Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-29 @ 4:55 AM
Study NCT ID:
NCT01005251
Status:
COMPLETED
Last Update Posted:
2011-04-25
First Post:
2009-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D006356', 'term': 'Heartburn'}], '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'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545087', 'term': 'lesogaberan'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "There is an agreement between PI and Sponsor (AZ) or its agents that restricts the PI's right to discuss/publish trial results after the trial is completed.The PI agrees to collaborate in good faith with AZ with regards to content and formation of any publication or disclosure to be made by PI and to pay due consideration to opinions offered by AZ.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'As a consequence of the definition of the analysis set for efficacy analysis and safety analysis respectively, one patient was included in the 120 mg group for efficacy analyses and in the 60 mg group for safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': 'AZD3355 60 mg', 'description': 'PPI+AZD3355 60 mg twice daily (bid)', 'otherNumAffected': 13, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'AZD3355 120 mg', 'description': 'PPI+AZD3355 120 mg twice daily (bid)', 'otherNumAffected': 12, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'AZD3355 180 mg', 'description': 'PPI+AZD3355 180 mg twice daily (bid)', 'otherNumAffected': 16, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'AZD3355 240 mg', 'description': 'PPI+AZD3355 240 mg twice daily (bid)', 'otherNumAffected': 20, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Placebo', 'description': 'PPI+Placebo', 'otherNumAffected': 9, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 10}, {'groupId': 'EG004', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 140, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Non-Cardiac Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 140, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Metastatic Gastric Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 135, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 124, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 136, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 126, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 140, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '126', 'groupId': 'OG003'}, {'value': '140', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD3355 60 mg', 'description': 'PPI+AZD3355 60 mg twice daily (bid)'}, {'id': 'OG001', 'title': 'AZD3355 120 mg', 'description': 'PPI+AZD3355 120 mg twice daily (bid)'}, {'id': 'OG002', 'title': 'AZD3355 180 mg', 'description': 'PPI+AZD3355 180 mg twice daily (bid)'}, {'id': 'OG003', 'title': 'AZD3355 240 mg', 'description': 'PPI+AZD3355 240 mg twice daily (bid)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'PPI+Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'The 7 days before randomisation (baseline) and during 26-30 days of treatment', 'description': 'Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary.\n\n(GERD = Gastroesophageal Reflux Disease)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}, {'value': '133', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}, {'value': '135', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'AZD3355 60 mg', 'description': 'PPI+AZD3355 60 mg twice daily (bid)'}, {'id': 'OG001', 'title': 'AZD3355 120 mg', 'description': 'PPI+AZD3355 120 mg twice daily (bid)'}, {'id': 'OG002', 'title': 'AZD3355 180 mg', 'description': 'PPI+AZD3355 180 mg twice daily (bid)'}, {'id': 'OG003', 'title': 'AZD3355 240 mg', 'description': 'PPI+AZD3355 240 mg twice daily (bid)'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'PPI+Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '35.7'}, {'value': '17.2', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '46.4'}, {'value': '11.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '40.9'}, {'value': '12.5', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '47.1'}, {'value': '0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '30.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The 7 days before randomisation (baseline) and during 26-30 days of treatment', 'description': 'Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary\n\n(GERD = Gastroesophageal Reflux Disease)', 'unitOfMeasure': 'Percent', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZD3355 60 mg', 'description': 'PPI+AZD3355 60 mg twice daily (bid)'}, {'id': 'FG001', 'title': 'AZD3355 120 mg', 'description': 'PPI+AZD3355 120 mg twice daily (bid)'}, {'id': 'FG002', 'title': 'AZD3355 180 mg', 'description': 'PPI+AZD3355 180 mg twice daily (bid)'}, {'id': 'FG003', 'title': 'AZD3355 240 mg', 'description': 'PPI+AZD3355 240 mg twice daily (bid)'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'PPI+Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '134'}, {'groupId': 'FG001', 'numSubjects': '125'}, {'groupId': 'FG002', 'numSubjects': '136'}, {'groupId': 'FG003', 'numSubjects': '126'}, {'groupId': 'FG004', 'numSubjects': '140'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '109'}, {'groupId': 'FG002', 'numSubjects': '114'}, {'groupId': 'FG003', 'numSubjects': '114'}, {'groupId': 'FG004', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '9'}]}, {'type': 'Eligibility criteria not fulfilled', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Developed study-specific withdrawal crit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Patient moved', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Wrong drug dispensed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Randomized in error', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}, {'value': '126', 'groupId': 'BG003'}, {'value': '140', 'groupId': 'BG004'}, {'value': '661', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'AZD3355 60 mg', 'description': 'PPI+AZD3355 60 mg twice daily (bid)'}, {'id': 'BG001', 