Neurogenic Detrusor OveractivityPhase 3NCT01565694
A Study to Assess the Long Term Effect, Safety and Metabolism of a Solifenacin Liquid Suspension in Participants 5 to 18 Years of Age With Neurogenic Detrusor Overactivity
A Phase 3 study testing Solifenacin succinate in people with Neurogenic Detrusor Overactivity, run by Astellas Pharma Europe B.V. at 21 sites in 10 countries.
Trial summary
The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Neurogenic Detrusor Overactivity
- What is being tested?
- Solifenacin succinate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 21 sitesin 10 countries
- Study dates
- 14 Aug 2012to 28 Apr 2016
- 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
- Documented diagnosis of NDO, confirmed by urodynamics
- Practicing clean intermittent catheterization (CIC)
- Currently on treatment with an antimuscarinic drug
Who cannot join
- Known genitourinary condition (other than NDO) that may cause incontinence
- Bladder augmentation surgery
- Current Faecal impaction
- Electro-stimulation therapy within 2 weeks prior to screening and at any time during the study
- Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention
- Reflux grade 3 or 4
Show all 10Show fewer
- Current urinary tract infection (UTI)
- Subject has severe renal impairment (glomerular filtration rate < 30 ml/min)
- Subject has severe hepatic impairment (Child-Pugh score > 9).
- Subject has received intra-vesical botulinum toxin within 9 months prior to screening
Trial locations and contacts
21 sites in 10 countries.
21 sites in 10 countries
Brazil5 sites
Site BR5507
Campinas, 13060-803
Site BR5504
Campinas, 13083-887
Site BR5506
Curitiba, 80240-060
Site BR5503
Porto Alegre, 90035-903
Site BR5505
São José do Rio Preto, São Paulo, 15090-000
Poland3 sites
Site PL4803
Gdansk, 80-952
Site PL4805
Gdansk, 80803
Site PL4801
Warsaw, 04-730
United States2 sites
Site US1010
Cincinnati, Ohio, 45229-3039
Site US1008
Tarrytown, New York, 10591
Turkey (Türkiye)2 sites
Site TR9003
Ankara, 6100
Site TR9002
Izmir, 35100
About this study
Official title: A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)
The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
Read the detailed description
The NDO often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal during filling. These patients often have an inability to void, so that catheterization is required to empty the bladder.
The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets are given to adults for the treatment of overactive bladder. A new liquid suspension has been developed to treat children and adolescents in this and other studies.
The efficacy and safety of the solifenacin suspension was investigated. The take-up and length of time that the solifenacin suspension stays in the body was also investigated during this study. Effectiveness was measured by urodynamics (the filling and emptying of the bladder) and the urine volumes during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days.
Safety assessments included analysis of the blood and urine, review of the electrocardiogram (ECG), ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).
- Conditions
- Neurogenic Detrusor Overactivity
- Being tested
- Solifenacin succinate
- Keywords
- Cognitive Function, Phase 3, Neurogenic Detrusor Overactivity, Pharmacokinetics, Ocular Accommodation, Urodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Solifenacin succinateDrug
Also called YM905
Oral suspension administered once a day via syringe.
| Study group | Role | What they receive |
|---|---|---|
| Solifenacin succinate | Experimental | Participants aged 5 years to < 18 years received solifenacin orally once a day, with sequential titrated doses for 12 weeks to identify the optimal dose during the dose-titration period. The initial dose was pediatric equivalent dose (PED) 5 mg.
After completing the dose titration period participants entered the fixed-dose period during which solifenacin was taken orally once a day for 40 weeks or until the end of study visit (Week 52). Receives: Drug: Solifenacin succinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.
Measured: Baseline and Week 24
Secondary outcomes (15)
Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity
During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed. Based on study requirements, the last possible titration step was Week 9 for participants enrolled under versions 1.0 and 1.1 and Week 12 under later versions.
Measured: Baseline, Week 9 or Week 12
Change From Baseline in Bladder Compliance
Bladder compliance gives an indication of the elasticity of the bladder wall and was calculated by dividing the change in volume by the change in detrusor pressure during the filling of the bladder.
Measured: Baseline and Week 24
Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)
Change from baseline in the bladder volume was calculated using urodyanamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. If no detrusor contraction of at least 15 cmH2O occurs, the bladder volume was imputed with MCC.
