Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT00452335
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2007-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068238', 'term': 'Lubiprostone'}], 'ancestors': [{'id': 'D000527', 'term': 'Alprostadil'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@sucampo.com', 'phone': '301-961-3400', 'title': 'VP, Clinical Development', 'organization': 'Sucampo Pharma Americas, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent AEs: up to 4 weeks plus 7 days (from time of first dose to 7 days post-treatment)', 'eventGroups': [{'id': 'EG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight', 'otherNumAtRisk': 27, 'otherNumAffected': 5, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight', 'otherNumAtRisk': 65, 'otherNumAffected': 23, 'seriousNumAtRisk': 65, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight', 'otherNumAtRisk': 32, 'otherNumAffected': 14, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.1'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 65, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Frequency of Spontaneous Bowel Movements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'OG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'OG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}], 'classes': [{'categories': [{'measurements': [{'value': '2.47', 'spread': '2.68', 'groupId': 'OG000'}, {'value': '3.02', 'spread': '2.17', 'groupId': 'OG001'}, {'value': '3.84', 'spread': '2.51', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'description': 'Gathered as part of the daily electronic diary questions.', 'unitOfMeasure': 'spontaneous bowel movements per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population'}, {'type': 'SECONDARY', 'title': 'Frequency of Spontaneous Bowel Movements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'OG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'OG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}], 'classes': [{'title': 'Week 2', 'categories': [{'measurements': [{'value': '2.79', 'spread': '2.278', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '2.316', 'groupId': 'OG001'}, {'value': '3.51', 'spread': '1.897', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '2.64', 'spread': '2.210', 'groupId': 'OG000'}, {'value': '2.60', 'spread': '2.006', 'groupId': 'OG001'}, {'value': '3.58', 'spread': '2.422', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.85', 'spread': '2.130', 'groupId': 'OG000'}, {'value': '2.68', 'spread': '2.258', 'groupId': 'OG001'}, {'value': '2.99', 'spread': '1.827', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 3, and 4', 'description': 'Gathered as part of the daily electronic diary questions.', 'unitOfMeasure': 'spontaneous bowel movements per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Frequency of Fecal Incontinence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'OG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'OG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.53', 'spread': '1.141', 'groupId': 'OG000'}, {'value': '0.22', 'spread': '0.489', 'groupId': 'OG001'}, {'value': '0.03', 'spread': '0.089', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.37', 'spread': '0.768', 'groupId': 'OG000'}, {'value': '0.21', 'spread': '0.446', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.148', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.989', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.336', 'groupId': 'OG001'}, {'value': '0.01', 'spread': '0.060', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.48', 'spread': '1.168', 'groupId': 'OG000'}, {'value': '0.17', 'spread': '0.457', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.074', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.', 'unitOfMeasure': 'episodes of fecal incontinence per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Straining Associated With SBMs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'OG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'OG002', 'title': '24 Mch BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.70', 'spread': '1.074', 'groupId': 'OG000'}, {'value': '1.34', 'spread': '1.001', 'groupId': 'OG001'}, {'value': '1.44', 'spread': '0.890', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.02', 'spread': '1.010', 'groupId': 'OG000'}, {'value': '1.22', 'spread': '0.868', 'groupId': 'OG001'}, {'value': '1.30', 'spread': '1.003', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '1.11', 'spread': '0.857', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '0.809', 'groupId': 'OG001'}, {'value': '1.16', 'spread': '1.130', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.887', 'groupId': 'OG000'}, {'value': '1.31', 'spread': '1.096', 'groupId': 'OG001'}, {'value': '0.97', 'spread': '1.089', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Bowel straining assessed based on the following scale: 0 = no straining, 1 = mild straining, 2 = moderate straining, 3 = severe straining, and 4 = very severe straining.