A Study to Investigate How Effective and Safe Solifenacin Liquid Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug (LION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01565707
First received: March 27, 2012
Last updated: January 23, 2014
Last verified: January 2014

March 27, 2012
January 23, 2014
June 2012
January 2014   (final data collection date for primary outcome measure)
Change from baseline to EoT (final visit) in mean volume voided per micturition [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
The mean voided volume will be determined using the patient diary data of two days (e.g., during the weekend).
Same as current
Complete list of historical versions of study NCT01565707 on ClinicalTrials.gov Archive Site
  • Change from baseline to EoT (final visit) in OAB symptoms [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    • Maximum volume voided per micturition.
    • Mean number of daytime incontinence episodes/24 h.
    • Mean number of nighttime incontinence episodes/24 h.
    • Mean number of incontinence episodes/24 h.
    • Number of dry (incontinence-free) days/7 days.
    • Mean number of daytime micturitions/24 h.
    • Mean number of micturitions/24h.
    • Mean number of grade 3 or 4 urgency episodes per 24 h in adolescents.
  • Safety as assessed by recording adverse events, laboratory assessments, vital signs and electrocardiograms (ECGs) [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Investigate How Effective and Safe Solifenacin Liquid Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)

Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed.

This study will investigate the effect and safety of solifenacin suspension compared to a non-active drug (placebo) over a 14-week period of daily treatment. The study will also investigate how well solifenacin suspension is taken-up by the body and how long it stays in the body during this time.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Urinary Bladder, Overactive
  • Drug: Solifenacin succinate
    Oral suspension
    Other Name: YM905
  • Drug: Placebo
    Oral suspension
  • Behavioral: Urotherapy
    Non interventional urotherapy consisting of OAB information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB.
    Other Name: Bladder training
  • Experimental: Treatment arm 1
    Active treatment arm
    Interventions:
    • Drug: Solifenacin succinate
    • Behavioral: Urotherapy
  • Placebo Comparator: Treatment arm 2
    Placebo arm
    Interventions:
    • Drug: Placebo
    • Behavioral: Urotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria
  • Daytime incontinence with at least 4 or more episodes of incontinence

Exclusion Criteria:

  • Daily voiding frequency less than 5
  • Uroflow indicative of pathology other than OAB
  • Maximum voided volume (morning volume excluded) > expected bladder capacity for age [(age +1) x 30] in ml or a maximum voided volume (morning volume excluded) above 390 ml
  • Post Void Residual (PVR) > 20 ml
  • Monosymptomatic enuresis
  • Congenital anomalies affecting lower urinary tract function
  • Current constipation
  • Current UTI
Both
5 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Brazil,   Canada,   Denmark,   Former Serbia and Montenegro,   Germany,   Korea, Republic of,   Mexico,   Norway,   Philippines,   Poland,   South Africa,   Sweden,   Turkey,   Ukraine,   United Kingdom
 
NCT01565707
905-CL-076, 2011-002066-20
Yes
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
Astellas Pharma Europe B.V.
Not Provided
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
Astellas Pharma Inc
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP