Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
Study NCT ID:
NCT01327703
Status:
COMPLETED
Last Update Posted:
2014-04-10
First Post:
2011-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010188', 'term': 'Exocrine Pancreatic Insufficiency'}, {'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D045602', 'term': 'Steatorrhea'}, {'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D044342', 'term': 'Malnutrition'}], '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'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}]}}, '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 vary in accordance with each agreement with the individual investigators. Sponsor will allow publication after a 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 can defer publication for a period of time to allow for Sponsor to obtain patent or other intellectual property right protection.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 30 days after last dose', 'description': 'Adverse event (AE) was any untoward medical occurrence regardless of causal relationship to study drug. Serious AE 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. Participants at risk: Panzytrat®=86 and Kreon®=85.', 'eventGroups': [{'id': 'EG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.", 'otherNumAtRisk': 86, 'otherNumAffected': 32, 'seriousNumAtRisk': 86, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.", 'otherNumAtRisk': 85, 'otherNumAffected': 20, 'seriousNumAtRisk': 85, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Gastrointestinal infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Infective pulmonary exacerbation of cystic fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Varicella', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Pseudomonas test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Vitamin A decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 85, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.1)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Coefficient of Fat Absorption (CFA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}, {'id': 'OG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}], 'classes': [{'categories': [{'measurements': [{'value': '78.27', 'spread': '1.033', 'groupId': 'OG000'}, {'value': '80.35', 'spread': '1.033', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4590', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Treatment difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.08', 'ciLowerLimit': '-7.23', 'ciUpperLimit': '4.02', 'pValueComment': 'As there was only a single pre-specified primary analysis, there was no adjustment for multiplicity.', 'groupDescription': 'Mixed model analysis method was used for comparison using log-transformed percent CFA as the response variable, fixed effect factors for treatment, period, treatment sequence and pooled site and participant within treatment sequence as a random effect.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Non-inferiority was declared if the lower bound of the 2-sided 95% confidence interval (CI) of Panzytrat® versus Kreon® exceeded -10%.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment periods', 'description': 'Percent CFA was calculated as (\\[fat intake - fat excretion\\]/fat intake)\\*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data.', 'unitOfMeasure': 'percent CFA', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol population included all randomized participants who completed both treatment periods and had all bowel movements appropriately collected with no major protocol violations/deviations or other events considered to potentially bias the study evaluations.'}, {'type': 'SECONDARY', 'title': 'Mean Daily Number of Stools', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}, {'id': 'OG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '2.43', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment 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 12 to Day 15 in first and second treatment periods) for total participants was summarized.', 'unitOfMeasure': 'stools per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Intent-to-treat (ITT) population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Stools With Normal Consistency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}, {'id': 'OG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}], 'classes': [{'categories': [{'measurements': [{'value': '0.644', 'spread': '0.3442', 'groupId': 'OG000'}, {'value': '0.635', 'spread': '0.3517', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment periods', 'description': 'Normal consistency of stool was defined as formed hard, normal or soft stool and abnormal consistency was defined as loose and unformed, liquid stool and diarrhea. Percentage of stools with normal consistency of each participant was calculated as the number of stools with normal consistency relative to the total number of stools during the collection period. Mean percentage of stool with normal consistency during the collection period (Day 12 to Day 15 in first and second treatment periods) for total participants was summarized.', 'unitOfMeasure': 'percentage of stools', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants. Here, 'N' (number of participants analyzed) specify signifies those participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Total Weight of Stools', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}, {'id': 'OG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}], 'classes': [{'categories': [{'measurements': [{'value': '521.6', 'spread': '301.95', 'groupId': 'OG000'}, {'value': '484.0', 'spread': '326.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment periods', 'description': 'Mean total weight of stools was calculated for Day 12 to Day 15 in first and second treatment periods.', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period."}, {'type': 'SECONDARY', 'title': 'Mean Weight Per Stool Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '83', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}, {'id': 'OG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}], 'classes': [{'categories': [{'measurements': [{'value': '131.7', 'spread': '79.67', 'groupId': 'OG000'}, {'value': '124.0', 'spread': '81.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment periods', 'description': 'Mean weight per stool sample was calculated for Day 12 to Day 15 in first and second treatment periods.', 'unitOfMeasure': 'gram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants. Here, 'N' (number of participants analyzed) signifies those participants who had 1 or more bowel movements over the 72-hour collection period."}, {'type': 'SECONDARY', 'title': 'Relative Frequency of Days With Abdominal Symptoms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}, {'id': 'OG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}], 'classes': [{'title': 'Abdominal pain (n=86, 85)', 'categories': [{'measurements': [{'value': '0.227', 'spread': '0.2500', 'groupId': 'OG000'}, {'value': '0.216', 'spread': '0.2251', 'groupId': 'OG001'}]}]}, {'title': 'Mild abdominal pain (n=58, 57)', 'categories': [{'measurements': [{'value': '0.302', 'spread': '0.2440', 'groupId': 'OG000'}, {'value': '0.308', 'spread': '0.2199', 'groupId': 'OG001'}]}]}, {'title': 'Moderate abdominal pain (n=37, 39)', 'categories': [{'measurements': [{'value': '0.434', 'spread': '0.2496', 'groupId': 'OG000'}, {'value': '0.374', 'spread': '0.2269', 'groupId': 'OG001'}]}]}, {'title': 'Severe abdominal pain (n=14, 12)', 'categories': [{'measurements': [{'value': '0.429', 'spread': '0.2646', 'groupId': 'OG000'}, {'value': '0.400', 'spread': '0.2741', 'groupId': 'OG001'}]}]}, {'title': 'Flatulence (n=86, 85)', 'categories': [{'measurements': [{'value': '0.365', 'spread': '0.3215', 'groupId': 'OG000'}, {'value': '0.329', 'spread': '0.3290', 'groupId': 'OG001'}]}]}, {'title': 'Mild flatulence (n=67, 61)', 'categories': [{'measurements': [{'value': '0.467', 'spread': '0.2912', 'groupId': 'OG000'}, {'value': '0.459', 'spread': '0.3018', 'groupId': 'OG001'}]}]}, {'title': 'Moderate flatulence (n=35, 40)', 'categories': [{'measurements': [{'value': '0.351', 'spread': '0.2649', 'groupId': 'OG000'}, {'value': '0.577', 'spread': '0.2806', 'groupId': 'OG001'}]}]}, {'title': 'Severe flatulence (n=20, 13)', 'categories': [{'measurements': [{'value': '0.616', 'spread': '0.2959', 'groupId': 'OG000'}, {'value': '0.554', 'spread': '0.1968', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 up to Day 15 in first and second treatment periods', 'description': 'Abdominal symptoms included abdominal pain and flatulence. 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). For each type of abdominal symptom, the relative frequency of days with the symptom for each participant in a treatment period was calculated as the number of days in which the symptom was reported divided by the total number of days in which the abdominal symptom case report form (CRF) was completed. Mean relative frequency of days with abdominal symptoms was calculated during each treatment period (Day 1 to Day 15).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies the number of participants with at least one report of the symptom at that severity level during a treatment period."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Abdominal Distension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}, {'id': 'OG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}], 'classes': [{'categories': [{'measurements': [{'value': '12.8', 'groupId': 'OG000'}, {'value': '11.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 up to Day 15 in first and second treatment periods', 'description': "Abdominal distension is a sense of increased abdominal pressure by the participant that involves an actual measurable change in the circumference of a participant's abdomen on physical examination. Percentage of participants with abdominal distension was calculated for each treatment period (Day 1 to Day 15).