Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2026-01-01 @ 10:00 PM
Study NCT ID:
NCT00679432
Status:
COMPLETED
Last Update Posted:
2019-12-10
First Post:
2008-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D019804', 'term': 'Mesalamine'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D062368', 'term': 'meta-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000636', 'term': 'Aminosalicylic Acids'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D010636', 'term': 'Phenols'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mhuang@santarus.com', 'phone': '8583145700', 'title': 'Michael Huang, MD, Senior Medical Director, Clinical Research', 'organization': 'Santarus, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '56 day ± 2 day (study duration) + 30 day safety followup period.', 'description': 'Adverse event data were analyzed using the safety population, defined as all patients who received study drug. 509 patients received study drug and were included in safety analyses.', 'eventGroups': [{'id': 'EG000', 'title': '1: Budesonide-MMX® 6 mg', 'description': 'One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nbudesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores', 'otherNumAtRisk': 126, 'otherNumAffected': 35, 'seriousNumAtRisk': 126, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '2: Budesonide-MMX® 9 mg', 'description': 'One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores\n\nbudesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets', 'otherNumAtRisk': 127, 'otherNumAffected': 36, 'seriousNumAtRisk': 127, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': '3: Placebo', 'description': 'Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nPlacebo : Placebo\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores', 'otherNumAtRisk': 129, 'otherNumAffected': 34, 'seriousNumAtRisk': 129, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': '4: Asacol® 400 mg', 'description': 'Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nAsacol® 400 mg : 2400 mg/day, 400 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores', 'otherNumAtRisk': 127, 'otherNumAffected': 31, 'seriousNumAtRisk': 127, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 20, 'numAffected': 20}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 9, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Blood cortisol decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Blood urine present', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 9, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 8, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 29, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 14, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 31, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 15, 'numAffected': 12}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Mood altered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}], 'seriousEvents': [{'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Large intestine perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Pelvic abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Renal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 126, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA V11.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical and Endoscopic Remission.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1: Budesonide-MMX® 6 mg', 'description': 'One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nbudesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}, {'id': 'OG001', 'title': '2: Budesonide-MMX® 9 mg', 'description': 'One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores\n\nbudesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nPlacebo : Placebo\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}, {'id': 'OG003', 'title': '4: Asacol® 400 mg', 'description': 'Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nAsacol® 400 mg : 2400 mg/day, 400 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}], 'classes': [{'categories': [{'measurements': [{'value': '13.2', 'groupId': 'OG000', 'lowerLimit': '7.2', 'upperLimit': '19.3'}, {'value': '17.9', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '24.7'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '2.8', 'upperLimit': '12.1'}, {'value': '12.1', 'groupId': 'OG003', 'lowerLimit': '6.4', 'upperLimit': '17.8'}]}]}], 'analyses': [{'pValue': '0.1393', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-1.8', 'ciUpperLimit': '13.4', 'estimateComment': 'The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).', 'groupDescription': 'All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Asacol and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Asacol versus budesonide MMX.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.0143', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.4', 'ciLowerLimit': '2.2', 'ciUpperLimit': '18.7', 'estimateComment': 'See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).', 'groupDescription': 'See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.2200', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.7', 'ciLowerLimit': '-2.7', 'ciUpperLimit': '12.1', 'estimateComment': 'See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).', 'groupDescription': 'See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Clinical and endoscopic remission defined as a Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3\\[infectious colitis\\] - 17\\[normal histology at baseline\\] = 489).'