Ignite Creation Date:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-28 @ 12:02 AM
Study NCT ID:
NCT00703534
Status:
COMPLETED
Last Update Posted:
2011-06-20
First Post:
2008-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms
Sponsor:
Organization:
Raw JSON
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If study site/investigator requests permission to publish data(incl oral presentations) it is to be agreed with AZ prior to publ.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AZD3355', 'description': 'AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed', 'otherNumAffected': 18, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo capsules twice daily, Gelusil tablets as rescue medication if needed', 'otherNumAffected': 7, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': 'Operative Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Suicide Attemp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 235, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 243, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD3355', 'description': 'AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo capsules twice daily, Gelusil tablets as rescue medication if needed'}], 'paramType': 'NUMBER', 'timeFrame': 'Run-in period of 8-12 days and treatment period of 26-30 days', 'description': 'Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'None of the analyses addressing the objectives related to validation of the patient reported outcome measures were made per treatment arm and can therefore not be reported in this format.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD3355', 'description': 'AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo capsules twice daily, Gelusil tablets as rescue medication if needed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '235'}, {'groupId': 'FG001', 'numSubjects': '243'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '205'}, {'groupId': 'FG001', 'numSubjects': '218'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '25'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Incorrect Enrollment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Severe Non Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '235', 'groupId': 'BG000'}, {'value': '243', 'groupId': 'BG001'}, {'value': '478', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD3355', 'description': 'AZD3355 capsules 65 mg twice daily, Gelusil tablets as rescue medication if needed'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo capsules twice daily, Gelusil tablets as rescue medication if needed'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.7', 'spread': '10.09', 'groupId': 'BG000'}, {'value': '47.8', 'spread': '11.5', 'groupId': 'BG001'}, {'value': '48.7', 'spread': '11.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '280', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '90', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 478}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-20', 'studyFirstSubmitDate': '2008-06-19', 'resultsFirstSubmitDate': '2011-02-04', 'studyFirstSubmitQcDate': '2008-06-19', 'lastUpdatePostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-05-20', 'studyFirstPostDateStruct': {'date': '2008-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Intensity Rated by Participants Twice Daily Using an Electronic Reflux Symptom Questionnaire Diary', 'timeFrame': 'Run-in period of 8-12 days and treatment period of 26-30 days', 'description': 'Symptom intensity rated on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GERD', 'Acid Reflux', 'Heartburn', 'Regurgitation', 'non-acid reflux', 'PRO measures'], 'conditions': ['GERD', 'Acid Reflux Disease', 'Heartburn', 'Regurgitation']}, 'referencesModule': {'references': [{'pmid': '27712711', 'type': 'DERIVED', 'citation': 'Ryden A, Leavy OC, Halling K, Stone AA. Comparison of Daily versus Weekly Recording of Gastroesophageal Reflux Disease Symptoms in Patients with a Partial Response to Proton Pump Inhibitor Therapy. Value Health. 2016 Sep-Oct;19(6):829-833. doi: 10.1016/j.jval.2016.05.007. Epub 2016 Jun 29.'}, {'pmid': '25304129', 'type': 'DERIVED', 'citation': 'Vakil N, Niklasson A, Denison H, Ryden A. Symptom profile in partial responders to a proton pump inhibitor compared with treatment-naive patients with gastroesophageal reflux disease: a post hoc analysis of two study populations. BMC Gastroenterol. 2014 Oct 10;14:177. doi: 10.1186/1471-230X-14-177.'}, {'pmid': '23919738', 'type': 'DERIVED', 'citation': 'Ryden A, Denison H, Karlsson M, Vakil N. Development and validation of a patient-reported outcome instrument in partial responders to proton pump inhibitors. Scand J Gastroenterol. 2013 Sep;48(9):1018-26. doi: 10.3109/00365521.2013.822544. Epub 2013 Aug 6.'}]}, 'descriptionModule': {'briefSummary': 'This research study is being done to gather information about how to do further clinical studies using AZD3355 as an add-on treatment to proton pump inhibitors (PPI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject able to read and write US english and able to use electronic devices\n* Subjects who have experienced GERD symptoms for at least six months\n* Subjects currently taking a prescription or over-the-counter PPI medications for GERD\n* Body Mass Index (BMI) 18.5-35.0, inclusive\n\nExclusion Criteria:\n\n* Subjects that have not experienced any GERD symptoms improvement at all after PPI treatment\n* Subjects who have any of the following conditions or diseases- Heart disease, Angina, Seizure disorders such as epilepsy, Congestive Heart Failure (CHF), Liver disease such as Cirrhosis or Hepatitis, Kidney disease, Lung disease or lung cancer, Cancer\n* Prior surgery of the upper Gastrointestinal (GI) tract'}, 'identificationModule': {'nctId': 'NCT00703534', 'acronym': 'C27', 'briefTitle': 'Validation of Patient-reported Outcomes Measures for the Assessment of Gastroesophageal Reflux Disease (GERD) Symptoms', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Validation of Patient-reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to Proton Pump Inhibitor (PPI) Treatment in a Two Part Multi-center Phase IIa Study Including a Four Week Randomised, Double-blind, Placebo-controlled, Parallel-group Treatment Period', 'orgStudyIdInfo': {'id': 'D9120C00027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZD3355', 'interventionNames': ['Drug: AZD3355', 'Drug: Gelusil®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 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