Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 1:32 AM
Study NCT ID:
NCT01565694
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2012-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada', 'France', 'Germany', 'India', 'Netherlands', 'Russia', 'United Kingdom']}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069464', 'term': 'Solifenacin Succinate'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D044005', 'term': 'Tetrahydroisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'astellas.resultsdisclosure@astellas.com', 'phone': '310715455050', 'title': 'Clinical Trial Disclosure', 'organization': 'Astellas Pharma Europe B.V.'}, 'certainAgreement': {'otherDetails': 'The investigator agrees to submit all manuscripts or abstracts to the Sponsor at least 1 month prior to the submission of any such information to an editorial board or scientific review committee. This allows the Sponsor to protect proprietary information and to provide comments based on information from other studies that may not yet be available to the investigator.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From the first dose of study drug to the last dose of study drug (up to week 52).', 'eventGroups': [{'id': 'EG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 42, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Escherichia urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 17, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Electrocardiogram QT prolonged', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Bladder pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Decubitus ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'seriousEvents': [{'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Megacolon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Dengue fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Urinary tract infection bacterial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Tethered cord syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Spinal cord operation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '57.2', 'spread': '107.7', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.3', 'spread': '107.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'spread': '105.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was obtained from a 2-sided one sample t-test, testing the null hypothesis that Change from Baseline=0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 9 or Week 12', 'description': 'During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. Based on study requirements, the last possible titration step was Week 9 for participants enrolled under versions 1.0 and 1.1 and Week 12 under later versions.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. The number of participant analyzed represents participants with a non-missing change from baseline to last possible titration step.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bladder Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '28.6', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.8', 'spread': '27.8', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}, {'pValue': '0.026', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Bladder compliance gives an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder.', 'unitOfMeasure': 'mL/cmH2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'categories': [{'measurements': [{'value': '23.10', 'groupId': 'OG000', 'lowerLimit': '-117.2', 'upperLimit': '114.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'From a Wilcoxon Signed Rank testing the null hypothesis is that the Median at Week 24 is equal to Baseline Median.'}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in the bladder volume was calculated using urodyanamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. If no detrusor contraction of at least 15 cmH2O occurs, the bladder volume was imputed with MCC.', 'unitOfMeasure': 'Percentage of EBC', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '61.8', 'spread': '80.6', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '71.9', 'spread': '88.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 in bladder volume at 30 cmH20.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0'}, {'pValue': '0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF in bladder volume at 30 cmH20.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Bladder volumes at 30 cm H2O detrusor pressure was calculated using the urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the participants experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized. Only participants who reached 30 cmH20 detrusor pressure were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.0', 'spread': '44.3', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '54.4', 'spread': '52.9', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to week 24 in bladder volume at 40 cmH20.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0'}, {'pValue': '0.004', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to week 24 LOCF in bladder volume at 40 cmH20.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Bladder volumes at 40 cm H2O detrusor pressure were calculated using urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized. Only participants who reached 40 cmH20 detrusor pressure were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '5.1', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '6.0', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0'}, {'pValue': '0.028', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline in number of overactive detrusor contractions until end of bladder filling was measured by urodynamic testing. If leakage occurred, the "Detrusor pressure at leakage" was recorded otherwise the volume of fluid instilled into the bladder was recorded.', 'unitOfMeasure': 'Detrusor Contractions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Detrusor Pressure at the End of Bladder Filling', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-9.2', 'spread': '33.6', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-8.2', 'spread': '32.