Clinical TrialID 5334
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
NCT01565694
Neurogenic Detrusor Overactivity
Relationship Network
Interactive first-hop connections across herbs, ingredients, formulas, targets, diseases, symptoms, syndromes, evidence, and monographs.
Click a node to open it in a new tab
Trial: 1Ingredient: 1Links: 1
Arranging relationship network...
Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5334
- Evidence Id
- 5334
- Core Evidence Id
- 5334
- Source Clinical Trial Id
- 5320
- Herb2 Clinical Trial Id
- HBCT005320
- Nct Id
- NCT01565694
- 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
- Status
- Completed
- Phase
- Phase 3
- Study Result
- Yes
- Study Condition
- Neurogenic Detrusor Overactivity
- Study Type
- Interventional
- Study Design
- Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Solifenacin succinate
- Intervention Allocation
- Intervention Model
- Single_Group
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Child
- Enrollment
- 76
- Outcome Measure
- Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC), 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., Baseline and Week 24
- Sponsor Collaborator
- Astellas Pharma Europe B.V.
- Funded By
- INDUSTRY
- Location
- Site US1008, Tarrytown, New York, 10591, United States|Site US1010, Cincinnati, Ohio, 45229-3039, United States|Site BE3201, Gent, 9000, Belgium|Site BR5505, Sao Jose do Rio Preto, São Paulo, 15090-000, Brazil|Site BR5507, Campinas, 13060-803, Brazil|Site BR5504, Campinas, 13083-887, Brazil|Site BR5506, Curitiba, 80240-060, Brazil|Site BR5503, Porto Alegre, 90035-903, Brazil|Site DK4501, Aarhus, 8200, Denmark|Site HU3602, Miskolc, 3526, Hungary|Site KR8207, Seoul, 110744, Korea, Republic of|Site KR8201, Seoul, 120752, Korea, Republic of|Site MX5203, Leon, 37000, Mexico|Site MX5205, Mexico City, C.P. 06700, Mexico|Site PH6301, Manila, 1015, Philippines|Site PH6302, Quezon City, 1101, Philippines|Site PL4803, Gdansk, 80-952, Poland|Site PL4805, Gdansk, 80803, Poland|Site PL4801, Warszawa, 04-730, Poland|Site TR9003, Ankara, 6100, Turkey|Site TR9002, Izmir, 35100, Turkey
- Other Id
- 905-CL-047|2011-000330-11
- Start Date
- 2012-08-14
- Primary Completion Date
- 2016-04-28
- Completion Date
- 2016-04-28
- First Posted
- 2012-03-29
- Results First Posted
- 2019-05-06
- Last Update Posted
- 2019-05-06
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01565694
- Title Cn
- Title En
- 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
- Bilingual Status
- semi_complete