERD and Chronic Gastritis Patients Treated With 8 Weeks Esomeprazole Treatment Regimen and 2 Weeks Esomeprazole Treatment Regimen', 'orgStudyIdInfo': {'id': 'D9612L00127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Esomeprazole 8 weeks treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 8 weeks', 'interventionNames': ['Drug: Esomeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Esomeprazole 2 Weeks Treatment', 'description': '20 mg q.d. (quaque die) once a day dosing for 2 weeks', 'interventionNames': ['Drug: Esomeprazole']}], 'interventions': [{'name': 'Esomeprazole', 'type': 'DRUG', 'description': '20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment', 'armGroupLabels': ['Esomeprazole 8 weeks treatment']}, {'name': 'Esomeprazole', 'type': 'DRUG', 'description': '20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up', 'armGroupLabels': ['Esomeprazole 2 Weeks Treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}, {'city': 'Xian', 'state': 'Shanxi', 'country': 'China', 'facility': 'Research Site'}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Beijin', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 35.93305, 'lon': 111.40836}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Wenyu Guo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca China MC'}, {'name': 'Prof. Yuan Yaozong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Jiaotong University, School of Medicine, Affiliated of Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}