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.068', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}, {'pValue': '0.075', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The bladder was filled until voiding/leakage began or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. Pressure was recorded for an extra 5 minutes after leakage began or the end of bladder-filling, whichever is sooner.', 'unitOfMeasure': 'cmH2O', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average Catheterized Volume Per Catheterization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '46.23', 'spread': '48.32', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.86', 'spread': '50.98', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days are concurrent.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Maximum Catheterized Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.45', 'spread': '88.07', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '69.63', 'spread': '88.84', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Average First Morning Catheterized Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '43.24', 'spread': '72.78', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '44.21', 'spread': '73.40', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.60', 'spread': '2.04', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.62', 'spread': '2.04', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The mean of the number of incontinence episodes per 24h was calculated as the mean over the valid diary days in the 7-day diary.', 'unitOfMeasure': 'Incontinence Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.06', 'spread': '2.83', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.19', 'spread': '2.86', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}, {'pValue': '0.004', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The number of incontinence-free days was calculated from the 7-day micturition diary.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.60', 'spread': '3.08', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.64', 'spread': '3.06', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'The number of incontinence-free nights was calculated from the 7-day micturition diary.', 'unitOfMeasure': 'Nights', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'Change from Baseline Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '8.3', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline Week 24 (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '8.3', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.568', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}, {'pValue': '0.573', 'groupIds': ['OG000'], 'groupDescription': 'Analysis of change from baseline to Week 24 LOCF.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'P-Value was calculated from a 2-sided one sample t-test, testing the null hypothesis that change from baseline = 0.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 24', 'description': 'Pediatric Incontinence Questionnaire (PinQ) is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicated more impact on the quality of life.', 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug. Last observation carried forward (LOCF) was utilized.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG000'}]}]}, {'title': 'Drug related TEAE', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serious TEAEs', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Drug related Serious TEAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'TEAEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Drug related TEAEs Leading to Discontinuation', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to End of Study Visit (Week 52)', 'description': 'A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the first dose of study medication on Day 1. All adverse events collected within 7 days after taking the last dose of study drug were counted as a TEAE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during dose-titration period. After completing dose titration period, participants entered fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).'}], 'periods': [{'title': 'Dose-Titration Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}]}, {'title': 'Fixed-Dose Assessment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'The study population consisted of male and female participants with neurogenic detrusor overactivity (NDO) aged 5 years to \\< 18 years old.', 'preAssignmentDetails': "After screening and a 14-day washout period, participants were treated with sequential doses of solifenacin oral suspension for 12 weeks (titration period) to determine each participant's optimal dose, after which a fixed dose of solifenacin oral suspension was given for at least 40 weeks (fixed dose assessment period)."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Solifenacin Succinate', 'description': 'Participants aged 5 years to \\< 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks to identify optimal dose during the dose-titration period. After the dose titration period participants entered the fixed-dose period and received a fixed dose of solifenacin once a day orally for 40 weeks or until the end of study visit (Week 52).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '10.8', 'spread': '3.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '65', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Black/African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}, {'title': 'American Indian/Alaskan Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '38.1', 'spread': '15.