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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01655069
First Posted: August 1, 2012
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
  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: Intervention Model: Single Group Assignment
Masking: None (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 ( Astellas Pharma Europe B.V. ):

Primary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: Week 12 to Week 52 (End of study) ]

Secondary Outcome Measures:
  • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of incontinence episodes/24 hours [ Time Frame: Baseline and Week 52 ]
  • 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 ]
  • Change from baseline of study 905-CL-076 to end of this study in efficacy measured by mean number of micturitions/24 hours [ Time Frame: Baseline and Week 52 ]
  • 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 ]
  • Safety as assessed by recording laboratory tests, vital signs, urinalysis, PVR (post void residual) volume and electrocardiograms (ECGs) [ Time Frame: Week 52 ]

Enrollment: 148
Study Start Date: October 2012
Study Completion Date: October 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01655069


  Show 39 Study Locations
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Investigators
Study Chair: Clinical Study Manager Astellas Pharma Europe B.V.
  More Information

Additional Information:
Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT01655069     History of Changes
Other Study ID Numbers: 905-CL-077
2011-002047-10 ( EudraCT Number )
First Submitted: July 30, 2012
First Posted: August 1, 2012
Last Update Posted: October 12, 2017
Last Verified: July 2015

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
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 Succinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents