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)

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)

This was a 40-week study to investigate how safe and effective solifenacin solution was in treating children or adolescents with symptoms of overactive bladder (OAB), who completed study 905-CL-076 (NCT01565707).

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive
• Intervention / Treatment: Drug: Solifenacin succinate suspension

Detailed Description

There was a titration period of up to 12 weeks during which the participants would be up or down-titrated based on a combination of efficacy and safety parameters followed by a fixed dose period during which no dose adjustments were allowed. Participants completed a 7-day patient diary prior to every visit (start of 905-CL-076 to end of 905-CL-077, 14 visits). The first visit of this study (905-CL-077) was combined with the last visit of the 4-month study 905-CL-076. At each visit, the participant was 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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2020
    • Site: 3202
  • Antwerp, Belgium, 2650
    • Site: 3209
  • Charleroi, Belgium, 6000
    • Site: 3208
  • Gent, Belgium, 9000
    • Site: 3201
  • Gent, Belgium, 9000
    • Site: 3203
  • Kortrijk, Belgium, 8500
    • Site: 3204
  • Leuven, Belgium, 3000
    • Site: 3205
• Brazil
  • Campinas, Brazil, 13087-567
    • Site: 5507
  • Curitiba, Brazil, 80240-060
    • Site: 5506
• Canada
  • Quebec, Canada, G1V 4G2
    • Site: 1001
• Denmark
  • Aalborg, Denmark, DK-9000
    • Site: 4503
  • Aarhus N, Denmark, 8200
    • Site: 4501
  • Koge, Denmark, 4600
    • Site: 4504
  • Kolding, Denmark, 6000
    • Site: 4502
• Former Serbia and Montenegro
  • Belgrade, Former Serbia and Montenegro, 11 000
    • Site: 3810
  • Novi Sad, Former Serbia and Montenegro, 21000
    • Site: 3812
• Korea, Republic of
  • Daegu, Korea, Republic of, 705717
    • Site: 8203
  • Incheon, Korea, Republic of, 400-711
    • Site: 8206
  • Seoul, Korea, Republic of, 110744
    • Site: 8207
  • Seoul, Korea, Republic of, 156707
    • Site: 8202
• Mexico
  • Mexico City, Mexico, 4530
    • Site: 5202
  • Mexico City, Mexico, C.P.06700
    • Site: 5205
• Norway
  • Bergen, Norway, 5021
    • Site: 4701
• Philippines
  • Quezon City, Philippines, 1108
    • Site: 6301
• Poland
  • Gdansk, Poland, 80-803
    • Site: 4805
  • Gdansk, Poland, 80-952
    • Site: 4803
  • Lubin, Poland, 20-093
    • Site: 4804
  • Warsaw, Poland, 04-736
    • Site: 4801
• South Africa
  • Cape Town, South Africa, 7700
    • Site: 2703
• Sweden
  • Gothenburg, Sweden, 41685
    • Site: 4606
  • Skovde, Sweden, 54185
    • Site: 4603
  • Stockholm, Sweden, 11883
    • Site: 4602
  • Umea, Sweden, 90185
    • Site: 4605
• Turkey
  • Ankara, Turkey, 6100
    • Site: 9001
  • Izmir, Turkey, 35100
    • Site: 9002
• Ukraine
  • Kharkiv, Ukraine
    • Site: 3854
• United Kingdom
  • Leeds, United Kingdom, LS1 3EX
    • Site: 4403
  • Sheffield, United Kingdom, S10 2TH
    • Site: 4401
• United States
  • Louisiana
    • Shreveport, Louisiana, United States, 71106
      • Site: 1006

