Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-06 @ 11:33 PM
Study NCT ID:
NCT00151892
Status:
COMPLETED
Last Update Posted:
2021-06-14
First Post:
2005-09-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of SPD476 in Maintaining Remission 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': 'D019804', 'term': 'Mesalamine'}], 'ancestors': [{'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': 'ClinicalTransparency@shire.com', 'phone': '+1 866 842 5335', 'title': 'Study Director', 'organization': 'Shire'}, 'certainAgreement': {'otherDetails': 'If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Safety population defined as all randomized subjects who received at least 1 dose of investigational medication.', 'eventGroups': [{'id': 'EG000', 'title': 'SPD476', 'description': '2.4 g/day QD', 'otherNumAtRisk': 415, 'otherNumAffected': 0, 'seriousNumAtRisk': 415, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Asacol', 'description': '1.6g/day administered 800 mg BID', 'otherNumAtRisk': 411, 'otherNumAffected': 0, 'seriousNumAtRisk': 411, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 411, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 411, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 411, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 411, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Fallopian tube perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 411, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Post procedural hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 411, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 411, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Radiculitis brachial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 411, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Ectopic pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 415, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 411, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 415, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 411, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476', 'description': '2.4 g/day QD'}, {'id': 'OG001', 'title': 'Asacol', 'description': '1.6g/day administered 800 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '83.7', 'groupId': 'OG000'}, {'value': '81.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in proportions', 'ciPctValue': '95', 'paramValue': '0.02', 'ciLowerLimit': '-0.04', 'ciUpperLimit': '0.08', 'groupDescription': 'The null hypothesis to be tested is that the true difference in proportions is less than or equal to -10%.', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE_LEGACY', 'nonInferiorityComment': 'A 2-sided 95% confidence interval (CI) for the difference in the percentages of subjects in remission at 6 months of the two treatment groups will be computed. Non-inferiority of SPD476 to Asacol will be concluded if the lower limit of the 95% CI lies above the non-inferiority margin of -10%.'}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal \\[intact vascular pattern; no friability or granulation\\], 1 = mild \\[erythema; decreased vascular pattern; minimal granularity\\], 2 = moderate \\[marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations\\], 3 = severe \\[ulceration; spontaneous bleeding\\].', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population (PP) defined as all subjects who either completed the study or withdrew for reasons related to efficacy or AEs and who were deemed to be protocol-compliant.'}, {'type': 'SECONDARY', 'title': 'Withdrawal Due to Relapse of UC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476', 'description': '2.4 g/day QD'}, {'id': 'OG001', 'title': 'Asacol', 'description': '1.6g/day administered 800 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Over 6 Months', 'description': 'Relapse is defined as withdrawal from the study due to lack of efficacy.', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Endoscopic Remission of UC With No or Mild Symptoms at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}, {'value': '336', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476', 'description': '2.4 g/day QD'}, {'id': 'OG001', 'title': 'Asacol', 'description': '1.6g/day administered 800 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '79.0', 'groupId': 'OG000'}, {'value': '75.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 Months', 'description': 'Endoscopic remission with no or mild symptoms is defined as an endoscopy score of less than or equal to 1 and a combined symptom score (stool frequency plus rectal bleeding) of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).', 'unitOfMeasure': 'percent of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '290', 'groupId': 'OG000'}, {'value': '281', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476', 'description': '2.4 g/day QD'}, {'id': 'OG001', 'title': 'Asacol', 'description': '1.6g/day administered 800 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.061', 'spread': '1.1516', 'groupId': 'OG000'}, {'value': '0.059', 'spread': '1.2394', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 months', 'description': 'The modified UCDAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PP'}, {'type': 'SECONDARY', 'title': 'Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '155', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SPD476', 'description': '2.4 g/day QD'}, {'id': 'OG001', 'title': 'Asacol', 'description': '1.6g/day administered 800 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '59.523', 'spread': '8.7582', 'groupId': 'OG000'}, {'value': '59.664', 'spread': '7.7440', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 Months', 'description': 'Quality of life (QoL) was assessed using the SIBDQ. SIBDQ total score is calculated from the sum of 10 questions. Each question is scored on a scale from 1 (poor QoL) to 7 (good QoL) with total scores ranging from 10 to 70. Higher scores indicate better QoL.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat (ITT) population defined as all randomized subjects who received at least 1 dose of investigational product. Analysis includes patients who completed an SIBDQ questionnaire at 6 months.