Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT00297167
Status:
COMPLETED
Last Update Posted:
2017-03-16
First Post:
2006-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D010188', 'term': 'Exocrine Pancreatic Insufficiency'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1- 800- 472- 2634', 'title': 'Robert Winkler, MD, VP, Clinical Development and Operations', 'organization': 'Aptalis Pharma US, Inc.'}, 'certainAgreement': {'otherDetails': "Restrictions may vary in accordance with each agreement that is negotiated with individual investigators. Sponsor will allow publication after multi-center publication has been published or after an agreed period of time if no such multi-center publication is submitted for publication. Sponsor can ask that Sponsor's confidential information be removed from any publication and defer publication for period of time to allow Sponsor to obtain patent or other intellectual property right protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse event (AE) was defined as any untoward medical occurrence regardless of causal relationship to study medication. Serious adverse event (SAE) was any event that resulted in death,life threatening,required or prolonged in-patient hospitalization,significant disability/incapacity,or was a congenital anomaly/birth defect or assessed as important medical event.', 'eventGroups': [{'id': 'EG000', 'title': 'EUR-1008 (APT-1008)', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. Participants received EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily at a fixed stabilized dose for 5 to 14 days during open-label dose normalization period 1 and for 7 days during open-label dose normalization period 2 which was maintained after each double-blind intervention period. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (units/kg/day).", 'otherNumAtRisk': 34, 'otherNumAffected': 19, 'seriousNumAtRisk': 34, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.", 'otherNumAtRisk': 32, 'otherNumAffected': 16, 'seriousNumAtRisk': 32, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal discomfort', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Abdominal distension', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Abdominal pain', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Abdominal pain upper', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Abnormal faeces', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Flatulence', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Frequent bowel movements', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Nausea', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Steatorrhoea', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Vomiting', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Early satiety', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Contusion', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Injury', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Weight decreased', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Headache', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Cough', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Nasal congestion', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Abdominal tenderness', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Bowel sounds abnormal', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Constipation', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Infrequent bowel movements', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Chest pain', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Oedema mucosal', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Pyrexia', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Otitis externa', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Anal injury', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Fall', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Anorexia', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Clubbing', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Dizziness', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Vaginal burning sensation', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Crackles lung', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Rash', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Haematoma', 'notes': 'These data represent AEs collected during both double blind treatment periods.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}], 'seriousEvents': [{'term': 'Haemoptysis', 'notes': 'SAEs for EUR-1008 occurred during the first open-label dose stabilization period, during which all participants were on EUR-1008.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}, {'term': 'Lung disorder', 'notes': 'SAEs for EUR-1008 occurred during the first open-label dose stabilization period, during which all participants were on EUR-1008.