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Stool Consistency of SBMs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'OG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'OG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '2.87', 'spread': '1.197', 'groupId': 'OG000'}, {'value': '3.20', 'spread': '1.168', 'groupId': 'OG001'}, {'value': '3.14', 'spread': '1.249', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '3.09', 'spread': '1.078', 'groupId': 'OG000'}, {'value': '2.90', 'spread': '1.198', 'groupId': 'OG001'}, {'value': '3.22', 'spread': '1.394', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '2.93', 'spread': '0.796', 'groupId': 'OG000'}, {'value': '3.31', 'spread': '1.121', 'groupId': 'OG001'}, {'value': '3.59', 'spread': '1.168', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '3.20', 'spread': '0.904', 'groupId': 'OG000'}, {'value': '2.96', 'spread': '1.160', 'groupId': 'OG001'}, {'value': '4.01', 'spread': '1.631', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Stool consistency was captured using the Bristol Stool Form Scale: 1 = Separate hard lumps like nuts, 2 = Sausage shaped but lumpy, 3 = Like a sausage but with cracks on surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges, 6 = Fluffy pieces with ragged edges, a mushy stool, and 7 = Watery, no solid pieces.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Abdominal Bloating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'OG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'OG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.800', 'groupId': 'OG000'}, {'value': '1.39', 'spread': '1.150', 'groupId': 'OG001'}, {'value': '1.79', 'spread': '0.876', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.929', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '1.027', 'groupId': 'OG001'}, {'value': '1.16', 'spread': '0.987', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '0.82', 'spread': '1.006', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.937', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '1.018', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.96', 'spread': '1.065', 'groupId': 'OG000'}, {'value': '1.04', 'spread': '0.865', 'groupId': 'OG001'}, {'value': '1.05', 'spread': '0.950', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Abdominal Discomfort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'OG001', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'OG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '0.84', 'spread': '0.800', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '1.134', 'groupId': 'OG001'}, {'value': '1.43', 'spread': '1.289', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.08', 'spread': '0.929', 'groupId': 'OG000'}, {'value': '0.93', 'spread': '0.918', 'groupId': 'OG001'}, {'value': '1.20', 'spread': '1.080', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.795', 'groupId': 'OG000'}, {'value': '0.90', 'spread': '0.892', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '1.204', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.87', 'spread': '0.869', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '0.915', 'groupId': 'OG001'}, {'value': '1.14', 'spread': '1.125', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Abdominal discomfort was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Pain Associated With SBMs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'OG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'OG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.56', 'spread': '1.051', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '0.970', 'groupId': 'OG001'}, {'value': '1.14', 'spread': '0.873', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '0.72', 'spread': '1.009', 'groupId': 'OG000'}, {'value': '1.06', 'spread': '0.758', 'groupId': 'OG001'}, {'value': '1.10', 'spread': '1.073', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '0.88', 'spread': '0.929', 'groupId': 'OG000'}, {'value': '0.91', 'spread': '0.915', 'groupId': 'OG001'}, {'value': '1.01', 'spread': '1.089', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '0.82', 'spread': '0.978', 'groupId': 'OG000'}, {'value': '1.07', 'spread': '1.047', 'groupId': 'OG001'}, {'value': '1.07', 'spread': '1.298', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Pain associated with SBMs was assessed based on the following scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = very severe pain.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Constipation Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'OG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'OG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.92', 'spread': '1.038', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.951', 'groupId': 'OG001'}, {'value': '1.79', 'spread': '0.917', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.46', 'spread': '0.977', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '0.945', 'groupId': 'OG001'}, {'value': '1.40', 'spread': '0.816', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '1.59', 'spread': '0.908', 'groupId': 'OG000'}, {'value': '1.36', 'spread': '1.055', 'groupId': 'OG001'}, {'value': '1.38', 'spread': '0.875', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '1.43', 'spread': '1.121', 'groupId': 'OG000'}, {'value': '1.28', 