Urinary Bladder, OveractivePhase 3LEOPARDNCT01655069
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
A Phase 3 study testing Solifenacin succinate suspension in people with Urinary Bladder, Overactive, run by Astellas Pharma Europe B.V. at 39 sites in 16 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- Solifenacin succinate suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 39 sitesin 16 countries
- Study dates
- 4 Oct 2012to 8 Oct 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject has met the inclusion criteria of study 905-CL-076 and completed study 905-CL-076
Who cannot join
- Subject has failed the exclusion criteria of study 905-CL-076
Trial locations and contacts
39 sites in 16 countries.
39 sites in 16 countries
Belgium7 sites
Site: 3202
Antwerp, 2020
Site: 3209
Antwerp, 2650
Site: 3208
Charleroi, 6000
Site: 3201
Ghent, 9000
Site: 3203
Ghent, 9000
Site: 3204
Kortrijk, 8500
Site: 3205
Leuven, 3000
Denmark4 sites
Site: 4503
Aalborg, DK-9000
Site: 4501
Aarhus N, 8200
Site: 4504
Køge, 4600
Site: 4502
Kolding, 6000
Poland4 sites
Site: 4805
Gdansk, 80-803
Site: 4803
Gdansk, 80-952
Site: 4804
Lubin, 20-093
Site: 4801
Warsaw, 04-736
South Korea4 sites
Site: 8203
Daegu, 705717
Site: 8206
Incheon, 400-711
Site: 8207
Seoul, 110744
Site: 8202
Seoul, 156707
Sweden4 sites
Site: 4606
Gothenburg, 41685
Site: 4603
Skövde, 54185
Site: 4602
Stockholm, 11883
Site: 4605
Umeå, 90185
Serbia and Montenegro2 sites
Site: 3810
Belgrade, 11 000
Site: 3812
Novi Sad, 21000
Turkey (Türkiye)2 sites
Site: 9001
Ankara, 6100
Site: 9002
Izmir, 35100
United Kingdom2 sites
Site: 4403
Leeds, LS1 3EX
Site: 4401
Sheffield, S10 2TH
About this study
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)
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).
Read the 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.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Solifenacin succinate suspension
- Keywords
- Overactive bladder (OAB), Solifenacin succinate suspension, Phase 3, Pediatric
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solifenacin succinate suspensionDrug
Also called YM905, solifenacin succinate
Oral suspension
| Study group | Role | What they receive |
|---|---|---|
| Children Treated with Placebo in 905-CL-076 | Experimental | 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. Receives: Drug: Solifenacin succinate suspension |
| Children Treated with Solifenacin in 905-CL-076 | Experimental | 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. Receives: Drug: Solifenacin succinate suspension |
| Adolescents Treated with Placebo in 905-CL-076 | Experimental | 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. Receives: Drug: Solifenacin succinate suspension |
| Adolescents Treated with Solifenacin in 905-CL-076 | Experimental | 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. Receives: Drug: Solifenacin succinate suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study start4 Oct 2012
- Primary completion8 Oct 2014
- Study completion8 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Study Manager, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655069
- Sponsor's protocol ID
- 905-CL-077
- Other IDs
- 2011-002047-10
- Acronym
- LEOPARD
- Status last verified
- Oct 2024
- First submitted
- 30 Jul 2012
- Last updated
- 13 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01655069
- Acronym / sponsor ID
- LEOPARD / 905-CL-077
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Overactive bladder (OAB), Solifenacin succinate suspension, Phase 3, Pediatric
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2012 (actual)
- Primary completion
- 8 Oct 2014 (actual)
- Study completion
- 8 Oct 2014 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Posted 11 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children Treated with Placebo in 905-CL-076 | Experimental | Drug: Solifenacin succinate suspensionMale 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. |
| Children Treated with Solifenacin in 905-CL-076 | Experimental | Drug: Solifenacin succinate suspensionMale 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. |
| Adolescents Treated with Placebo in 905-CL-076 | Experimental | Drug: Solifenacin succinate suspensionMale 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. |
| Adolescents Treated with Solifenacin in 905-CL-076 | Experimental | Drug: Solifenacin succinate suspensionMale 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Subject has met the inclusion criteria of study 905-CL-076 and completed study 905-CL-076
Key exclusion criteria (1 listed)
- Subject has failed the exclusion criteria of study 905-CL-076
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Solifenacin succinate suspensionAlso: YM905, solifenacin succinateOral suspension | Drug | Adolescents Treated with Placebo in 905-CL-076, Adolescents Treated with Solifenacin in 905-CL-076, Children Treated with Placebo in 905-CL-076, Children Treated with Solifenacin in 905-CL-076 |
Primary outcome
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 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).
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.
5 secondary outcomes
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to results on EudraCTLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
Related trials for Urinary Bladder, Overactive
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
39 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solifenacin succinate suspension in people with Urinary Bladder, Overactive, run by Astellas Pharma Europe B.V. at 39 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Belgium, Denmark, Poland, South Korea, Sweden and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With and Severity of Treatment-Emergent Adverse Events (TEAEs) (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2024.