A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076 - Full Text View

Purpose

This is a 40-week study to investigate how safe and effective solifenacin solution is in treating children/adolescents with symptoms of overactive bladder (OAB) who completed study 905-CL-076. To measure the efficacy of the treatment the patient will complete a 7-day patient diary prior to every visit, starting at Visit 9. The patient will attend the study clinic on 7 separate occasions. The first visit of this study (905-CL-077) will be combined with the last visit of the 4-month study 905-CL-076. At each visit, the patient will be required to undertake a number of assessments or examinations to determine whether it is safe for him/her to take part or to continue to take part in the study. During the first 3 visits the dosage of the study drug will be adjusted if needed in order to optimize the most effective and safe dose for each patient.

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

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open-Label, Long-Term Extension, Multi-center, Sequential Dose Titration Study to Assess Safety and Efficacy of Solifenacin Succinate Suspension in Pediatric Subjects 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:

Incidence and severity of adverse events [ Time Frame: Week 12 to Week 52 (End of study) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of daytime incontinence episodes/24 hours [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of nighttime incontinence episodes/24 hours [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Change from baseline of study 905-CL-076 to end of this study in efficacy measured by number of dry (incontinence-free) days/7 days [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of daytime micturitions/24 hours [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of grade 3 or 4 urgency episodes per 24 hours in adolescents [ Time Frame: Baseline and Week 52 ] [ Designated as safety issue: No ]
Safety as assessed by recording laboratory tests, vital signs, urinalysis, PVR (post void residual) volume and electrocardiograms (ECGs) [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	October 2012
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Solifenacin	Drug: Solifenacin succinate Oral suspension Other Name: YM905

Eligibility

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

Criteria

Inclusion Criteria:

Subject has met the inclusion criteria of study 905-CL-076 and completed study 905-CL-076

Exclusion Criteria:

Subject has failed the exclusion criteria of study 905-CL-076

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655069

Show 93 Study Locations

Sponsors and Collaborators

Astellas Pharma Europe BV

Investigators

Study Chair:

Clinical Study Manager

Astellas Pharma Europe B.V.

More Information

No publications provided

Responsible Party:	Astellas Pharma Inc ( Astellas Pharma Europe BV )
ClinicalTrials.gov Identifier:	NCT01655069 History of Changes
Other Study ID Numbers:	905-CL-077, 2011-002047-10
Study First Received:	July 30, 2012
Last Updated:	March 19, 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: Ethics Committee Ukraine: State Pharmacological Center - Ministry of Health United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Astellas Pharma Inc:

Overactive bladder (OAB)
Pediatric
Solifenacin succinate suspension
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 22, 2013

A Study to Investigate How Safe and Effective Solifenacin Solution is in Treating Children/Adolescents With Symptoms of Overactive Bladder (OAB) Who Completed Study 905-CL-076 (LEOPARD)