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Children Treated with Placebo in 905-CL-076; Male and female children aged 5 to less than 12 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.	Drug: Solifenacin succinate suspension; Oral suspension; Other Names: YM905; solifenacin succinate
EXPERIMENTAL: Children Treated with Solifenacin in 905-CL-076; Male and female children aged 5 to less than 12 years old who received solifenacin in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 247.9 days in children.	Drug: Solifenacin succinate suspension; Oral suspension; Other Names: YM905; solifenacin succinate
EXPERIMENTAL: Adolescents Treated with Placebo in 905-CL-076; Male and female adolescents aged 12 to less than 18 years old who received placebo in Study 905-CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.	Drug: Solifenacin succinate suspension; Oral suspension; Other Names: YM905; solifenacin succinate
EXPERIMENTAL: Adolescents Treated with Solifenacin in 905-CL-076; Male and female adolescents aged 12 to less than 18 years old who received solifenacin in Study 905- CL-076 and received open-label solifenacin once daily in this study. The mean time on study drug in this study was 240.1 days in adolescents.	Drug: Solifenacin succinate suspension; Oral suspension; Other Names: YM905; solifenacin succinate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)	The investigator assessed the severity of AEs, including abnormal clinical laboratory values, electrocardiogram (ECG), vital signs, as follows: Mild: No disruption of normal daily activities; Moderate: Affect normal daily activities; Severe: Inability to perform daily activities. In participants treated with placebo in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of open-label solifenacin in Study 905-CL-077 up to 7 days after the last dose of solifenacin. In participants treated with solifenacin in Study 905-CL-076, a TEAE was defined as an AE that started/worsened after the first dose of double-blind solifenacin in Study 905-CL-076 up to 7 days after last dose of open-label solifenacin in Study 905-CL-077.	From first dose of solifenacin (in Study 905-CL-076 or in current study) up to 7 days after last dose of open-label solifenacin (41 weeks for participants who received placebo in 076 and 53 weeks for those who received solifenacin in 076).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours	The mean number of incontinence episodes was based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. An Incontinence episode is defined as an episode with any involuntary loss of urine. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.	Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days	The number of dry (incontinence-free) days was based on 7-day diary data completed by participants prior to each visit from start of 905-C L-076 to end of 905-C L-077. An incontinence-free day is a day without any incontinence episodes. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.	Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Change From Baseline in Mean Number of Micturitions Per 24 Hours	The mean number of micturitions (urinations) was based on 7-day diary data completed by participants prior to each visit from start of 905-CL-076 to end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.	Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Change From Baseline in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents	Adolescent participants were also asked to record urgencies for at least 2 of the 7 diary days using the Perception of Intensity of Urgency Scale (PPIUS): (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). This data is based on 7-day diary data completed by participants prior to each visit from the start of 905-CL-076 to the end of 905-CL-077. Data are reported by duration of solifenacin treatment based on the number of days from the date of first dose of solifenacin in either study 905-CL-076 or 905-CL-077 up to and including the study visit. Using equivalent treatment duration periods, data were combined for participants who received placebo and solifenacin in study 905-CL-076 within each age group.	Baseline (of 905-CL-076 study) and after 3, 6, 9, 12, 24, 40, and 52 weeks of solifenacin treatment
Change From Baseline to Final Visit in Postvoid Residual (PVR) Volume	PVR volume was assessed by ultrasonography or bladder scan during 905-CL-076 and 905-CL-077. The value reported is the last PVR volume value after first dose of solifenacin up to 52 weeks.	Baseline (of 905-CL-076 study) to final Visit (the most recent value after first dose of solifenacin up to 40 weeks for participants who received placebo in 076 and 52 weeks for those who received solifenacin in 076.)

Collaborators and Investigators

• Sponsor: Astellas Pharma Europe B.V.

Publications and helpful links

Helpful Links

• Link to results on EudraCT
• Link to results on the Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 4, 2012
• Primary Completion (ACTUAL): October 8, 2014
• Study Completion (ACTUAL): October 8, 2014

Study Registration Dates

• First Submitted: July 30, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (ESTIMATE): August 1, 2012

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Pediatric; Phase 3; Overactive bladder (OAB); Solifenacin succinate suspension
• Additional Relevant MeSH Terms: Urologic Diseases; Urinary Bladder Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder, Overactive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Urological Agents; Solifenacin Succinate
• Other Study ID Numbers: 905-CL-077; 2011-002047-10 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access to anonymized individual participant level data collected during the trial, in addition to study-related supporting documentation, is planned for trials conducted with approved product indications and formulations, as well as compounds terminated during development. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
• IPD Sharing Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• IPD Sharing Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No