Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT00690820
Status:
COMPLETED
Last Update Posted:
2010-06-02
First Post:
2008-06-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)
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': {'email': 'sven.voet@solvay.com', 'phone': '+32(0)2 509 69 77', 'title': 'Sven Voet - Global Communication', 'organization': 'Solvay Pharmaceuticals'}, 'certainAgreement': {'otherDetails': 'At 60 days prior to submitting or presenting a manuscript or other materials relating to the study to a publisher, reviewer or outside persons, the Site shall provide to Sponsor a copy and allow Sponsor 60 days to review and comment.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The adverse events were collected from Screening to the end of the second period of the cross-over trial. A safety follow-up call was performed 5-7 days after the last visit to the clinic.', 'description': 'Only Treatment Emergent Adverse events are presented.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Placebo treatment', 'otherNumAtRisk': 16, 'otherNumAffected': 9, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pancrelipase', 'description': 'Pancrelipase delayed release 12000 units treatment', 'otherNumAtRisk': 17, 'otherNumAffected': 5, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rectal Discharge', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Faecal Volume Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Frequent Bowel Movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Blood glucose increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Weight Decrease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Cold sweat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Rash Macular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 8.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Coefficient of Fat Absorption (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo treatment'}, {'id': 'OG001', 'title': 'Pancrelipase', 'description': 'Pancrelipase delayed release 12000 units treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '47.41', 'spread': '16.84', 'groupId': 'OG000'}, {'value': '82.81', 'spread': '8.29', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'This coefficient is calculated from fat intake and fat excretion : 100\\*\\[fat intake-fat excretion\\]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Coefficient of Nitrogen Absorption (%)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo treatment'}, {'id': 'OG001', 'title': 'Pancrelipase', 'description': 'Pancrelipase delayed release 12000 units treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '44.98', 'spread': '20.47', 'groupId': 'OG000'}, {'value': '80.33', 'spread': '7.92', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'This coefficient is calculated from nitrogen intake and nitrogen excretion : 100\\*\\[nitrogen intake-nitrogen excretion\\]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Total Fat Excretion (Grams)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo treatment'}, {'id': 'OG001', 'title': 'Pancrelipase', 'description': 'Pancrelipase delayed release 12000 units treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '182.9', 'spread': '68.0', 'groupId': 'OG000'}, {'value': '58.1', 'spread': '27.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.', 'unitOfMeasure': 'Grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Total Stool Weight (Grams)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo treatment'}, {'id': 'OG001', 'title': 'Pancrelipase', 'description': 'Pancrelipase delayed release 12000 units treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '436.5', 'spread': '158.4', 'groupId': 'OG000'}, {'value': '161.4', 'spread': '57.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.', 'unitOfMeasure': 'Grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Stool Frequency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo treatment'}, {'id': 'OG001', 'title': 'Pancrelipase', 'description': 'Pancrelipase delayed release 12000 units treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '3.46', 'spread': '1.06', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.', 'unitOfMeasure': 'Number per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days With no Flatulence.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo treatment'}, {'id': 'OG001', 'title': 'Pancrelipase', 'description': 'Pancrelipase delayed release 12000 units treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '36.3', 'spread': '36.9', 'groupId': 'OG000'}, {'value': '45.0', 'spread': '42.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.671', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'The percentage of days with no flatulence is calculated from the diary during the treatment period: 100\\*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.', 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days With Formed/Normal Stools.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo treatment'}, {'id': 'OG001', 'title': 'Pancrelipase', 'description': 'Pancrelipase delayed release 12000 units treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '38.9', 'spread': '33.0', 'groupId': 'OG000'}, {'value': '77.7', 'spread': '27.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100\\*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.', 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Days With no Abdominal Pain.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Placebo treatment'}, {'id': 'OG001', 'title': 'Pancrelipase', 'description': 'Pancrelipase delayed release 12000 units treatment'}], 'classes': [{'categories': [{'measurements': [{'value': '65.2', 'spread': '28.9', 'groupId': 'OG000'}, {'value': '85.3', 'spread': '21.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'groupDescription': 'The parameter was analyzed using an analysis of variance (ANOVA) including treatment, sequence and period as fixed effect and subject within sequence as a random effect.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '5 days', 'description': 'The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100\\*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.', 'unitOfMeasure': 'Percentage of days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis was done on the Full Analysis Sample defined as the randomized subjects with at least one post-baseline efficacy measurement.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo/Pancrelipase', 'description': 'Placebo period followed by Pancrelipase delayed release 12000 units period'}, {'id': 'FG001', 'title': 'Pancrelipase/Placebo', 'description': 'Pancrelipase delayed release 12000 units period followed by Placebo period'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects were recruited in 10 centers in US between June 2008 and October 2008. Before the randomization, subjects were evaluated for eligibility. They underwent a short period of up to 14 days on their usual pancreatic enzyme supplementation.', 'preAssignmentDetails': 'Twenty three subjects had given their consent and 17 subjects were randomly allocated to pancrelipase/placebo or placebo/pancrelipase. One subject did not complete the first period of the treatment (consent withdrawal).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo/Pancrelipase', 'description': 'Placebo period followed by Pancrelipase delayed release 12000 units period'}, {'id': 'BG001', 'title': 'Pancrelipase/Placebo', 'description': 'Pancrelipase delayed release 12000 units period followed by Placebo period'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '8.9', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '8.7', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '8.8', 'spread': '1.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-26', 'studyFirstSubmitDate': '2008-06-03', 'resultsFirstSubmitDate': '2009-11-30', 'studyFirstSubmitQcDate': '2008-06-04', 'lastUpdatePostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-02-03', 'studyFirstPostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Coefficient of Fat Absorption (%)', 'timeFrame': '5 days', 'description': 'This coefficient is calculated from fat intake and fat excretion : 100\\*\\[fat intake-fat excretion\\]/fat intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.'}], 'secondaryOutcomes': [{'measure': 'Coefficient of Nitrogen Absorption (%)', 'timeFrame': '5 days', 'description': 'This coefficient is calculated from nitrogen intake and nitrogen excretion : 100\\*\\[nitrogen intake-nitrogen excretion\\]/nitrogen intake. Stools were collected on 3 days during the 5 days treatment period. Higher values indicate a better response.'}, {'measure': 'Total Fat Excretion (Grams)', 'timeFrame': '5 days', 'description': 'Total amount of fat excreted during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.'}, {'measure': 'Total Stool Weight (Grams)', 'timeFrame': '5 days', 'description': 'Total weight of the stools collected during the stool collection period. Stools were collected on 3 days during the 5 days treatment period. Lower values indicate a better response.'}, {'measure': 'Stool Frequency', 'timeFrame': '5 days', 'description': 'Stool frequency is the average of the daily number of stools recorded during the treatment period. Lower values indicate a better response.'}, {'measure': 'Percentage of Days With no Flatulence.', 'timeFrame': '5 days', 'description': 'The percentage of days with no flatulence is calculated from the diary during the treatment period: 100\\*(number of days with no flatulence/number of days recorded in diary). Higher values indicate a better response.'}, {'measure': 'Percentage of Days With Formed/Normal Stools.', 'timeFrame': '5 days', 'description': 'The percentage of days with formed/normal stools is calculated from the diary during the treatment period: 100\\*(number of days with formed/normal stools/number of days with any stool). Higher values indicate a better response.'}, {'measure': 'Percentage of Days With no Abdominal Pain.', 'timeFrame': '5 days', 'description': 'The percentage of days with no abdominal pain is calculated from the diary during the treatment period: 100\\*(number of days with no abdominal pain / number of days recorded in diary). Higher values indicate a better response.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cystic Fibrosis', 'Pancreatic Exocrine Insufficiency'], 'conditions': ['Cystic Fibrosis', 'Pancreatic Exocrine Insufficiency']}, 'referencesModule': {'references': [{'pmid': '20171415', 'type': 'RESULT', 'citation': 'Graff GR, Maguiness K, McNamara J, Morton R, Boyd D, Beckmann K, Bennett D. Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. Clin Ther. 2010 Jan;32(1):89-103. doi: 10.1016/j.clinthera.2010.01.012.'}, {'pmid': '21681115', 'type': 'DERIVED', 'citation': 'Caras S, Boyd D, Zipfel L, Sander-Struckmeier S. Evaluation of stool collections to measure efficacy of PERT in subjects with exocrine pancreatic insufficiency. J Pediatr Gastroenterol Nutr. 2011 Dec;53(6):634-40. doi: 10.1097/MPG.0b013e3182281c38.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the effect of pancrelipase delayed release 12,000 unit capsules on fat and nitrogen absorption in subjects 7 - 11 with pancreatic exocrine insufficiency due to Cystic Fibrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed CF diagnosis by two positive chloride sweat tests or gene analysis\n* Confirmed PEI by historical Coefficient of fat Absorption \\< 70% without supplementation or current or historical fecal elastase \\< 50µg/stool (within the last 12 months)\n* Currently receiving treatment with a commercially available pancreatic enzyme product on a stable dose for more than 3 months\n* Clinically stable condition without evidence of acute respiratory disease or any other acute condition\n* Stable body weight and agrees to abstain from sexual activity\n\nExclusion Criteria:\n\n* Ileus or acute abdomen\n* History of fibrosing colonopathy, celiac disease, gastrectomy, Crohn´s disease and small bowel surgery other than minor resection due to meconium ileus without resulting in malabsorption syndrome\n* History of distal ileal obstruction syndrome within 6 months of enrollment\n* Use of an immunosuppressive drug\n* Any type of malignancy involving the digestive tract in the last 5 years\n* Known infection with HIV'}, 'identificationModule': {'nctId': 'NCT00690820', 'briefTitle': 'Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Solvay Pharmaceuticals'}, 'officialTitle': 'A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'S245.3.127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: Pancrelipase Delayed Release']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B', 'interventionNames': ['Drug: Placebo Comparator']}], 'interventions': [{'name': 'Pancrelipase Delayed Release', 'type': 'DRUG', 'description': '12,000 unit Capsules, dosed individually based on fat intake.', 'armGroupLabels': ['A']}, {'name': 'Placebo Comparator', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Site 2', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Site 5', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Site 9', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Site 6', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Site 4', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Site 8', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site 1', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Site 10', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Site 7', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Site 3', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Global Clinical Director Solvay', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Solvay Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Solvay Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Djenane Bennett', 'oldOrganization': 'Solvay Pharmaceuticals'}}}}