Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-31 @ 2:43 AM
Study NCT ID:
NCT00573469
Status:
COMPLETED
Last Update Posted:
2012-07-12
First Post:
2007-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Gerard Lynch', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'All PIs were prohibited to disclose all information related to this study without AZ approval before this study was completed.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'D9421-C 9 mg', 'description': 'An enteric capsule including D9421-C 9 mg was given once daily.', 'otherNumAtRisk': 26, 'otherNumAffected': 18, 'seriousNumAtRisk': 26, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'D9421-C 15 mg', 'description': 'An enteric capsule including D9421-C 15 mg was given once daily.', 'otherNumAtRisk': 25, 'otherNumAffected': 8, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Placebo', 'description': 'An enteric capsule without D9421-C was given once daily.', 'otherNumAtRisk': 26, 'otherNumAffected': 6, 'seriousNumAtRisk': 26, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': "Crohn's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'seriousEvents': [{'term': "Crohn's Disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Perianal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'D9421-C 9 mg', 'description': 'An enteric capsule including D9421-C 9 mg was given once daily.'}, {'id': 'OG001', 'title': 'D9421-C 15 mg', 'description': 'An enteric capsule including D9421-C 15 mg was given once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'An enteric capsule without D9421-C was given once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 8 weeks', 'description': "Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'D9421-C 9 mg', 'description': 'An enteric capsule including D9421-C 9 mg was given once daily.'}, {'id': 'OG001', 'title': 'D9421-C 15 mg', 'description': 'An enteric capsule including D9421-C 15 mg was given once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'An enteric capsule without D9421-C was given once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 2 weeks', 'description': "The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': "Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment", 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'D9421-C 9 mg', 'description': 'An enteric capsule including D9421-C 9 mg was given once daily.'}, {'id': 'OG001', 'title': 'D9421-C 15 mg', 'description': 'An enteric capsule including D9421-C 15 mg was given once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'An enteric capsule without D9421-C was given once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to 4 weeks', 'description': "The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'D9421-C 9 mg', 'description': 'An enteric capsule including D9421-C 9 mg was given once daily.'}, {'id': 'OG001', 'title': 'D9421-C 15 mg', 'description': 'An enteric capsule including D9421-C 15 mg was given once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'An enteric capsule without D9421-C was given once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.5', 'spread': '77.7', 'groupId': 'OG000'}, {'value': '36.0', 'spread': '84.7', 'groupId': 'OG001'}, {'value': '19.0', 'spread': '89.9', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 8 weeks', 'description': "Time from randomisation to the remission of Crohn's disease defined as CDAI score \uf0a3 150 was analysed by Kaplan-Miere method. From this method, the cumulative percentage of participants who obtained up to 8 weeks were obtained.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in CDAI Score From Baseline to 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'D9421-C 9 mg', 'description': 'An enteric capsule including D9421-C 9 mg was given once daily.'}, {'id': 'OG001', 'title': 'D9421-C 15 mg', 'description': 'An enteric capsule including D9421-C 15 mg was given once daily.'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'An enteric capsule without D9421-C was given once daily.'}], 'classes': [{'categories': [{'measurements': [{'value': '-48', 'spread': '77.5', 'groupId': 'OG000'}, {'value': '-58', 'spread': '84.7', 'groupId': 'OG001'}, {'value': '-27', 'spread': '89.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': "CDAI score is an index showing the condition of Crohn's disease and has no unit. The minimum is 0 and the maximum is not defined. Higher score shows worse condition and a decrease in score means improvement. In this study, participants who had 200 or higher of CDAI score were enrolled. The change from baseline to 8 weeks in CDAI score was measured.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'D9421-C 9 mg', 'description': 'An enteric capsule including D9421-C 9 mg was given once daily.'}, {'id': 'FG001', 'title': 'D9421-C 15 mg', 'description': 'An enteric capsule including D9421-C 15 mg was given once daily.'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'An enteric capsule without D9421-C was given once daily.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'First participant enrolled on 16 October 2006. Last participant completed on 4 March 2008.\n\nOut of 90 screened participants, 77 participants (target was 75) were enrolled and included in Full Analysis set and safety analysis set. The numbers of participants in each set were 26 in D9421-C 9 mg, 25 in D9421-C 15 mg and 26 in Placebo, respectively.', 'preAssignmentDetails': 'Patients who had a CDAI score of less than 200 were excluded before randomisation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '77', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'D9421-C 9 mg', 'description': 'An enteric capsule including D9421-C 9 mg was given once daily.'}, {'id': 'BG001', 'title': 'D9421-C 15 mg', 'description': 'An enteric capsule including D9421-C 15 mg was given once daily.'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'An enteric capsule without D9421-C was given once daily.