}, {'type': 'SECONDARY', 'title': 'Clinical Improvement.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1: Budesonide-MMX® 6 mg', 'description': 'One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nbudesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}, {'id': 'OG001', 'title': '2: Budesonide-MMX® 9 mg', 'description': 'One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores\n\nbudesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nPlacebo : Placebo\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}, {'id': 'OG003', 'title': '4: Asacol® 400 mg', 'description': 'Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nAsacol® 400 mg : 2400 mg/day, 400 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}], 'classes': [{'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000', 'lowerLimit': '22.4', 'upperLimit': '38.8'}, {'value': '33.3', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '41.7'}, {'value': '24.8', 'groupId': 'OG002', 'lowerLimit': '17.1', 'upperLimit': '32.5'}, {'value': '33.9', 'groupId': 'OG003', 'lowerLimit': '25.5', 'upperLimit': '42.2'}]}]}], 'analyses': [{'pValue': '0.3146', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-5.5', 'ciUpperLimit': '17.0', 'estimateComment': 'The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).', 'groupDescription': 'Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1420', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.5', 'ciLowerLimit': '-2.8', 'ciUpperLimit': '19.9', 'estimateComment': 'See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).', 'groupDescription': 'See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}, {'pValue': '0.1189', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.1', 'ciLowerLimit': '-2.3', 'ciUpperLimit': '20.4', 'estimateComment': 'See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).', 'groupDescription': 'See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3\\[infectious colitis\\] - 17\\[normal histology at baseline\\] = 489).'}, {'type': 'SECONDARY', 'title': 'Endoscopic Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '124', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1: Budesonide-MMX® 6 mg', 'description': 'One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nbudesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}, {'id': 'OG001', 'title': '2: Budesonide-MMX® 9 mg', 'description': 'One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores\n\nbudesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets'}, {'id': 'OG002', 'title': '3: Placebo', 'description': 'Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nPlacebo : Placebo\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}, {'id': 'OG003', 'title': '4: Asacol® 400 mg', 'description': 'Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nAsacol® 400 mg : 2400 mg/day, 400 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}], 'classes': [{'categories': [{'measurements': [{'value': '35.5', 'groupId': 'OG000', 'lowerLimit': '27', 'upperLimit': '44.1'}, {'value': '41.5', 'groupId': 'OG001', 'lowerLimit': '32.8', 'upperLimit': '50.2'}, {'value': '33.1', 'groupId': 'OG002', 'lowerLimit': '24.7', 'upperLimit': '41.4'}, {'value': '33.1', 'groupId': 'OG003', 'lowerLimit': '24.8', 'upperLimit': '41.3'}]}]}], 'analyses': [{'pValue': '0.9991', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Difference in proportions', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.0', 'ciLowerLimit': '-11.8', 'ciUpperLimit': '11.8', 'estimateComment': 'The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).', 'groupDescription': 'As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Asacol and placebo groups is shown here.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'description': 'Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.\n\nAs per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted.', 'unitOfMeasure': 'percentage of patients', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3\\[infectious colitis\\] - 17\\[normal histology at baseline\\] = 489).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1: Budesonide-MMX® 6 mg', 'description': 'One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nbudesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}, {'id': 'FG001', 'title': '2: Budesonide-MMX® 9 mg', 'description': 'One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores\n\nbudesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets'}, {'id': 'FG002', 'title': '3: Placebo', 'description': 'Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nPlacebo : Placebo\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}, {'id': 'FG003', 'title': '4: Asacol® 400 mg', 'description': 'Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nAsacol® 400 mg : 2400 mg/day, 400 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '129'}, {'groupId': 'FG003', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '89'}, {'groupId': 'FG001', 'numSubjects': '89'}, {'groupId': 'FG002', 'numSubjects': '76'}, {'groupId': 'FG003', 'numSubjects': '95'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '53'}, {'groupId': 'FG003', 'numSubjects': '32'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '7'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'Infectious colitis, normal histology', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'Randomization error, return to prior Rx', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruited from August 2008 until May 2010.', 'preAssignmentDetails': 'Diary data for symptoms will be collected prior to randomization. Lab testing and a colonoscopy will be done prior to randomization. 