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all randomized participants. Here, 'N' specifies number of participants who had abdominal distension assessment at screening and end of specified treatment."}, {'type': 'SECONDARY', 'title': 'Percent Coefficient of Fat Absorption (CFA) Based on Concomitant Use of Proton Pump Inhibitors (PPIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}, {'id': 'OG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}], 'classes': [{'title': 'PPIs used (n=7, 7)', 'categories': [{'measurements': [{'value': '79.66', 'spread': '1.071', 'groupId': 'OG000'}, {'value': '94.29', 'spread': '1.071', 'groupId': 'OG001'}]}]}, {'title': 'PPIs not used (n=31, 31)', 'categories': [{'measurements': [{'value': '80.89', 'spread': '1.037', 'groupId': 'OG000'}, {'value': '79.24', 'spread': '1.037', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment periods', 'description': 'Percent CFA was calculated as (\\[fat intake - fat excretion\\]/fat intake)\\*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data. Percent CFA was calculated separately for participants who used and did not use acid suppressing therapy (PPIs) during the study.', 'unitOfMeasure': 'percent CFA', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Per protocol population. Here, 'n' specifies number of participants who were evaluable for specific categories for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}, {'id': 'OG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 30 days after last dose', 'description': 'An AE was defined as any untoward medical occurrence regardless of its causal relationship to study drug. A TEAE was defined as any event not present prior to exposure to study drug or any event already present that worsens in either intensity or frequency following exposure to test drug. A SAE was defined as any event that results in death, is immediately life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect or is assessed as medically important.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all randomized participants who received at least 1 dose of study medication. Here, 'N' (number of participants analyzed) specifies number of participants who were evaluable for this measure."}, {'type': 'SECONDARY', 'title': 'Nutritional Status as Assessed by Body Weight', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}, {'id': 'OG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '40.82', 'spread': '16.001', 'groupId': 'OG000'}, {'value': '41.43', 'spread': '15.861', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment', 'categories': [{'measurements': [{'value': '41.22', 'spread': '15.999', 'groupId': 'OG000'}, {'value': '41.88', 'spread': '15.886', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation', 'description': 'Mean body weight was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Nutritional Status as Assessed by Body Mass Index (BMI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}, {'id': 'OG001', 'title': 'Kreon®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '17.84', 'spread': '3.296', 'groupId': 'OG000'}, {'value': '17.90', 'spread': '3.264', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment', 'categories': [{'measurements': [{'value': '17.94', 'spread': '3.244', 'groupId': 'OG000'}, {'value': '18.01', 'spread': '3.240', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation', 'description': 'Nutritional status of participants was assessed by determining their BMI. BMI was calculated by dividing body weight (kg) by square of height in meter (m). Mean BMI was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Nutritional Status as Assessed by Electrolytes Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat® First, Then Kreon®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day."}, {'id': 'OG001', 'title': 'Kreon®, First, Then Panzytrat®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day."}], 'classes': [{'title': 'Sodium: Baseline (n=42, 43)', 'categories': [{'measurements': [{'value': '138.41', 'spread': '3.026', 'groupId': 'OG000'}, {'value': '138.54', 'spread': '3.356', 'groupId': 'OG001'}]}]}, {'title': 'Sodium: End of treatment (n=42, 43)', 'categories': [{'measurements': [{'value': '139.11', 'spread': '2.350', 'groupId': 'OG000'}, {'value': '139.07', 'spread': '2.466', 'groupId': 'OG001'}]}]}, {'title': 'Potassium: Baseline (n=42, 42)', 'categories': [{'measurements': [{'value': '4.441', 'spread': '0.4799', 'groupId': 'OG000'}, {'value': '4.371', 'spread': '0.3721', 'groupId': 'OG001'}]}]}, {'title': 'Potassium: End of treatment (n=42, 42)', 'categories': [{'measurements': [{'value': '4.322', 'spread': '0.4113', 'groupId': 'OG000'}, {'value': '4.344', 'spread': '0.3506', 'groupId': 'OG001'}]}]}, {'title': 'Chloride: Baseline (n=38, 40)', 'categories': [{'measurements': [{'value': '102.08', 'spread': '3.436', 'groupId': 'OG000'}, {'value': '101.40', 'spread': '3.193', 'groupId': 'OG001'}]}]}, {'title': 'Chloride: End of treatment (n=38, 40)', 'categories': [{'measurements': [{'value': '102.13', 'spread': '2.796', 'groupId': 'OG000'}, {'value': '102.18', 'spread': '2.541', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation', 'description': 'Nutritional status of participants was assessed by determining their electrolytes (sodium, potassium and chloride) level. Mean electrolytes level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).', 'unitOfMeasure': 'millimole/L (mmol/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Nutritional Status as Assessed by Albumin, Serum Transferrin and Hemoglobin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat® First, Then Kreon®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day."