Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01262391
First received: November 1, 2010
Last updated: August 31, 2011
Last verified: August 2011

November 1, 2010
August 31, 2011
October 2010
August 2011   (final data collection date for primary outcome measure)
AUC extrapolated until time is infinity (AUCinf) [ Time Frame: day 1 through day 7 post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01262391 on ClinicalTrials.gov Archive Site
Assessment of safety through evaluation of adverse events, vital signs and ECG [ Time Frame: day 1 through day 7 post-dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents
A Multicenter, Open-label, Single Ascending Dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Patients Aged 5 to 17 Years (Inclusive) With Overactive Bladder (OAB)

This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder.

This is a multicenter, open-label, sequential, single ascending dose study. The study will consist of three treatment groups in children and three treatment groups in adolescents, targeting equivalent exposure to the 2.5, 5 and 10 mg doses o.d. in adults at steady state. The study will be conducted in pediatric OAB patients to establish the single-dose PK and the acute safety profile of solifenacin aqueous suspension. Each of the six groups will consist of at least six patients.

The study will start with the lowest dose group in adolescent patients (12 to 17 years). When this group has completed the study, their safety and concentration data will be reviewed by a Safety Review Committee. If no safety concerns are evident according to pre-specified criteria, enrollment of children (5 to 11 years) in the lowest dose group and adolescents in the intermediate dose group will be started simultaneously. When these groups have completed the study, their safety data and drug concentration data will also be reviewed. If no safety concerns occurred, enrollment of children in the intermediate dose group and of adolescents in the highest dose group will be started simultaneously. Finally, after these groups completed the study and no safety concerns occurred during associated data review, enrollment of children in the highest dose group will start. Interim review of plasma exposure at lower doses will be used to adjust the next higher doses administered, if necessary.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urinary Bladder, Overactive
Drug: solifenacin suspension
oral suspension
  • Experimental: treatment group 1
    adolescents - lowest group
    Intervention: Drug: solifenacin suspension
  • Experimental: treatment group 2
    adolescents - middle dose
    Intervention: Drug: solifenacin suspension
  • Experimental: treatment group 3
    children - lowest dose
    Intervention: Drug: solifenacin suspension
  • Experimental: treatment group 4
    adolescents - highest dose
    Intervention: Drug: solifenacin suspension
  • Experimental: treatment group 5
    children - middle dose
    Intervention: Drug: solifenacin suspension
  • Experimental: treatment group 6
    children - highest dose
    Intervention: Drug: solifenacin suspension
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Symptoms of urgency, diagnosed as OAB according to International Children's Continence Society (ICCS) criteria
  • Daytime urgency incontinence at least once/day

Exclusion Criteria:

  • Daytime voiding frequency less than 5
  • Uroflow indicative of pathology other than OAB
  • Maximum voided volume > age expected capacity ([age +1] x 30) in ml
  • Post voiding residual (PVR) > 10% of the functional bladder capacity
  • Monosymptomatic enuresis
  • Congenital anomalies of the genito-urinary tract or nervous system
  • Current constipation (when treated the patient can enter the study)
  • Current urinary tract infection (patient will be eligible for enrolment 14 days after a negative dipstick test, provided a second dipstick test, performed after these 14 days, is also negative)
  • Serum creatinine more than or equal to 2 times the upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than or equal to 2 times ULN, or bilirubin more than or equal to 1.5 times ULN
Both
5 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   Sweden,   United Kingdom
 
NCT01262391
905-CL-075, 2009-017197-21
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use Central Contact Astellas Pharma Europe B.V.
Astellas Pharma Inc
August 2011

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