510 patients were randomized. One patient was not treated and was not included in baseline characteristics, efficacy, and safety analyses. 509 patients received study drug and were included in safety analyses.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '121', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}, {'value': '489', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '1: Budesonide-MMX® 6 mg', 'description': 'One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nbudesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}, {'id': 'BG001', 'title': '2: Budesonide-MMX® 9 mg', 'description': 'One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores\n\nbudesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets'}, {'id': 'BG002', 'title': '3: Placebo', 'description': 'Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nPlacebo : Placebo\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}, {'id': 'BG003', 'title': '4: Asacol® 400 mg', 'description': 'Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.\n\nAsacol® 400 mg : 2400 mg/day, 400 mg tablets\n\nBlood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '122', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}, {'value': '118', 'groupId': 'BG003'}, {'value': '472', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'spread': '13', 'groupId': 'BG000'}, {'value': '41.7', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '41.7', 'spread': '13.6', 'groupId': 'BG002'}, {'value': '44', 'spread': '12.4', 'groupId': 'BG003'}, {'value': '42.7', 'spread': '12.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '216', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}, {'value': '273', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}, {'value': '304', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}, {'value': '162', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3\\[infectious colitis\\] - 17\\[normal histology at baseline\\] = 489).'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 510}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'dispFirstSubmitDate': '2011-12-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-26', 'studyFirstSubmitDate': '2008-05-14', 'dispFirstSubmitQcDate': '2012-02-09', 'resultsFirstSubmitDate': '2014-04-25', 'studyFirstSubmitQcDate': '2008-05-15', 'dispFirstPostDateStruct': {'date': '2012-02-13', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-07-03', 'studyFirstPostDateStruct': {'date': '2008-05-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and Endoscopic Remission.', 'timeFrame': '8 weeks', 'description': 'Clinical and endoscopic remission defined as a Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.'}], 'secondaryOutcomes': [{'measure': 'Clinical Improvement.', 'timeFrame': '8 weeks', 'description': 'Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.'}, {'measure': 'Endoscopic Improvement', 'timeFrame': '8 weeks', 'description': 'Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.\n\nAs per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ulcerative colitis'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '22892337', 'type': 'RESULT', 'citation': 'Sandborn WJ, Travis S, Moro L, Jones R, Gautille T, Bagin R, Huang M, Yeung P, Ballard ED 2nd. Once-daily budesonide MMX(R) extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012 Nov;143(5):1218-1226.e2. doi: 10.1053/j.gastro.2012.08.003. Epub 2012 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.', 'detailedDescription': 'Each patient will receive one of the following regimens in the morning after breakfast:\n\n1. one budesonide-MMX™ 6 mg tablet plus two placebo Asacol® over encapsulated tablets, or\n2. one budesonide-MMX™ 9 mg tablet plus two placebo Asacol® over encapsulated tablets, or\n3. two placebo Asacol® over encapsulated tablets plus one placebo budesonide tablet, or\n4. two Asacol® 400 mg over encapsulated tablets plus one placebo budesonide tablet, daily for 8 weeks.\n\nEach patient will also receive on each day after the midday meal and after the evening meal either:\n\n* two Asacol® 400 mg over-encapsulated tablets (Group 4), or\n* the equivalent placebo Asacol® over-encapsulated tablets, (Groups 1, 2 and 3)\n\nHence, each patient is to take seven tablets per day of active or placebo study medication as per the randomization schedule. Placebo tablets of budesonide-MMX™ and placebo over-encapsulated tablets of Asacol® will be used to maintain the study blind using a double-dummy technique.\n\nDuring the study, five visits to the clinical center are scheduled: one at Screening and three in the double-blind treatment period (Day 1, Day 14, Day 28 and Day 56). A safety follow up visit will take place about 2 weeks after the final study visit. If a patient is withdrawn from the study before Day 56, they will be asked to attend the study center as soon as possible thereafter so that the Final visit assessments can be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients fulfilling the following criteria at the screening visit are eligible for participation in the study:\n\n * Male and female patients, 18-75 years old, suffering from ulcerative colitis for at least 6 months.