}, {'id': 'OG001', 'title': 'Kreon® First, Then Panzytrat®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day."}], 'classes': [{'title': 'Albumin: Baseline (n=41, 42)', 'categories': [{'measurements': [{'value': '40.553', 'spread': '11.3568', 'groupId': 'OG000'}, {'value': '37.995', 'spread': '14.8405', 'groupId': 'OG001'}]}]}, {'title': 'Albumin: End of treatment (n=41, 42)', 'categories': [{'measurements': [{'value': '40.785', 'spread': '11.1893', 'groupId': 'OG000'}, {'value': '37.991', 'spread': '14.9636', 'groupId': 'OG001'}]}]}, {'title': 'Serum transferrin: Baseline (n=40, 41)', 'categories': [{'measurements': [{'value': '2.877', 'spread': '0.9769', 'groupId': 'OG000'}, {'value': '2.618', 'spread': '1.1857', 'groupId': 'OG001'}]}]}, {'title': 'Serum transferrin: End of treatment (n=40, 41)', 'categories': [{'measurements': [{'value': '2.916', 'spread': '0.9416', 'groupId': 'OG000'}, {'value': '2.626', 'spread': '1.1618', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin: Baseline (n=42, 42)', 'categories': [{'measurements': [{'value': '137.337', 'spread': '11.7570', 'groupId': 'OG000'}, {'value': '141.118', 'spread': '11.4577', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin: End of treatment (n=42, 42)', 'categories': [{'measurements': [{'value': '137.935', 'spread': '11.4543', 'groupId': 'OG000'}, {'value': '141.263', 'spread': '11.4412', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation', 'description': 'Nutritional status of participants was assessed by determining their albumin, serum transferrin and hemoglobin level. Mean albumin, serum transferrin and hemoglobin level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).', 'unitOfMeasure': 'gram/L (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure and 'n' specifies number of participants who were evaluable for specific categories at each time point for each arm group, respectively."}, {'type': 'SECONDARY', 'title': 'Nutritional Status as Assessed by Hematocrit Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panzytrat® First, Then Kreon®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day."}, {'id': 'OG001', 'title': 'Kreon® First, Then Panzytrat®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '0.408', 'spread': '0.0324', 'groupId': 'OG000'}, {'value': '0.417', 'spread': '0.0333', 'groupId': 'OG001'}]}]}, {'title': 'End of treatment', 'categories': [{'measurements': [{'value': '0.409', 'spread': '0.0311', 'groupId': 'OG000'}, {'value': '0.416', 'spread': '0.0328', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation', 'description': 'Nutritional status of participants was assessed by determining their hematocrit level. Mean hematocrit level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).', 'unitOfMeasure': 'proportion of hematocrit', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety population included all randomized participants who received at least 1 dose of study drug. Here, 'N' specifies number of participants who were evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Panzytrat® First, Then Kreon®', 'description': "Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day."}, {'id': 'FG001', 'title': 'Kreon® First, Then Panzytrat®', 'description': "Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day."}], 'periods': [{'title': 'First Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Two participants discontinued between first and second treatment periods due to adverse event.', 'groupId': 'FG000', 'numSubjects': '40'}, {'comment': 'One participant discontinued between first and second treatment periods due to adverse event.', 'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population', 'description': 'Includes randomized participants who received Panzytrat® 25,000 first and Kreon® 25,000 first.