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
  Purpose

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.


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: solifenacin suspension
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • AUC extrapolated until time is infinity (AUCinf) [ Time Frame: day 1 through day 7 post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 42
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment group 1
adolescents - lowest group
Drug: solifenacin suspension
oral suspension
Experimental: treatment group 2
adolescents - middle dose
Drug: solifenacin suspension
oral suspension
Experimental: treatment group 3
children - lowest dose
Drug: solifenacin suspension
oral suspension
Experimental: treatment group 4
adolescents - highest dose
Drug: solifenacin suspension
oral suspension
Experimental: treatment group 5
children - middle dose
Drug: solifenacin suspension
oral suspension
Experimental: treatment group 6
children - highest dose
Drug: solifenacin suspension
oral suspension

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262391

Locations
Belgium
Ghent, Belgium, 9000
Kortrijk, Belgium, 8500
Denmark
Arhus, Denmark, 8200
Sweden
Goteborg, Sweden, 41685
Uppsala, Sweden, 75185
United Kingdom
Cambridge, United Kingdom, CB2 2QQ
Manchester, United Kingdom, M13 9WL
Sheffield, United Kingdom, S10 2TH
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01262391     History of Changes
Other Study ID Numbers: 905-CL-075, 2009-017197-21
Study First Received: November 1, 2010
Last Updated: August 31, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:
Overactive bladder
Pediatric
Pharmacokinetics
Single-dose
Solifenacin suspension

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Solifenacin
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014