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Coefficient of Fat Absorption (CFA%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUR-1008 (APT-1008)', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '88.28', 'spread': '2.599', 'groupId': 'OG000'}, {'value': '62.76', 'spread': '2.639', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Square (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-25.52', 'ciLowerLimit': '-31.73', 'ciUpperLimit': '-19.32', 'groupDescription': 'P-Value was calculated using analysis of variance (ANOVA) model which included main effects for treatment and sequence and participant nested in sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods', 'description': 'Percent CFA was calculated as (\\[fat intake - fat excretion\\]/fat intake)multiplied by 100, determined in the stools collected during the 72-hour hospitalization period. Mean percent CFA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind (DB) intervention periods.', 'unitOfMeasure': 'percent CFA', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here "N" (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percent Coefficient of Nitrogen Absorption (CNA%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUR-1008 (APT-1008)', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '87.17', 'spread': '2.179', 'groupId': 'OG000'}, {'value': '65.67', 'spread': '2.213', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-21.50', 'ciLowerLimit': '-26.85', 'ciUpperLimit': '-16.14', 'groupDescription': 'P-Value was calculated using analysis of variance (ANOVA)model which included main effects for treatment and sequence and participant nested in sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods', 'description': 'Percent CNA was calculated as (\\[nitrogen intake-nitrogen excretion\\]/nitrogen intake)\\*100, determined in the stools collected during the 72-hour hospitalization period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind intervention periods.', 'unitOfMeasure': 'percent CNA', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period. Here "N" (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Lipid Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUR-1008 (APT-1008)', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment."}], 'classes': [{'title': 'TC: End of Treatment (n=33, 30)', 'categories': [{'measurements': [{'value': '128.8', 'spread': '28.98', 'groupId': 'OG000'}, {'value': '109.1', 'spread': '29.76', 'groupId': 'OG001'}]}]}, {'title': 'HDL-C: End of Treatment (n=33, 30)', 'categories': [{'measurements': [{'value': '45.5', 'spread': '10.85', 'groupId': 'OG000'}, {'value': '37.2', 'spread': '9.23', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of treatment (Day 6 during first and second double-blind intervention periods)', 'description': 'Lipid levels were reported for total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C) from fasted blood and urine samples. Mean lipid levels for Day 6 during first and second double-blind intervention periods were calculated.', 'unitOfMeasure': 'milligram/deciliter (mg/dL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure and "n" signifies participants who were evaluable at specific time point in each treatment arm.'}, {'type': 'SECONDARY', 'title': 'Vitamin A Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUR-1008 (APT-1008)', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '422.3', 'spread': '111.67', 'groupId': 'OG000'}, {'value': '363.2', 'spread': '100.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of treatment (Day 6 during first and second double-blind intervention periods)', 'description': 'Mean Vitamin A levels for Day 6 during first and second double-blind intervention periods were calculated.', 'unitOfMeasure': 'microgram per liter (mcg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Vitamin E Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUR-1008 (APT-1008)', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '8.25', 'spread': '3.115', 'groupId': 'OG000'}, {'value': '6.69', 'spread': '2.648', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of treatment (Day 6 during first and second double-blind intervention periods)', 'description': 'Mean Vitamin E levels for Day 6 during first and second double-blind intervention periods were calculated.', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment. Here "N" (number of participants analyzed) signifies number of participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Mean Daily Number of Stools', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUR-1008 (APT-1008)', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '1.76', 'spread': '0.898', 'groupId': 'OG000'}, {'value': '2.66', 'spread': '1.418', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 up to Day 6 during first and second double-blind intervention periods', 'description': 'Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 3 to Day 6 in first and second double-blind intervention periods) for total participants was summarized.', 'unitOfMeasure': 'stools per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.'