Measured: Baseline and Week 24
Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure
Bladder volumes at 30 cm H2O detrusor pressure was calculated using the urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the participants experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.
Measured: Baseline and Week 24
Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure
Bladder volumes at 40 cm H2O detrusor pressure were calculated using urodynamic assessments. During urodynamic assessments, the bladder is filled until voiding/leakage begins, or until it is stopped because either the subject experiences pain or discomfort or 135% of expected bladder capacity for age has been reached.
Measured: Baseline and Week 24
Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling
Change from baseline in number of overactive detrusor contractions until end of bladder filling was measured by urodynamic testing. If leakage occurred, the "Detrusor pressure at leakage" was recorded otherwise the volume of fluid instilled into the bladder was recorded.
Measured: Baseline to Week 24
Change From Baseline in Detrusor Pressure at the End of Bladder Filling
The bladder was filled until voiding/leakage began or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. Pressure was recorded for an extra 5 minutes after leakage began or the end of bladder-filling, whichever is sooner.
Measured: Baseline to Week 24
Change From Baseline in Average Catheterized Volume Per Catheterization
The average catheterized volume per catheterization was calculated using all available (non-zero) catheterized volumes recorded over both of the 2 measuring days in the diary, whether or not these 2 days are concurrent.
Measured: Baseline to Week 24
Change From Baseline in Maximum Catheterized Volume
The maximum catheterized volume per day was calculated using all available (non-zero) catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days were concurrent. The maximum value was calculated separately for each measuring day and the mean of these two values was used.
Measured: Baseline to Week 24
Change From Baseline in Average First Morning Catheterized Volume
The average first morning catheterized volume was calculated as the average of the available first morning catheterized volumes recorded for the 2 measuring days in the diary, whether or not these 2 days are concurrent.
Measured: Baseline to Week 24
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
The mean of the number of incontinence episodes per 24h was calculated as the mean over the valid diary days in the 7-day diary.
Measured: Baseline to Week 24
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days
The number of incontinence-free days was calculated from the 7-day micturition diary.
Measured: Baseline to Week 24
Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days
The number of incontinence-free nights was calculated from the 7-day micturition diary.
Measured: Baseline to Week 24
Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)
Pediatric Incontinence Questionnaire (PinQ) is a 20-item questionnaire addressing quality of life for participants with bladder disorders. Each question was answered on a scale from 0 (no, never) to 4 (all the time). The total score ranged from 0 to 80, with higher scores indicated more impact on the quality of life.
Measured: Baseline to Week 24
Number of Participants With Adverse Events
A treatment-emergent adverse event (TEAE) was defined as an adverse event observed after starting administration of the first dose of study medication on Day 1. All adverse events collected within 7 days after taking the last dose of study drug were counted as a TEAE.
Measured: Baseline to End of Study Visit (Week 52)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study start14 Aug 2012
- Primary completion28 Apr 2016
- Study completion28 Apr 2016
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Detrusor OveractivityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 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
- NCT01565694
- Sponsor's protocol ID
- 905-CL-047
- Other IDs
- 2011-000330-11
- Status last verified
- Oct 2024
- First submitted
- 27 Mar 2012
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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/.
Publications
Tannenbaum S, den Adel M, Krauwinkel W, Meijer J, Hollestein-Havelaar A, Verheggen F, Newgreen D. Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity. Pharmacol Res Perspect. 2020 Dec;8(6):e00684. doi: 10.1002/prp2.684.
PubMed 33231929Franco I, Hoebeke P, Baka-Ostrowska M, Bolong D, Davies LN, Dahler E, Snijder R, Stroosma O, Verheggen F, Newgreen D, Bosman B, Vande Walle J. Long-term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open-label studies. J Pediatr Urol. 2020 Apr;16(2):180.e1-180.e8. doi: 10.1016/j.jpurol.2019.12.012. Epub 2019 Dec 27.
