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 BV )
ClinicalTrials.gov Identifier:
NCT01565707
First received: March 27, 2012
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: Solifenacin succinate
Drug: Placebo
Behavioral: Urotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 190
Study Start Date: June 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm 1
Active treatment arm
Drug: Solifenacin succinate
Oral suspension
Other Name: YM905
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
Placebo Comparator: Treatment arm 2
Placebo arm
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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565707

  Show 49 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe BV
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe BV
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe BV )
ClinicalTrials.gov Identifier: NCT01565707     History of Changes
Other Study ID Numbers: 905-CL-076, 2011-002066-20
Study First Received: March 27, 2012
Last Updated: January 23, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Canadian Institutes of Health Research
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Mexico: National Council of Science and Technology
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Norway: Norwegian Medicines Agency
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Pharmacological Committee, Ministry of Health
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
South Africa: Medicines Control Council
South Korea: Korea Food and Drug Administration (KFDA)
Sweden: Medical Products Agency
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Overactive bladder (OAB)
Pediatric
Solifenacin succinate suspension
Pharmacokinetics
Phase 3

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014