}, {'type': 'SECONDARY', 'title': 'Percentage of Stool Categorized as Per Consistency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUR-1008 (APT-1008)', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment."}], 'classes': [{'title': 'Hard', 'categories': [{'measurements': [{'value': '16.54', 'spread': '29.637', 'groupId': 'OG000'}, {'value': '6.24', 'spread': '18.845', 'groupId': 'OG001'}]}]}, {'title': 'Formed/Normal', 'categories': [{'measurements': [{'value': '53.86', 'spread': '37.253', 'groupId': 'OG000'}, {'value': '33.25', 'spread': '34.414', 'groupId': 'OG001'}]}]}, {'title': 'Soft', 'categories': [{'measurements': [{'value': '29.24', 'spread': '34.096', 'groupId': 'OG000'}, {'value': '57.11', 'spread': '36.105', 'groupId': 'OG001'}]}]}, {'title': 'Watery', 'categories': [{'measurements': [{'value': '0.36', 'spread': '1.421', 'groupId': 'OG000'}, {'value': '2.59', 'spread': '4.836', 'groupId': 'OG001'}]}]}, {'title': 'Overt diarrhea', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.82', 'spread': '3.670', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 up to Day 6 during first and second double-blind intervention periods', 'description': 'Stool consistency was categorized as hard, formed/normal, soft, watery, or overt diarrhea. Percentage of stools of a specific consistency for each participant at first and second double-blind intervention periods was calculated. Mean percentage of stool consistency during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized.', 'unitOfMeasure': 'percentage of stools', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.'}, {'type': 'SECONDARY', 'title': 'Mean Number of Abdominal Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUR-1008 (APT-1008)', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment."}], 'classes': [{'title': 'Bloating: Mild', 'categories': [{'measurements': [{'value': '0.10', 'spread': '0.300', 'groupId': 'OG000'}, {'value': '0.31', 'spread': '0.718', 'groupId': 'OG001'}]}]}, {'title': 'Bloating: Moderate', 'categories': [{'measurements': [{'value': '0.05', 'spread': '0.191', 'groupId': 'OG000'}, {'value': '0.10', 'spread': '0.329', 'groupId': 'OG001'}]}]}, {'title': 'Bloating: Severe', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.495', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence: Mild', 'categories': [{'measurements': [{'value': '0.40', 'spread': '0.688', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '1.134', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence: Moderate', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.275', 'groupId': 'OG000'}, {'value': '0.41', 'spread': '1.160', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence: Severe', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.000', 'groupId': 'OG000'}, {'value': '0.18', 'spread': '0.719', 'groupId': 'OG001'}]}]}, {'title': 'Pain: Mild', 'categories': [{'measurements': [{'value': '0.16', 'spread': '0.433', 'groupId': 'OG000'}, {'value': '0.62', 'spread': '0.901', 'groupId': 'OG001'}]}]}, {'title': 'Pain: Moderate', 'categories': [{'measurements': [{'value': '0.08', 'spread': '0.379', 'groupId': 'OG000'}, {'value': '0.32', 'spread': '0.754', 'groupId': 'OG001'}]}]}, {'title': 'Pain: Severe', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.022', 'groupId': 'OG000'}, {'value': '0.09', 'spread': '0.228', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 up to Day 6 during first and second double-blind intervention periods', 'description': 'Abdominal symptoms included abdominal pain, flatulence and bloating. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptom of specific severity per day for each participant was calculated. Mean number of symptoms per day was calculated for Day 3 to Day 6 in first and second double-blind intervention periods for total participants.', 'unitOfMeasure': 'symptoms per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Visible Oil or Grease in Stool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUR-1008 (APT-1008)', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '6.78', 'spread': '17.354', 'groupId': 'OG000'}, {'value': '27.97', 'spread': '33.571', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods', 'description': 'Mean percentage of stools with visible oil or grease during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with visible oil or grease divided by the total number of stool per day.', 'unitOfMeasure': 'percentage of visible oil or grease/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Percentage of Stools With Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EUR-1008 (APT-1008)', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day."}, {'id': 'OG001', 'title': 'Placebo', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment."}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'spread': '0.174', 'groupId': 'OG000'}, {'value': '1.13', 'spread': '4.647', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods', 'description': 'Mean percentage of stools with blood during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with blood divided by the total number of stool per day.', 'unitOfMeasure': 'percentage of stools with blood per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Efficacy analysis population included all randomized and treated participants with at least 1 post-baseline measurement for each double-blind intervention period.