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
  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
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: NCT01565707

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

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
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
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 August 26, 2014