'title': 'AZD3355 120 mg', 'description': 'PPI+AZD3355 120 mg twice daily (bid)'}, {'id': 'BG002', 'title': 'AZD3355 180 mg', 'description': 'PPI+AZD3355 180 mg twice daily (bid)'}, {'id': 'BG003', 'title': 'AZD3355 240 mg', 'description': 'PPI+AZD3355 240 mg twice daily (bid)'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'PPI+Placebo'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.4', 'spread': '12.3', 'groupId': 'BG000'}, {'value': '46.1', 'spread': '13.5', 'groupId': 'BG001'}, {'value': '48.0', 'spread': '12.3', 'groupId': 'BG002'}, {'value': '48.5', 'spread': '12.1', 'groupId': 'BG003'}, {'value': '48.3', 'spread': '12.0', 'groupId': 'BG004'}, {'value': '47.7', 'spread': '12.4', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '75', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '67', 'groupId': 'BG004'}, {'value': '376', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}, {'value': '285', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 661}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-29', 'studyFirstSubmitDate': '2009-10-27', 'resultsFirstSubmitDate': '2011-02-23', 'studyFirstSubmitQcDate': '2009-10-29', 'lastUpdatePostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-29', 'studyFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Change in GERD Symptoms Corresponding to at Least Three More Days of Not More Than Mild Symptoms on Average Per Week During Treatment (Approximately 4 Weeks) Than During Baseline (the 7 Days Before Randomisation)', 'timeFrame': 'The 7 days before randomisation (baseline) and during 26-30 days of treatment', 'description': 'Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary.\n\n(GERD = Gastroesophageal Reflux Disease)'}], 'secondaryOutcomes': [{'measure': 'Absolute Change From Baseline to Treatment Period in Percent Days With at Most Mild GERD Symptoms.', 'timeFrame': 'The 7 days before randomisation (baseline) and during 26-30 days of treatment', 'description': 'Symptom intensity rated by participants twice daily on a six-graded Likert scale (Did not have; Very mild; Mild; Moderate; Moderately severe; Severe) using an electronic Reflux Symptom Questionnaire diary\n\n(GERD = Gastroesophageal Reflux Disease)'}]}, 'conditionsModule': {'keywords': ['GERD treatment', 'Acid and non-acid Reflux', 'Heartburn', 'Regurgitation', 'Add-on treatment to PPI'], 'conditions': ['Gastroesophageal Reflux Disease', 'Heartburn', 'Regurgitation']}, 'referencesModule': {'references': [{'pmid': '23318482', 'type': 'DERIVED', 'citation': 'Shaheen NJ, Denison H, Bjorck K, Silberg DG. Esophageal mucosal breaks in gastroesophageal reflux disease partially responsive to proton pump inhibitor therapy. Am J Gastroenterol. 2013 Apr;108(4):529-34. doi: 10.1038/ajg.2012.447. Epub 2013 Jan 15.'}, {'pmid': '22730470', 'type': 'DERIVED', 'citation': 'Shaheen NJ, Denison H, Bjorck K, Karlsson M, Silberg DG. Efficacy and safety of lesogaberan in gastro-oesophageal reflux disease: a randomised controlled trial. Gut. 2013 Sep;62(9):1248-55. doi: 10.1136/gutjnl-2012-302737. Epub 2012 Jun 23.'}]}, 'descriptionModule': {'briefSummary': 'This study is being carried out to see whether AZD3355 is an effective treatment as an add-on to PPI therapy in patients with Gastroesophageal Reflux Disease (GERD) with a partial response to PPI and to compare this with Proton Pump Inhibitor (PPI) treatment alone. Another goal of the study is to examine which of the investigated doses of AZD3355 is optimal for treatment of these patients. This study will also measure levels of drug in the blood and see how well it is tolerated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures\n* Have at least 6 months history of GERD\n* Continuously treated during the last 4 weeks before enrolment with daily optimized unchanged PPI therapy for any GERD indication\n\nExclusion Criteria:\n\n* Patients that have not experienced any GERD symptom improvement at all during PPI treatment\n* Prior surgery of the upper gastrointestinal tract.\n* Subject 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'}, 'identificationModule': {'nctId': 'NCT01005251', 'briefTitle': 'Investigate the Effect of Different Doses of Lesogaberan (AZD3355) as add-on to PPI in GERD Patients With Partial Response to PPI', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'orgStudyIdInfo': {'id': 'D9120C00019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '60 mg', 'description': 'PPI+lesogaberan (AZD3355) 60 mg bid', 'interventionNames': ['Drug: lesogaberan (AZD3355)']}, {'type': 'EXPERIMENTAL', 'label': '120 mg', 'description': 'PPI+lesogaberan (AZD3355) 120 mg bid', 'interventionNames': ['Drug: lesogaberan (AZD3355)']}, {'type': 'EXPERIMENTAL', 'label': '180 mg', 'description': 'PPI+lesogaberan (AZD3355) 180 mg bid', 'interventionNames': ['Drug: lesogaberan (AZD3355)']}, {'type': 'EXPERIMENTAL', 'label': '240 mg', 'description': 'PPI+lesogaberan (AZD3355) 240 mg bid', 'interventionNames': ['Drug: lesogaberan (AZD3355)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'PPI+ Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'lesogaberan (AZD3355)', 'type': 'DRUG', 'description': '60 mg, oral, capsules, bid for 4 w', 'armGroupLabels': ['60 mg']}, {'name': 'lesogaberan (AZD3355)', 'type': 'DRUG', 'description': '120 mg, oral, capsules, bid for 4 w', 'armGroupLabels': ['120 mg']}, {'name': 'lesogaberan (AZD3355)', 'type': 'DRUG', 'description': '180 mg, oral, capsules, bid for 4 w', 'armGroupLabels': ['180 mg']}, {'name': 'lesogaberan (AZD3355)', 'type': 'DRUG', 'description': '240 mg, oral, capsules, bid for 4 w', 'armGroupLabels': ['240 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'oral,capsules, bid for 4 w', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Debra Silberg, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Nicholas Shaheen, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UNC Hospitals, 4141Chapel Hill, NC 27599 USA'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'MSD', 'oldOrganization': 'AstraZeneca'}}}}