\n * Diagnosis of ulcerative colitis in active phase, of mild or moderate entity with Ulcerative Colitis Disease Activity Index (UCDAI) ≥ 4 and ≤ 10 according to Sutherland.\n * All females of child-bearing potential must have a negative serum pregnancy test immediately prior to enrollment. In addition, all females of child-bearing potential must agree to be completely abstinent or be using an accepted form of contraception throughout the entire study period. Accepted forms of contraception are defined as those with a failure rate \\<1% when properly applied and include: combination oral pill, some intra-uterine devices, and a sterilised partner in a stable relationship. Female subjects must also not be actively breast-feeding through the entire study period.\n * Ability to comprehend the full nature and purpose of the study, including possible risks and side effects.\n * Ability to co-operate with the investigator and to comply with the requirements of the entire study.\n * Must be able to understand and voluntarily sign written informed consent prior to inclusion in the study.\n\nExclusion Criteria:\n\n* Patients who meet any of the following criteria at screening visit are to be excluded from study participation:\n\n * Patients with limited distal proctitis (from anal verge up to 15 cm above the pectineal line).\n * Patients with severe ulcerative colitis (UCDAI \\>10).\n * Patients with infectious colitis.\n * Evidence or history of toxic megacolon.\n * Severe anemia, leucopenia or granulocytopenia.\n * Use of oral or rectal steroids in the last 4 weeks.\n * Use of immuno-suppressive agents in the last 8 weeks before the study.\n * Use of anti tumor necrosis factor alpha (anti-TNFα) agents in the last 3 months.\n * Concomitant use of any rectal preparation.\n * Concomitant use of antibiotics.\n * Concurrent use of cytochrome P450 3A4 (CYP3A4) inducers or CYP3A4 inhibitors.\n * Patients with intolerance to salicylates.\n * Patients with verified, presumed or expected pregnancy or ongoing lactation.\n * Patients with liver cirrhosis, or evident hepatic or renal disease or insufficiency, and/or severe impairment of the bio-humoral parameters (i.e. 2 x upper limit of normal for alanine aminotransferase \\[ALT\\], aspartate aminotransferase \\[AST\\], gamma glutamyl transpeptidase \\[GGT\\] or creatinine).\n * Patient with severe diseases in other organs and systems.\n * Patients with local or systemic complications or other pathological states requiring a therapy with corticosteroids and/or immuno-suppressive agents.\n * Patients diagnosed with type 1 diabetes.\n * Patients diagnosed with, or with a family history of, glaucoma.\n * All patients with known hepatitis B, hepatitis C or with human immunodeficiency virus (HIV), according to the local privacy policy.\n * Participation in experimental therapeutic studies in the last 3 months. (Note: patients who participated in observational only studies are not excluded).\n * Any other medical condition that in the principal investigator's opinion would make the administration of the study drug or study procedures hazardous to the subject or obscure the interpretation of adverse events (AEs)."}, 'identificationModule': {'nctId': 'NCT00679432', 'briefTitle': '(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'Efficacy and Safety of New Oral Budesonide-MMX™ (CB-01-02) 6 mg and 9 mg Extended Release Tablet Formulations in Patients With Mild or Moderate, Active Ulcerative Colitis. A Multicenter, Randomized, Double-blind, Double Dummy Comparative Study Versus Placebo, With an Additional Reference Arm Evaluating Asacol® 2400 mg.', 'orgStudyIdInfo': {'id': 'CB-01-02/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1: budesonide-MMX® 6 mg', 'description': 'One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.', 'interventionNames': ['Procedure: Blood sampling, endoscopy', 'Drug: budesonide-MMX® 6 mg']}, {'type': 'EXPERIMENTAL', 'label': '2: budesonide-MMX® 9 mg', 'description': 'One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.', 'interventionNames': ['Procedure: Blood sampling, endoscopy', 'Drug: budesonide-MMX® 9 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3: Placebo', 'description': 'Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.', 'interventionNames': ['Procedure: Blood sampling, endoscopy', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4: Asacol® 400 mg', 'description': 'Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks.', 'interventionNames': ['Procedure: Blood sampling, endoscopy', 'Drug: Asacol® 400 mg']}], 'interventions': [{'name': 'Blood sampling, endoscopy', 'type': 'PROCEDURE', 'description': 'Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores', 'armGroupLabels': ['1: budesonide-MMX® 6 mg', '2: budesonide-MMX® 9 mg', '3: Placebo', '4: Asacol® 400 mg']}, {'name': 'budesonide-MMX® 6 mg', 'type': 'DRUG', 'description': '6 mg/day, 6 mg tablets', 'armGroupLabels': ['1: budesonide-MMX® 6 mg']}, {'name': 'budesonide-MMX® 9 mg', 'type': 'DRUG', 'description': '9 mg/day, 9 mg tablets', 'armGroupLabels': ['2: budesonide-MMX® 9 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['3: Placebo']}, {'name': 'Asacol® 400 mg', 'type': 'DRUG', 'description': '2400 mg/day, 400 mg tablets', 'armGroupLabels': ['4: Asacol® 400 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5051', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36606', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5102', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '35150', 'city': 'Sylacauga', 'state': 'Alabama', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5014', 'geoPoint': {'lat': 33.17317, 'lon': -86.25164}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5088', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5044', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5099', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '94536', 'city': 'Fremont', 'state': 'California', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5075', 'geoPoint': {'lat': 37.54827, 'lon': -121.98857}}, {'zip': '90712', 'city': 'Lakewood', 'state': 'California', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5087', 'geoPoint': {'lat': 33.85363, 'lon': -118.13396}}, {'zip': '90045', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5033', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92262', 'city': 'Palm Springs', 'state': 'California', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5070', 'geoPoint': {'lat': 33.8303, 'lon': -116.54529}}, {'zip': '92101', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5067', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94117', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5028', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '33426', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5089', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5041', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '32168', 'city': 'New Smyrna Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5055', 'geoPoint': {'lat': 29.02582, 'lon': -80.927}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5074', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5032', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5009', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33409', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5110', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5047', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '33542', 'city': 'Zephyrhills', 'state': 'Florida', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5003', 'geoPoint': {'lat': 28.23362, 'lon': -82.18119}}, {'zip': '30312', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5016', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31904', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5056', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5103', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60101', 'city': 'Addison', 'state': 'Illinois', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5085', 'geoPoint': {'lat': 41.9317, 'lon': -87.98896}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5068', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '47403', 'city': 'Bloomington', 'state': 'Indiana', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5086', 'geoPoint': {'lat': 39.16533, 'lon': -86.52639}}, {'zip': '50325', 'city': 'Clive', 'state': 'Iowa', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5053', 'geoPoint': {'lat': 41.60304, 'lon': -93.72411}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5008', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5090', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}, {'zip': '21229', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5025', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20636', 'city': 'Hollywood', 'state': 'Maryland', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5092', 'geoPoint': {'lat': 39.07511, 'lon': -76.5858}}, {'zip': '20678', 'city': 'Prince Frederick', 'state': 'Maryland', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5077', 'geoPoint': {'lat': 38.5404, 'lon': -76.5844}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5046', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02301', 'city': 'Brockton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5115', 'geoPoint': {'lat': 42.08343, 'lon': -71.01838}}, {'zip': '48047', 'city': 'Chesterfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5010', 'geoPoint': {'lat': 42.66281, 'lon': -82.84242}}, {'zip': '48098', 'city': 'Troy', 'state': 'Michigan', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5006', 'geoPoint': {'lat': 42.60559, 'lon': -83.14993}}, {'zip': '49519', 'city': 'Wyoming', 'state': 'Michigan', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5004', 'geoPoint': {'lat': 42.91336, 'lon': -85.70531}}, {'zip': '63128', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5105', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08234', 'city': 'Egg Harbor', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5094', 'geoPoint': {'lat': 39.38646, 'lon': -74.60361}}, {'zip': '08053', 'city': 'Marlton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5005', 'geoPoint': {'lat': 39.89122, 'lon': -74.92183}}, {'zip': '08360', 'city': 'Vineland', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Santarus Clinical Investigational Site 5024', 'geoPoint': {'lat': 39.48623, 'lon': -75.02573}}, {'zip': '11021', 'city': 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