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilogram (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '138', 'spread': '16.3', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters (cm)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'spread': '4.69', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '(kg/m^2)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Neurogenic Detrusor Overactivity (NDO) Disease', 'classes': [{'categories': [{'measurements': [{'value': '8.24', 'groupId': 'BG000', 'lowerLimit': '0.4', 'upperLimit': '16.2'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}], 'populationDescription': 'The full analysis set (FAS) consisted of all participants who had a baseline and 1 post baseline measurement for the primary endpoint (MCC) and have received at least 1 dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'dispFirstSubmitDate': '2017-04-18', 'completionDateStruct': {'date': '2016-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-20', 'studyFirstSubmitDate': '2012-03-27', 'dispFirstSubmitQcDate': '2017-04-18', 'resultsFirstSubmitDate': '2019-04-10', 'studyFirstSubmitQcDate': '2012-03-27', 'dispFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2024-11-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-04-10', 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)', 'timeFrame': 'Baseline and Week 24', 'description': 'During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity', 'timeFrame': 'Baseline, Week 9 or Week 12', 'description': 'During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. Based on study requirements, the last possible titration step was Week 9 for participants enrolled under versions 1.0 and 1.1 and Week 12 under later versions.'}, {'measure': 'Change From Baseline in Bladder Compliance', 'timeFrame': 'Baseline and Week 24', 'description': 'Bladder compliance gives an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder.'}, {'measure': 'Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)', 'timeFrame': 'Baseline and Week 24', 'description': 'Change from baseline in the bladder volume was calculated using urodyanamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. If no detrusor contraction of at least 15 cmH2O occurs, the bladder volume was imputed with MCC.'}, {'measure': 'Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure', 'timeFrame': 'Baseline and Week 24', 'description': 'Bladder volumes at 30 cm H2O detrusor pressure was calculated using the urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the participants experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.'}, {'measure': 'Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure', 'timeFrame': 'Baseline and Week 24', 'description': 'Bladder volumes at 40 cm H2O detrusor pressure were calculated using urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.'}, {'measure': 'Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling', 'timeFrame': 'Baseline to Week 24', 'description': 'Change from baseline in number of overactive detrusor contractions until end of bladder filling was measured by urodynamic testing. If leakage occurred, the "Detrusor pressure at leakage" was recorded otherwise the volume of fluid instilled into the bladder was recorded.'}, {'measure': 'Change From Baseline in Detrusor Pressure at the End of Bladder Filling', 'timeFrame': 'Baseline to Week 24', 'description': 'The bladder was filled until voiding/leakage began or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. Pressure was recorded for an extra 5 minutes after leakage began or the end of bladder-filling, whichever is sooner.'}, {'measure': 'Change From Baseline in Average Catheterized Volume Per Catheterization', 'timeFrame': 'Baseline to Week 24', 'description': 'The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days are concurrent.'}, {'measure': 'Change From Baseline in Maximum Catheterized Volume', 'timeFrame': 'Baseline to Week 24', 'description': 'The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.'}, {'measure': 'Change From Baseline in Average First Morning Catheterized Volume', 'timeFrame': 'Baseline to Week 24', 'description': 'The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.'}, {'measure': 'Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours', 'timeFrame': 'Baseline to Week 24', 'description': 'The mean of the number of incontinence episodes per 24h was calculated as the mean over the valid diary days in the 7-day diary.'}, {'measure': 'Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days', 'timeFrame': 'Baseline to Week 24', 'description': 'The number of incontinence-free days was calculated from the 7-day micturition diary.'}, {'measure': 'Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days', 'timeFrame': 'Baseline to Week 24', 'description': 'The number of incontinence-free nights was calculated from the 7-day micturition diary.'}, {'measure': 'Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)', 'timeFrame': 'Baseline to Week 24', 'description': 'Pediatric Incontinence Questionnaire (PinQ) is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicated more impact on the quality of life.'}, {'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'Baseline to End of Study Visit (Week 52)', 'description': 'A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the first dose of study medication on Day 1. All adverse events collected within 7 days after taking the last dose of study drug were counted as a TEAE.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cognitive Function', 'Phase 3', 'Neurogenic Detrusor Overactivity', 'Pharmacokinetics', 'Ocular Accommodation', 'Urodynamics'], 'conditions': ['Neurogenic Detrusor Overactivity']}, 'referencesModule': {'references': [{'pmid': '33231929', 'type': 'DERIVED', 'citation': 'Tannenbaum S, den Adel M, Krauwinkel W, Meijer J, Hollestein-Havelaar A, Verheggen F, Newgreen D. Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity. Pharmacol Res Perspect. 2020 Dec;8(6):e00684. doi: 10.1002/prp2.684.'}, {'pmid': '32007426', 'type': 'DERIVED', 'citation': 'Franco I, Hoebeke P, Baka-Ostrowska M, Bolong D, Davies LN, Dahler E, Snijder R, Stroosma O, Verheggen F, Newgreen D, Bosman B, Vande Walle J. Long-term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open-label studies. J Pediatr Urol. 2020 Apr;16(2):180.e1-180.e8. doi: 10.1016/j.jpurol.2019.12.012. Epub 2019 Dec 27.'