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'spread': '6.14', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Nutritional status as assessed by Vitamin A and E level', 'classes': [{'title': 'Vitamin A (n=87)', 'categories': [{'measurements': [{'value': '1.403', 'spread': '0.5329', 'groupId': 'BG000'}]}]}, {'title': 'Vitamin E (Alpha-Tocopherol) (n=87)', 'categories': [{'measurements': [{'value': '18.554', 'spread': '8.9713', 'groupId': 'BG000'}]}]}, {'title': 'Vitamin E (Beta-Gamma-Tocopherol) (n=83)', 'categories': [{'measurements': [{'value': '1.231', 'spread': '2.0781', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "Nutritional status was assessed by determining Vitamin A and E (Alpha-Tocopherol and Beta-Gamma-Tocopherol) level. Here, 'n' signifies number of participants who were evaluable for the specific categories of this baseline characteristic.", 'unitOfMeasure': 'micromole/liter (mcmol/L)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Nutritional status as assessed by Vitamin D level', 'classes': [{'categories': [{'measurements': [{'value': '55.4', 'spread': '33.24', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Nutritional status was assessed by determining Vitamin D level. Number of participants who were evaluable for Vitamin D level was 86.', 'unitOfMeasure': 'nanomole/L (nmol/L)', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-treat (ITT) population included all randomized participants.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-05', 'studyFirstSubmitDate': '2011-03-28', 'resultsFirstSubmitDate': '2014-03-05', 'studyFirstSubmitQcDate': '2011-03-31', 'lastUpdatePostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-05', 'studyFirstPostDateStruct': {'date': '2011-04-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Coefficient of Fat Absorption (CFA)', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment periods', 'description': 'Percent CFA was calculated as (\\[fat intake - fat excretion\\]/fat intake)\\*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data.'}], 'secondaryOutcomes': [{'measure': 'Mean Daily Number of Stools', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment 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 12 to Day 15 in first and second treatment periods) for total participants was summarized.'}, {'measure': 'Percentage of Stools With Normal Consistency', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment periods', 'description': 'Normal consistency of stool was defined as formed hard, normal or soft stool and abnormal consistency was defined as loose and unformed, liquid stool and diarrhea. Percentage of stools with normal consistency of each participant was calculated as the number of stools with normal consistency relative to the total number of stools during the collection period. Mean percentage of stool with normal consistency during the collection period (Day 12 to Day 15 in first and second treatment periods) for total participants was summarized.'}, {'measure': 'Total Weight of Stools', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment periods', 'description': 'Mean total weight of stools was calculated for Day 12 to Day 15 in first and second treatment periods.'}, {'measure': 'Mean Weight Per Stool Sample', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment periods', 'description': 'Mean weight per stool sample was calculated for Day 12 to Day 15 in first and second treatment periods.'}, {'measure': 'Relative Frequency of Days With Abdominal Symptoms', 'timeFrame': 'Day 1 up to Day 15 in first and second treatment periods', 'description': 'Abdominal symptoms included abdominal pain and flatulence. 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). For each type of abdominal symptom, the relative frequency of days with the symptom for each participant in a treatment period was calculated as the number of days in which the symptom was reported divided by the total number of days in which the abdominal symptom case report form (CRF) was completed. Mean relative frequency of days with abdominal symptoms was calculated during each treatment period (Day 1 to Day 15).'}, {'measure': 'Percentage of Participants With Abdominal Distension', 'timeFrame': 'Day 1 up to Day 15 in first and second treatment periods', 'description': "Abdominal distension is a sense of increased abdominal pressure by the participant that involves an actual measurable change in the circumference of a participant's abdomen on physical examination. Percentage of participants with abdominal distension was calculated for each treatment period (Day 1 to Day 15)."}, {'measure': 'Percent Coefficient of Fat Absorption (CFA) Based on Concomitant Use of Proton Pump Inhibitors (PPIs)', 'timeFrame': 'Day 12 up to Day 15 in first and second treatment periods', 'description': 'Percent CFA was calculated as (\\[fat intake - fat excretion\\]/fat intake)\\*100, determined in the stools which were collected over a 3-day period (Day 12 to morning of Day 15) during each treatment period. Least squares mean percent (%) CFA was calculated for Day 12 to Day 15 in first and second treatment periods. Percent CFA was based on log transformed data. Percent CFA was calculated separately for participants who used and did not use acid suppressing therapy (PPIs) during the study.'