'spread': '1.031', 'groupId': 'OG001'}, {'value': '1.59', 'spread': '1.054', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}, {'type': 'SECONDARY', 'title': 'Treatment Effectiveness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'OG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'OG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}], 'classes': [{'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.27', 'groupId': 'OG001'}, {'value': '1.7', 'spread': '0.86', 'groupId': 'OG002'}]}]}, {'title': 'Week 2', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.28', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.24', 'groupId': 'OG001'}, {'value': '2.0', 'spread': '1.17', 'groupId': 'OG002'}]}]}, {'title': 'Week 3', 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.51', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.31', 'groupId': 'OG001'}, {'value': '1.8', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': 'Week 4', 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.22', 'groupId': 'OG001'}, {'value': '1.9', 'spread': '1.10', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Treatment effectiveness was assessed with the following scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, and 4 = extremely effective.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'FG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'FG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '65'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '61'}, {'groupId': 'FG002', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '9'}]}]}], 'preAssignmentDetails': '127 participants were randomized to study treatment, however only 124 participants received study drug'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': '12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight'}, {'id': 'BG001', 'title': '12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight'}, {'id': 'BG002', 'title': '24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '1.67', 'groupId': 'BG000'}, {'value': '10.3', 'spread': '2.78', 'groupId': 'BG001'}, {'value': '13.9', 'spread': '3.00', 'groupId': 'BG002'}, {'value': '10.2', 'spread': '3.91', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '124', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 127}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'dispFirstSubmitDate': '2009-10-21', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-13', 'studyFirstSubmitDate': '2007-03-26', 'dispFirstSubmitQcDate': '2009-10-21', 'resultsFirstSubmitDate': '2016-02-16', 'studyFirstSubmitQcDate': '2007-03-26', 'dispFirstPostDateStruct': {'date': '2010-02-19', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-07-12', 'studyFirstPostDateStruct': {'date': '2007-03-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of Spontaneous Bowel Movements', 'timeFrame': 'Week 1', 'description': 'Gathered as part of the daily electronic diary questions.'}], 'secondaryOutcomes': [{'measure': 'Frequency of Spontaneous Bowel Movements', 'timeFrame': 'Weeks 2, 3, and 4', 'description': 'Gathered as part of the daily electronic diary questions.'}, {'measure': 'Frequency of Fecal Incontinence', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'As part of the daily diary, patients were asked to report the number of fecal incontinence episodes per day.'}, {'measure': 'Straining Associated With SBMs', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Bowel straining assessed based on the following scale: 0 = no straining, 1 = mild straining, 2 = moderate straining, 3 = severe straining, and 4 = very severe straining.'}, {'measure': 'Stool Consistency of SBMs', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Stool consistency was captured using the Bristol Stool Form Scale: 1 = Separate hard lumps like nuts, 2 = Sausage shaped but lumpy, 3 = Like a sausage but with cracks on surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges, 6 = Fluffy pieces with ragged edges, a mushy stool, and 7 = Watery, no solid pieces.'}, {'measure': 'Abdominal Bloating', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Abdominal bloating was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.'}, {'measure': 'Abdominal Discomfort', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Abdominal discomfort was assessed based on the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.'}, {'measure': 'Pain Associated With SBMs', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Pain associated with SBMs was assessed based on the following scale: 0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain, and 4 = very severe pain.'}, {'measure': 'Constipation Severity', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Constipation severity was assessed based on the following scale 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.'}, {'measure': 'Treatment Effectiveness', 'timeFrame': 'Weekly, up to 4 weeks', 'description': 'Treatment effectiveness was assessed with the following scale: 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, and 4 = extremely effective.