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)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT01655069
First received: July 30, 2012
Last updated: December 10, 2013
Last verified: December 2013
  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:


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: October 2014
Estimated Primary Completion Date: October 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
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: NCT01655069

  Show 80 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: NCT01655069     History of Changes
Other Study ID Numbers: 905-CL-077, 2011-002047-10
Study First Received: July 30, 2012
Last Updated: December 10, 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
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
United States: Food and Drug Administration

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
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 September 18, 2014