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs)', 'timeFrame': 'Baseline up to 30 days after last dose', 'description': 'An AE was defined as any untoward medical occurrence regardless of its causal relationship to study drug. A TEAE was defined as any event not present prior to exposure to study drug or any event already present that worsens in either intensity or frequency following exposure to test drug. A SAE was defined as any event that results in death, is immediately life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect or is assessed as medically important.'}, {'measure': 'Nutritional Status as Assessed by Body Weight', 'timeFrame': 'Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation', 'description': 'Mean body weight was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).'}, {'measure': 'Nutritional Status as Assessed by Body Mass Index (BMI)', 'timeFrame': 'Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation', 'description': 'Nutritional status of participants was assessed by determining their BMI. BMI was calculated by dividing body weight (kg) by square of height in meter (m). Mean BMI was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).'}, {'measure': 'Nutritional Status as Assessed by Electrolytes Level', 'timeFrame': 'Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation', 'description': 'Nutritional status of participants was assessed by determining their electrolytes (sodium, potassium and chloride) level. Mean electrolytes level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).'}, {'measure': 'Nutritional Status as Assessed by Albumin, Serum Transferrin and Hemoglobin Level', 'timeFrame': 'Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation', 'description': 'Nutritional status of participants was assessed by determining their albumin, serum transferrin and hemoglobin level. Mean albumin, serum transferrin and hemoglobin level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).'}, {'measure': 'Nutritional Status as Assessed by Hematocrit Level', 'timeFrame': 'Baseline, end of treatment (within 3 days after Day 15 of first and second treatment periods) or early discontinuation', 'description': 'Nutritional status of participants was assessed by determining their hematocrit level. Mean hematocrit level was calculated at end of treatment (within 3 days after Day 15 of first and second treatment periods).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Exocrine Pancreatic Insufficiency', 'Cystic Fibrosis', 'Steatorrhea', 'Malabsorption', 'Malnutrition'], 'conditions': ['Exocrine Pancreatic Insufficiency', 'Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).', 'detailedDescription': 'This is an open-label, Phase IV, multicenter, randomized, two-period cross-over study to compare the efficacy and safety of Panzytrat® 25,000 to Kreon® 25,000 in participants aged 7 years and older suffering from CF and EPI. The study consists of a qualification phase (5 to 15 days); two treatment periods of 14 days each (plus a 3-day window if needed) and a 3-day stool collection will be performed from Days 12 to 15.\n\nA safety follow-up phone call will be arranged 7-10 days after completion of the treatment phase or after an early discontinuation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participant or his/her legal representative signed informed consent form (ICF) prior to starting any study procedures\n* Participant with clinical diagnosis of CF based on one or more typical clinical features of CF phenotype, in addition to one of the following: a genotype that documents the presence of 2 CF-causing mutation, or a sweat chloride test greater than or equal to 60 millimole per liter (mmol/L) by quantitative pilocarpine iontophoresis on two separate occasions\n* Participant with severe EPI confirmed by enzyme-linked immunosorbent assay (ELISA) measurement of fecal elastase-1 (FE-1)\n* Male or female participant aged 7 years or older\n* Participant currently receiving and has received a stable dose of lipase with either Panzytrat® 25,000 or Kreon® 25,000 for at least 30 days prior to ICF signature\n* Participant generally in good health, except for the underlying symptoms associated with CF and EPI, and is clinically stable (no change in the last 30 days of physical examination) as evidenced by medical and medication histories, physical examination including vital signs during screening and laboratory tests\n* Participant able to maintain a CF standardized diet with a lipid content customized to his/her needs during the study according to the qualification phase diary\n* Women of childbearing potential must have a negative pregnancy test at study entry and must use a medically acceptable contraceptive method for the duration of the study\n\nExclusion Criteria:\n\n* Participant with known contraindication, sensitivity or hypersensitivity to Panzytrat® 25,000 or Kreon® 25,000, or to any porcine protein\n* Participant who recently received treatment of an emergent acute infection with oral or intravenous (IV) antibiotics that was not stopped at least 14 days prior to randomization\n* Participant with chronic use of narcotics that were not stopped at least 7 days prior to the qualification visit\n* Participant using of any prohibited medications or products listed in the