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo First, Then EUR-1008 (APT-1008)', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first double-blind intervention period followed by EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (lipase units/kg/day)."}, {'id': 'FG001', 'title': 'EUR-1008 (APT-1008) First, Then Placebo', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first double-blind intervention period followed by placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day."}, {'id': 'FG002', 'title': 'EUR-1008 (APT-1008) (Open-label)', 'description': 'EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily at a fixed stabilized dose during open-label normalization period 1 (5 to 14 days) after first double-blind interventional period and during open-label normalization period 2 (7 days) after second double-blind interventional period.'}], 'periods': [{'title': 'First Double-blind Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '16'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open-label Dose Normalization Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Second Double-blind Intervention Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Open-label Dose Normalization Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Out of 34 participants who were enrolled and treated during open-label dose titration and stabilization period, 1 participant withdrew from the study before randomization to first double-blind intervention period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes participants who received EUR-1008 (APT-1008) in open-label dose titration and stabilization phase; and EUR-1008 (APT-1008) first and placebo first after randomization to study treatment.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'spread': '4.75', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety population included all participants who received at least 1 dose of study treatment.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-07', 'studyFirstSubmitDate': '2006-02-27', 'resultsFirstSubmitDate': '2014-02-24', 'studyFirstSubmitQcDate': '2006-02-27', 'lastUpdatePostDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-02-24', 'studyFirstPostDateStruct': {'date': '2006-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Percentage of Visible Oil or Grease in Stool', 'timeFrame': 'Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods', 'description': 'Mean percentage of stools with visible oil or grease during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with visible oil or grease divided by the total number of stool per day.'}, {'measure': 'Percentage of Stools With Blood', 'timeFrame': 'Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods', 'description': 'Mean percentage of stools with blood during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized. Percentage was calculated as the number of stools with blood divided by the total number of stool per day.'}], 'primaryOutcomes': [{'measure': 'Percent Coefficient of Fat Absorption (CFA%)', 'timeFrame': 'Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods', 'description': 'Percent CFA was calculated as (\\[fat intake - fat excretion\\]/fat intake)multiplied by 100, determined in the stools collected during the 72-hour hospitalization period. Mean percent CFA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind (DB) intervention periods.'}], 'secondaryOutcomes': [{'measure': 'Percent Coefficient of Nitrogen Absorption (CNA%)', 'timeFrame': 'Day 3 up to Day 6 of hospital treatment in first and second double-blind intervention periods', 'description': 'Percent CNA was calculated as (\\[nitrogen intake-nitrogen excretion\\]/nitrogen intake)\\*100, determined in the stools collected during the 72-hour hospitalization period. Nitrogen intake was calculated as protein intake/6.2. Nitrogen excretion was measured as total fecal nitrogen. Mean percent CNA was calculated for Day 3 to Day 6 during hospital treatment in first and second double-blind intervention periods.'}, {'measure': 'Lipid Levels', 'timeFrame': 'End of treatment (Day 6 during first and second double-blind intervention periods)', 'description': 'Lipid levels were reported for total cholesterol (TC) and high-density lipoprotein cholesterol (HDL-C) from fasted blood and urine samples. Mean lipid levels for Day 6 during first and second double-blind intervention periods were calculated.'}, {'measure': 'Vitamin A Levels', 'timeFrame': 'End of treatment (Day 6 during first and second double-blind intervention periods)', 'description': 'Mean Vitamin A levels for Day 6 during first and second double-blind intervention periods were calculated.'