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<30 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '19.0', 'groupId': 'BG003'}]}]}, {'title': '>=30 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '58.0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'description': 'Age in Years', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '22.0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '55.0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Gender', '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': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-02', 'studyFirstSubmitDate': '2007-12-13', 'resultsFirstSubmitDate': '2009-03-18', 'studyFirstSubmitQcDate': '2007-12-13', 'lastUpdatePostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-01-19', 'studyFirstPostDateStruct': {'date': '2007-12-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Number of Participants Who Had Remission of Crohn's Disease After 8-week Treatment", 'timeFrame': 'Baseline to 8 weeks', 'description': "Remission is defined by a Crohn's Disease Activity Index (CDAI) score of ≤ 150. That is, if a participant had 150 or less of CDAI score after 8-week treatment, the participant had the remission of Crohn's disease. The number of participants who had remission of Crohn's disease after 8-week treatment was the primary measure of this study."}], 'secondaryOutcomes': [{'measure': "Number of Participants Who Had Remission of Crohn's Disease After 2-week Treatment", 'timeFrame': 'Baseline to 2 weeks', 'description': "The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study."}, {'measure': "Number of Participants Who Had Remission of Crohn's Disease After 4-week Treatment", 'timeFrame': 'Baseline to 4 weeks', 'description': "The number of participants who had remission of Crohn's disease (i.e., CDAI score ≤ 150) after 2-week treatment was one of the secondary measures of this study."}, {'measure': 'Cumulative Percentage of Participants Who Achieved Remission up to 8 Weeks by Kaplan-Meier Method', 'timeFrame': 'At 8 weeks', 'description': "Time from randomisation to the remission of Crohn's disease defined as CDAI score \uf0a3 150 was analysed by Kaplan-Miere method. From this method, the cumulative percentage of participants who obtained up to 8 weeks were obtained."}, {'measure': 'Change in CDAI Score From Baseline to 8 Weeks', 'timeFrame': 'Baseline to 8 weeks', 'description': "CDAI score is an index showing the condition of Crohn's disease and has no unit. The minimum is 0 and the maximum is not defined. Higher score shows worse condition and a decrease in score means improvement. In this study, participants who had 200 or higher of CDAI score were enrolled. The change from baseline to 8 weeks in CDAI score was measured."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gastrointestinal', 'GI', "Crohn's disease", 'Japan', 'Japanese'], 'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '22766525', 'type': 'DERIVED', 'citation': "Suzuki Y, Motoya S, Takazoe M, Kosaka T, Date M, Nii M, Hibi T. Efficacy and tolerability of oral budesonide in Japanese patients with active Crohn's disease: a multicentre, double-blind, randomized, parallel-group Phase II study. J Crohns Colitis. 2013 Apr;7(3):239-47. doi: 10.1016/j.crohns.2012.06.006. Epub 2012 Jul 4."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether treatment with D9421-C for 8 weeks in Japanese patients with mild to moderate active Crohn's disease will improve their symptoms of Crohn's disease and quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female or male aged ≥ 18 and ≤ 65 years\n* Diagnosis of Crohn's Disease\n\nExclusion Criteria:\n\n* Having ileostomy or pouch and/or colostomy\n* Having previous gastric surgery\n* Having a known or suspected systemic infection"}, 'identificationModule': {'nctId': 'NCT00573469', 'briefTitle': "Efficacy and Safety Study of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': "A Multicentre, Double-blind, Randomised, Parallel-group, Phase II Study to Assess Efficacy and Safety of D9421-C 9 mg and 15 mg Versus Placebo in Japanese Patients With Active Crohn's Disease", 'orgStudyIdInfo': {'id': 'D9421C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'D9421-C 9 mg', 'interventionNames': ['Drug: D9421-C, 9mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'D9421-C 15 mg', 'interventionNames': ['Drug: D9421-C, 15mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'D9421-C, 9mg', 'type': 'DRUG', 'description': 'D9421-C 9 mg was given once daily for 8 weeks.', 'armGroupLabels': ['1']}, {'name': 'D9421-C, 15mg', 'type': 'DRUG', 'description': 'D9421-C 15 mg was given once daily for 8 weeks.', 'armGroupLabels': ['2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'D9421-C matching placebo was given once daily for 8 weeks.', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'city': 'Sakura', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.71667, 'lon': 140.23333}}, {'city': 'Chikushino-shi', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.49631, 'lon': 130.5156}}, {'city': 'Fukuoka', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.6, 'lon': 130.41667}}, {'city': 'Kurume', 'state': 'Fukuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.31667, 'lon': 130.51667}}, {'city': 'Hashima-gun', 'state': 'Gifu', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Fukuyama', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'city': 'Hiroshima', 'state': 'Hiroshima', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.4, 'lon': 132.45}}, {'city': 'Asahikawa', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.77063, 'lon': 142.36489}}, {'city': 'Sapporo', 'state': 'Hokkaido', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 43.06667, 'lon': 141.35}}, {'city': 'Kobe', 'state': 'Hyōgo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.6913, 'lon': 135.183}}, {'city': 'Kyoto', 'state': 'Kyoto', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.02107, 'lon': 135.75385}}, {'city': 'Ōita', 'state': 'Oita Prefecture', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}, {'city': 'Kurashiki', 'state': 'Okayama-ken', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.58333, 'lon': 133.76667}}, {'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'city': 'Tokorozawa', 'state': 'Saitama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.79916, 'lon': 139.46903}}, {'city': 'Shinjuku-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site'}, {'city': 'Toyama', 'state': 'Toyama', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.7, 'lon': 137.21667}}, {'city': 'Itami', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.78427, 'lon': 135.40126}}, {'city': 'Nishinomiya', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.71562, 'lon': 135.33199}}, {'city': 'Tokyo', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Masataka Date, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}