prohibited medication section of the protocol\n* Participant with acute pancreatitis or exacerbation of chronic pancreatic disease\n* Participant with history of significant bowel resection that could impair fat absorption\n* Participant with any condition known to increase fecal fat loss including but not limited to: celiac disease, Crohn's disease, tropical sprue, bacterial bowel infection, liver disease, lactose intolerance, pseudomembranous colitis, biliary and pancreatic cancer, radiation enteritis, Whipple's disease, Whipple's procedure, etc\n* Participant with any significant gastrointestinal dysmotility disorders\n* Participant with chronic abdominal pain or severe abdominal pain at study entry\n* Participant using enteral tube feeding over day and night\n* Participant with history or presence of clinically significant portal hypertension\n* Participant with history or presence of complete distal intestinal obstruction syndrome (DIOS) in the past 6 months, or 2 or more episodes of DIOS in the past year\n* Participant with poorly controlled diabetes as per the investigator's opinion\n* Female participants who are pregnant or breastfeeding\n* Participant with any condition or history of any illness, or pre-study laboratory abnormality which, in the opinion of the investigator or sponsor, might put the participant at risk, prevent the participant from completing the study, or otherwise affect the outcome of the study\n* Participant using any investigational drug within 30 days prior to the date of signature of the ICF"}, 'identificationModule': {'nctId': 'NCT01327703', 'briefTitle': 'Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency', 'organization': {'class': 'INDUSTRY', 'fullName': 'Forest Laboratories'}, 'officialTitle': 'An Open-label, Multicenter, Randomized, Cross-over Study to Compare the Safety and Efficacy of PANZYTRAT® 25,000 to KREON® 25,000 in the Control of Steatorrhea in Subjects Aged 7 Years and Older With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI)', 'orgStudyIdInfo': {'id': 'MA-PA25CF10-01'}, 'secondaryIdInfos': [{'id': '2010-019267-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panzytrat® 25,000', 'interventionNames': ['Drug: Panzytrat® 25,000']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Kreon® 25,000', 'interventionNames': ['Drug: Kreon® 25,000']}], 'interventions': [{'name': 'Panzytrat® 25,000', 'type': 'DRUG', 'description': "Panzytrat® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day in either first treatment period or second treatment period.", 'armGroupLabels': ['Panzytrat® 25,000']}, {'name': 'Kreon® 25,000', 'type': 'DRUG', 'description': "Kreon® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 Ph.Eur. units lipase/kg body weight/day in either first treatment period or second treatment period.", 'armGroupLabels': ['Kreon® 25,000']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bochum', 'country': 'Germany', 'facility': 'Klinikum-Bochum', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'city': 'Dresden', 'country': 'Germany', 'facility': 'Universitätsklinikum Carl Gustav Carus', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}, {'city': 'Erlangen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}, {'city': 'Jena', 'country': 'Germany', 'facility': 'Jena University Hospital, Universitaetsklinikum Jena', 'geoPoint': {'lat': 50.92878, 'lon': 11.5899}}, {'city': 'München', 'country': 'Germany', 'facility': 'Klinikum der Universitat Munchen Medizinische Klinik-Innenstadt', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'city': 'Tübingen', 'country': 'Germany', 'facility': "University Children's Clinic Tubingen", 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Gdansk', 'country': 'Poland', 'facility': 'Specjalistyczny Zespół Opieki Zdrowotnej nad Matką i Dzieckiem Poradnia Leczenia Mukowiscydozy', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'city': 'Krakow', 'country': 'Poland', 'facility': 'Wojewodzki Specjalistityczny Szpital Dziect Im Sw Ludwika', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Lublin', 'country': 'Poland', 'facility': 'Dziecięcy Szpital Kliniczny im. Prof. Antoniego Gębali', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'city': 'Poznan', 'country': 'Poland', 'facility': 'Szpital Kliniczny im Karola Jonschera', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'city': 'Rabka-Zdrój', 'country': 'Poland', 'facility': 'NZOZ Sanatorium Cassia Villa Medica', 'geoPoint': {'lat': 49.60889, 'lon': 19.96654}}, {'city': 'Rzeszów', 'country': 'Poland', 'facility': 'NZOZ Podkarpacki Osrodek Pulmonologii i Alergologii', 'geoPoint': {'lat': 50.04132, 'lon': 21.99901}}, {'city': 'Warsaw', 'country': 'Poland', 'facility': "Children's Health Memorial Institute", 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Aptalis Medical Information', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Forest Laboratories'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Forest Laboratories', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}