}, {'measure': 'Vitamin E Levels', 'timeFrame': 'End of treatment (Day 6 during first and second double-blind intervention periods)', 'description': 'Mean Vitamin E levels for Day 6 during first and second double-blind intervention periods were calculated.'}, {'measure': 'Mean Daily Number of Stools', 'timeFrame': 'Day 3 up to Day 6 during first and second double-blind intervention periods', 'description': 'Mean daily number of stools of each participant was calculated from frequency of stools by the participant per day. Mean daily number of stools during the collection period (Day 3 to Day 6 in first and second double-blind intervention periods) for total participants was summarized.'}, {'measure': 'Percentage of Stool Categorized as Per Consistency', 'timeFrame': 'Day 3 up to Day 6 during first and second double-blind intervention periods', 'description': 'Stool consistency was categorized as hard, formed/normal, soft, watery, or overt diarrhea. Percentage of stools of a specific consistency for each participant at first and second double-blind intervention periods was calculated. Mean percentage of stool consistency during the collection period (Day 3 to Day 6 in first and second intervention periods) for total participants was summarized.'}, {'measure': 'Mean Number of Abdominal Symptoms', 'timeFrame': 'Day 3 up to Day 6 during first and second double-blind intervention periods', 'description': 'Abdominal symptoms included abdominal pain, flatulence and bloating. Symptoms were classified by severity as mild (no impairment of daily activities), moderate (slight impairment of daily activities), or severe (unable to perform daily activities). Mean number of symptom of specific severity per day for each participant was calculated. Mean number of symptoms per day was calculated for Day 3 to Day 6 in first and second double-blind intervention periods for total participants.'}]}, 'conditionsModule': {'keywords': ['CF', 'Cystic Fibrosis', 'EPI', 'Exocrine Pancreatic Insufficiency', 'Pancreatic', 'Enzyme', 'PEP'], 'conditions': ['Cystic Fibrosis', 'Exocrine Pancreatic Insufficiency']}, 'referencesModule': {'references': [{'pmid': '19683970', 'type': 'DERIVED', 'citation': 'Wooldridge JL, Heubi JE, Amaro-Galvez R, Boas SR, Blake KV, Nasr SZ, Chatfield B, McColley SA, Woo MS, Hardy KA, Kravitz RM, Straforini C, Anelli M, Lee C. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibros. 2009 Dec;8(6):405-17. doi: 10.1016/j.jcf.2009.07.006. Epub 2009 Aug 15.'}]}, 'descriptionModule': {'briefSummary': "The primary efficacy objective of this study is to compare the coefficient of fat absorption (CFA) following oral administration of Aptalis Pharma's (formerly Eurand Pharmaceuticals) pancreatic enzyme product (PEP) capsules and placebo in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).", 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled, 2-treatment, crossover, multicenter trial in participants with CF and EPI. The study consists of a screening period (1 to 14 days), a washout period (2 days), a dose titration/stabilization period (6 to 9 days), a blinded randomized treatment period (6 to 7 days), an open-label normalization period 1 (5 to 14 days), a blinded crossover treatment period (6 to 7 days), followed by an open-label normalization period 2 (7 days). The order of treatments (placebo followed by EUR-1008 \\[APT-1008\\] or EUR-1008 \\[APT-1008\\] followed by placebo) will be determined by randomization at the beginning of randomization treatment period only and will be carried through the crossover treatment period. The starting dose will be 1,000 lipase units per kilogram per meal (lipase units/kg/meal), which will be titrated to control symptoms of EPI, with the total dose not exceeding 10,000 lipase units/kg/day.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants with age greater than or equal to (\\>=) 7 years at the time of enrollment\n* Participants with weight 70 kg or less and be in an adequate nutritional status as indicated by a body mass index (BMI) \\>=20 kg/m\\^2 for ages 18 and above, or a BMI above the twenty fifth percentile for participants aged 7 to 17 years\n* Participants with confirmed diagnosis of CF who have 2 clinical features consistent with CF, and have either a genotype with 2 identifiable mutations consistent with CF or a sweat chloride concentration that is more than 60 milliequivalent per liter by quantitative pilocarpine iontophoresis\n* Participants with confirmed diagnosis of EPI who are currently receiving treatment with a commercially available PEP and have documented with a fecal elastase of \\<100 microgram per gram stool (if no documentation was available, a stool sample was taken at Screening for determination of fecal elastase).