}], 'seeAlsoLinks': [{'url': 'https://astellasclinicalstudyresults.com/study.aspx?ID=248', 'label': 'Link to results on the Astellas Clinical Study Results website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.', 'detailedDescription': 'The NDO often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal during filling. These patients often have an inability to void, so that catheterization is required to empty the bladder.\n\nThe medicine being tested in this study is called solifenacin succinate. Solifenacin tablets are given to adults for the treatment of overactive bladder. A new liquid suspension has been developed to treat children and adolescents in this and other studies.\n\nThe efficacy and safety of the solifenacin suspension was investigated. The take-up and length of time that the solifenacin suspension stays in the body was also investigated during this study. Effectiveness was measured by urodynamics (the filling and emptying of the bladder) and the urine volumes during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days.\n\nSafety assessments included analysis of the blood and urine, review of the electrocardiogram (ECG), ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosis of NDO, confirmed by urodynamics\n* Practicing clean intermittent catheterization (CIC)\n* Currently on treatment with an antimuscarinic drug\n\nExclusion Criteria:\n\n* Known genitourinary condition (other than NDO) that may cause incontinence\n* Bladder augmentation surgery\n* Current Faecal impaction\n* Electro-stimulation therapy within 2 weeks prior to screening and at any time during the study\n* Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention\n* Reflux grade 3 or 4\n* Current urinary tract infection (UTI)\n* Subject has severe renal impairment (glomerular filtration rate \\< 30 ml/min)\n* Subject has severe hepatic impairment (Child-Pugh score \\> 9).\n* Subject has received intra-vesical botulinum toxin within 9 months prior to screening'}, 'identificationModule': {'nctId': 'NCT01565694', 'briefTitle': 'A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)', 'orgStudyIdInfo': {'id': '905-CL-047'}, 'secondaryIdInfos': [{'id': '2011-000330-11', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Solifenacin succinate', 'description': 'Participants aged 5 years to \\< 18 years received solifenacin orally once a day, with sequential titrated doses for 12 weeks to identify the optimal dose during the dose-titration period. The initial dose was pediatric equivalent dose (PED) 5 mg.\n\nAfter completing the dose titration period participants entered the fixed-dose period during which solifenacin was taken orally once a day for 40 weeks or until the end of study visit (Week 52).', 'interventionNames': ['Drug: Solifenacin succinate']}], 'interventions': [{'name': 'Solifenacin succinate', 'type': 'DRUG', 'otherNames': ['YM905'], 'description': 'Oral suspension administered once a day via syringe.', 'armGroupLabels': ['Solifenacin succinate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10591', 'city': 'Tarrytown', 'state': 'New York', 'country': 'United States', 'facility': 'Site US1008', 'geoPoint': {'lat': 41.07621, 'lon': -73.85875}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Site US1010', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Site BE3201', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '15090-000', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Site BR5505', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'zip': '13060-803', 'city': 'Campinas', 'country': 'Brazil', 'facility': 'Site BR5507', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '13083-887', 'city': 'Campinas', 'country': 'Brazil', 'facility': 'Site BR5504', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}, {'zip': '80240-060', 'city': 'Curitiba', 'country': 'Brazil', 'facility': 'Site BR5506', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'country': 'Brazil', 'facility': 'Site BR5503', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Site DK4501', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '3526', 'city': 'Miskolc', 'country': 'Hungary', 'facility': 'Site HU3602', 'geoPoint': {'lat': 48.10327, 'lon': 20.77806}}, {'zip': '37000', 'city': 'León', 'country': 'Mexico', 'facility': 'Site MX5203', 'geoPoint': {'lat': 25.60187, 'lon': -103.47698}}, {'zip': 'C.P. 06700', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'Site MX5205', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '1015', 'city': 'Manila', 'country': 'Philippines', 'facility': 'Site PH6301', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1101', 'city': 'Quezon City', 'country': 'Philippines', 'facility': 'Site PH6302', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '80-952', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Site PL4803', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '80803', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Site PL4805', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '04-730', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Site PL4801', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '110744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Site KR8207', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '120752', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Site KR8201', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '6100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Site TR9003', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Site TR9002', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'overallOfficials': [{'name': 'Clinical Study Manager', 'role': 'STUDY_CHAIR', 'affiliation': 'Astellas Pharma Europe B.V.'}]}, 'ipdSharingStatementModule': {'url': 'https://www.clinicaltrials.astellas.com/transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.', 'ipdSharing': 'YES', 'description': "Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.", 'accessCriteria': 'Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Europe B.V.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}