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 - Full Text View

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:

Drug Information available for: Succinic acid Solifenacin succinate

U.S. FDA Resources

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 ]

Estimated Enrollment:	240
Study Start Date:	June 2012
Estimated Study Completion Date:	January 2014
Estimated 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

Contacts

Contact: Global Clinical Sciences

+31 (0)71 54 55 878

contact@nl.astellas.com

Show 103 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:	February 7, 2013
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 May 19, 2013

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)