\n* Clinically stable participants with no evidence of acute respiratory disease or any other acute condition\n* Participants who are willing and able to interrupt current CF treatment for CF-related malabsorption along with any medications that may affect gastric motility or stomach power of hydrogen (pH)\n* Participants 18 years of age and older had to a) understand the requirements of the study, b) provide written informed consent, c) agree to abide by the study restrictions, and d) return for the required assessments\n* Participants 7 to 17 years of age must have a parent(s) or legal guardian who provides written informed consent, agree to abide by the study restrictions\n* Females participants of childbearing potential must have a negative serum pregnancy test at screening and must agree to use adequate birth control during the study\n\nExclusion Criteria:\n\n* Participants with fibrosing colonopathy, hyperuricemia or hyperuricosuria\n* Participants who are allergic to pork or other porcine PEPs\n* Participants with forced expiratory volume (FEV1) \\<30 percent of predicted FEV1 at screening\n* Participants with any acute systemic administration of an antibiotic for any reason in the previous 4 weeks; however, a low stable dose of an antibiotic or chronic treatment with an inhalatory antibiotic is allowed\n* Participants with hepatic insufficiency as defined by history or presence of ascites or serum albumin level of \\< 3.0 milligram/deciliter, or a coagulopathy with an international normalized ratio that is greater than 1.7\n* Participants who have used an acute dose of any steroid in the previous 2 weeks; however, low chronic doses of a steroid is allowed\n* Participants with history of or current diagnosis of distal ileal obstruction syndrome (DIOS) as evidenced or suggested by constipation, abdominal pain, anorexia, early satiety, recurrent vomiting, and palpable fecal mass on physical examination (the absence of DIOS will be confirmed by an X-ray of the abdomen taken at screening)\n* Participants with any solid organ transplant or surgery affecting the bowel. Participants with a history of appendectomy and inguinal (non-incarcerated) hernioplasty or meconium ileus without the need for bowel resection could be enrolled. Gastrointestinal-tube-fed patients, in absence of dumping syndrome, were also eligible\n* Participants with history of or current screening evaluation of hyperglycemia as defined by an 8-hour fasting blood glucose (FBG) of \\>126 mg/dL, or of CF-related diabetes as determined according to the Cystic Fibrosis Foundation (CFF) Consensus Conference of January 1999 (Section IX Part II), that is: a) FBG \\>126 mg/dL (7.0 millimoles per liter \\[mmol/L\\]) on two or more occasions b)FBG \\>126 mg/dL (7.0 mmol/L) plus casual (without regard to time of day or last meal consumed) glucose level \\>200 mg/dL (11.1 mmol/L) c)Casual (previously called random) glucose levels \\>200 mg/dL (11.1 mmol/L) on two or more occasions with symptoms\n* Participants using an enzyme preparation in excess of 10,000-lipase units/kg/day\n* Participants using an immunosuppressive drug\n* Participants who are expecting an inability to tolerate the washout period and/or the placebo treatment\n* Participants participating in an investigational study of a drug, biologic, or device not currently approved for marketing, within 30 days of screening visit\n* Female participants who are pregnant or breastfeeding, or unwilling to use effective birth control during study\n* Participants with any condition that would, in the investigator's opinion, limit the participant's ability to complete the study"}, 'identificationModule': {'nctId': 'NCT00297167', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency', 'orgStudyIdInfo': {'id': 'EUR-1008-M'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EUR-1008 (APT-1008) First, Then Placebo', 'interventionNames': ['Drug: EUR-1008 (APT-1008)', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo First, Then EUR-1008 (APT-1008)', 'interventionNames': ['Drug: Placebo', 'Drug: EUR-1008 (APT-1008)']}], 'interventions': [{'name': 'EUR-1008 (APT-1008)', 'type': 'DRUG', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.", 'armGroupLabels': ['EUR-1008 (APT-1008) First, Then Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.", 'armGroupLabels': ['EUR-1008 (APT-1008) First, Then Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': "Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule will be given orally daily in first double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for first double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.", 'armGroupLabels': ['Placebo First, Then EUR-1008 (APT-1008)']}, {'name': 'EUR-1008 (APT-1008)', 'type': 'DRUG', 'description': "EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule will be given orally daily in second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for second double-blind intervention period will be 2 days home treatment and 3 to 5 days hospital treatment.", 'armGroupLabels': ['Placebo First, Then EUR-1008 (APT-1008)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75708', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Center at Tyler', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}], 'overallOfficials': [{'name': 'Aptalis Medical Information', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Forest Laboratories'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}