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SPD476', 'description': '2.4 g/day once daily (QD)'}, {'id': 'FG001', 'title': 'Asacol', 'description': '1.6g/day administered 800 mg twice daily (BID)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '416'}, {'groupId': 'FG001', 'numSubjects': '413'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '340'}, {'groupId': 'FG001', 'numSubjects': '330'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '83'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'Patient request', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Did not return for a visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Used prohibited corticosteroids', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of study medication at center', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '415', 'groupId': 'BG000'}, {'value': '411', 'groupId': 'BG001'}, {'value': '826', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'SPD476', 'description': '2.4 g/day QD'}, {'id': 'BG001', 'title': 'Asacol', 'description': '1.6g/day administered 800 mg BID'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.0', 'spread': '14.05', 'groupId': 'BG000'}, {'value': '45.2', 'spread': '13.44', 'groupId': 'BG001'}, {'value': '45.1', 'spread': '13.74', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Baseline characteristics were calculated from the Safety Population (n = 826) defined as all randomized subjects who received at least 1 dose of investigational product.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': '18 to 64 years', 'categories': [{'measurements': [{'value': '380', 'groupId': 'BG000'}, {'value': '377', 'groupId': 'BG001'}, {'value': '757', 'groupId': 'BG002'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline characteristics were calculated from the Safety Population (n = 826) defined as all randomized subjects who received at least 1 dose of investigational product.', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '203', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '400', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '212', 'groupId': 'BG000'}, {'value': '214', 'groupId': 'BG001'}, {'value': '426', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline characteristics were calculated from the Safety Population (n = 826) defined as all randomized subjects who received at least 1 dose of investigational product.', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Chile', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}, {'title': 'India', 'categories': [{'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '83', 'groupId': 'BG001'}, {'value': '164', 'groupId': 'BG002'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Peru', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Korea, Republic of', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}]}, {'title': 'Mexico', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}]}, {'title': 'Argentina', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Brazil', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Singapore', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'New Zealand', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Baseline characteristics were calculated from the Safety Population (n = 826) defined as all randomized subjects who received at least 1 dose of investigational product.', 'unitOfMeasure': 'Participants'}]}}, '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': 829}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2009-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-08', 'studyFirstSubmitDate': '2005-09-07', 'resultsFirstSubmitDate': '2010-08-26', 'studyFirstSubmitQcDate': '2005-09-07', 'lastUpdatePostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2010-08-26', 'studyFirstPostDateStruct': {'date': '2005-09-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months', 'timeFrame': '6 Months', 'description': 'Endoscopic remission is defined as an endoscopy score of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal \\[intact vascular pattern; no friability or granulation\\], 1 = mild \\[erythema; decreased vascular pattern; minimal granularity\\], 2 = moderate \\[marked erythema; granularity; friability; absent vascular pattern; bleeding with minimal trauma; no ulcerations\\], 3 = severe \\[ulceration; spontaneous bleeding\\].'}], 'secondaryOutcomes': [{'measure': 'Withdrawal Due to Relapse of UC', 'timeFrame': 'Over 6 Months', 'description': 'Relapse is defined as withdrawal from the study due to lack of efficacy.'}, {'measure': 'Endoscopic Remission of UC With No or Mild Symptoms at 6 Months', 'timeFrame': '6 Months', 'description': 'Endoscopic remission with no or mild symptoms is defined as an endoscopy score of less than or equal to 1 and a combined symptom score (stool frequency plus rectal bleeding) of less than or equal to 1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).'}, {'measure': 'Change From Baseline in Modified Ulcerative Colitis Disease Activity Index (UCDAI) Score at 6 Months', 'timeFrame': 'Baseline and 6 months', 'description': 'The modified UCDAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score.'}, {'measure': 'Short Inflammatory Bowel Disease Questionnaire (SIBDQ) Total Score', 'timeFrame': '6 Months', 'description': 'Quality of life (QoL) was assessed using the SIBDQ. SIBDQ total score is calculated from the sum of 10 questions. Each question is scored on a scale from 1 (poor QoL) to 7 (good QoL) with total scores ranging from 10 to 70. Higher scores indicate better QoL.'}]}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.lialda.com/Professional/pdf/pi.pdf', 'label': 'FDA-approved label'}, {'url': 'http://www.fda.gov/opacom/7alerts.html', 'label': 'FDA recall information'}]}, 'descriptionModule': {'briefSummary': 'Ulcerative colitis is a disease of the large bowel (colon) and rectum in which the lining of the bowel becomes red and swollen. Over time, patients with this disease may experience acute episodes of diarrhea, rectal bleeding and abdominal pain followed by periods of time without disease symptoms. 5-ASA drugs are a standard treatment for ulcerative colitis. Mesalazine is an experimental drug designed to gradually release 5-ASA into the areas of large bowel associated with ulcerative colitis. This study will test the safety and efficacy of mesalazine in keeping ulcerative colitis in remission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* previous diagnosis of ulcerative colitis confirmed by histology that has been considered to be in remission for =\\> 30 days\n* female subjects must be post-menopausal, surgically or biologically sterile, or with a negative urine pregnancy test at screening and on adequate contraception\n\nExclusion Criteria:\n\n* proctitis\n* previous resective colonic surgery\n* Crohn's disease\n* hypersensitivity to salicylates\n* moderate/severe renal impairment"}, 'identificationModule': {'nctId': 'NCT00151892', 'briefTitle': 'Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Phase III, Randomized 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