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the safety and efficacy of lubiprostone in a pediatric population with constipation, including the pharmacokinetics of lubiprostone, in a subset of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Less than 18 years of age\n* Weight of at least 12 kg and capable of swallowing a capsule\n* Able to refrain from use of medications known to treat or associated with constipation symptoms\n* Stable fiber therapy or ADHD therapy if using such medications\n* Patient/Caregiver able to complete daily diary\n* Patient able to use recommended rectal and/or oral rescue medications if needed\n\nExclusion Criteria:\n\n* Constipation is associated with some medical, anatomic, physical, organic, or other condition\n* Hirschsprung's Disease or Nonretentive Fecal Incontinence\n* Untreated fecal impactions or impactions requiring digital manipulation\n* Open gastrointestinal/abdominal surgery or laparoscopic surgery at the investigator discretion\n* Organic bowel disorder, mechanical bowel obstruction, pseudo-obstruction, or unexplained weight loss\n* Uncontrolled cardiovascular, liver or lung disease, neurologic or psychiatric disorder, other systemic disease, or abnormal laboratory tests at the investigator discretion\n* If female, is currently pregnant or nursing, or plans to become pregnant or nurse during the clinical study\n* Sexually active males and females must utilize acceptable birth control methods\n* Prior use of lubiprostone, Amitiza, SPI-0211, or RU-0211"}, 'identificationModule': {'nctId': 'NCT00452335', 'briefTitle': 'Safety and Efficacy of Lubiprostone in Pediatric Patients With Constipation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mallinckrodt'}, 'officialTitle': 'A Multi-center, Open-labeled Study of the Safety, Efficacy, and Pharmacokinetics of Lubiprostone in Pediatric Patients With Constipation', 'orgStudyIdInfo': {'id': '0211SC-0641'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lubiprostone 12 mcg QD', 'description': 'Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (\\<6 years of age and able to swallow capsules) who are at least 12 kg body weight', 'interventionNames': ['Drug: Lubiprostone']}, {'type': 'EXPERIMENTAL', 'label': 'Lubiprostone 12 mcg BID', 'description': 'Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight', 'interventionNames': ['Drug: Lubiprostone']}, {'type': 'EXPERIMENTAL', 'label': 'Lubiprostone 24 mcg BID', 'description': 'Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight', 'interventionNames': ['Drug: Lubiprostone']}], 'interventions': [{'name': 'Lubiprostone', 'type': 'DRUG', 'otherNames': ['Amitiza®'], 'description': '12 mcg capsule once daily (QD)', 'armGroupLabels': ['Lubiprostone 12 mcg QD']}, {'name': 'Lubiprostone', 'type': 'DRUG', 'otherNames': ['Amitiza®'], 'description': '12 mcg capsule twice daily (BID)', 'armGroupLabels': ['Lubiprostone 12 mcg BID']}, {'name': 'Lubiprostone', 'type': 'DRUG', 'otherNames': ['Amitiza®'], 'description': '24 mcg capsule twice daily (BID)', 'armGroupLabels': ['Lubiprostone 24 mcg BID']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Phoenix Children's Hospital", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '72005', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Pediatric Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital and Research Center Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic - Jacksonville", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '32504', 'city': 'Pensacola', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic - Pensacola", 'geoPoint': {'lat': 30.42131, 'lon': -87.21691}}, {'zip': '60068', 'city': 'Park Ridge', 'state': 'Illinois', 'country': 'United States', 'facility': "Center for Children's Digestive Health", 'geoPoint': {'lat': 42.01114, 'lon': -87.84062}}, {'zip': '61613', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Peoria', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '62708-0787', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'The Center for Human Nutrition, Inc.', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'AHS Hospital Corporation', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '43205', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': "Children's Research Institute", 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45014', 'city': 'Fairfield', 'state': 'Ohio', 'country': 'United States', 'facility': 'Pediatric Associates of Fairfield, Inc.', 'geoPoint': {'lat': 39.34589, 'lon': -84.5605}}, {'zip': '17604', 'city': 'Lancaster', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Regional Gastroenterology Associates of Lancaster, Ltd.', 'geoPoint': {'lat': 40.03788, 'lon': -76.30551}}, {'zip': '37403', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southeastern Clinical Research', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '38305', 'city': 'Jackson', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Jackson Clinic', 'geoPoint': {'lat': 35.61452, 'lon': -88.81395}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Paul Hyman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sucampo Pharma Americas, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sucampo Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}