PubMed 32007426
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open-Label, Baseline-controlled, Multicenter, Sequential Dose Titration Study to Assess the Long-Term Efficacy and Safety, and the Pharmacokinetics of Solifenacin Succinate Suspension in Patients From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)
- ClinicalTrials.gov ID
- NCT01565694
- Acronym / sponsor ID
- 905-CL-047
- Conditions
- Neurogenic Detrusor Overactivity
- Keywords
- Cognitive Function, Phase 3, Neurogenic Detrusor Overactivity, Pharmacokinetics, Ocular Accommodation, Urodynamics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2012 (actual)
- Primary completion
- 28 Apr 2016 (actual)
- Study completion
- 28 Apr 2016 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Posted 6 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to investigate a medicine for the treatment of symptoms and complications of neurogenic detrusor overactivity (NDO) in children and adolescents.
Detailed description
The NDO often occurs in patients with spina bifida or other spinal cord damage where the bladder muscle contracts more than normal during filling. These patients often have an inability to void, so that catheterization is required to empty the bladder.
The medicine being tested in this study is called solifenacin succinate. Solifenacin tablets are given to adults for the treatment of overactive bladder. A new liquid suspension has been developed to treat children and adolescents in this and other studies.
The efficacy and safety of the solifenacin suspension was investigated. The take-up and length of time that the solifenacin suspension stays in the body was also investigated during this study. Effectiveness was measured by urodynamics (the filling and emptying of the bladder) and the urine volumes during catheterization together with the diary responses relating to the number of incontinence episodes or incontinence free days.
Safety assessments included analysis of the blood and urine, review of the electrocardiogram (ECG), ultrasound of the kidney, simple memory and understanding tests (cognitive function) and the ability to see near and far objects (visual accommodation).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Solifenacin succinate | Experimental | Drug: Solifenacin succinateParticipants aged 5 years to < 18 years received solifenacin orally once a day, with sequential titrated doses for 12 weeks to identify the optimal dose during the dose-titration period. The initial dose was pediatric equivalent dose (PED) 5 mg. After completing the dose titration period participants entered the fixed-dose period during which solifenacin was taken orally once a day for 40 weeks or until the end of study visit (Week 52). |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Documented diagnosis of NDO, confirmed by urodynamics
- Practicing clean intermittent catheterization (CIC)
- Currently on treatment with an antimuscarinic drug
Key exclusion criteria (10 listed)
- Known genitourinary condition (other than NDO) that may cause incontinence
- Bladder augmentation surgery
- Current Faecal impaction
- Electro-stimulation therapy within 2 weeks prior to screening and at any time during the study
- Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention
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 succinateAlso: YM905Oral suspension administered once a day via syringe. | Drug | Solifenacin succinate |
Primary outcome
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC)
Time frame: Baseline and Week 24
During urodynamic assessments, the bladder was filled until voiding/leakage begins, or until it was stopped because either the participant experiences pain or discomfort or 135% of expected bladder capacity for age has been reached. MCC is the maximum bladder capacity reached during filling cystometry before either leakage or pain/discomfort was observed.
15 secondary outcomes
Change From Baseline to Last Possible Titration Step in Maximum Cystometric Capacity
Time frame: Baseline, Week 9 or Week 12
Change From Baseline in Bladder Compliance
Time frame: Baseline and Week 24
Change From Baseline in Bladder Volume (mL) Until First Detrusor Contraction > 15 cmH2O as a Percentage of Expected Bladder Capacity (EBC)
Time frame: Baseline and Week 24
Change From Baseline in Bladder Volume at 30 cmH2O Detrusor Pressure
Time frame: Baseline and Week 24
Change From Baseline in Bladder Volume at 40 cmH2O Detrusor Pressure
Time frame: Baseline and Week 24
Change From Baseline in Number of Overactive Detrusor Contractions (> 15 cmH2O) Until End of Bladder Filling
Time frame: Baseline to Week 24
Change From Baseline in Detrusor Pressure at the End of Bladder Filling
Time frame: Baseline to Week 24
Change From Baseline in Average Catheterized Volume Per Catheterization
Time frame: Baseline to Week 24
Change From Baseline in Maximum Catheterized Volume
Time frame: Baseline to Week 24
Change From Baseline in Average First Morning Catheterized Volume
Time frame: Baseline to Week 24
Change From Baseline in Mean Number of Incontinence Episodes Per 24 Hours
Time frame: Baseline to Week 24
Change From Baseline in Number of Dry (Incontinence-Free) Days Per 7 Days
Time frame: Baseline to Week 24
Change From Baseline in Number of Dry (Incontinence-Free) Nights Per 7 Days
Time frame: Baseline to Week 24
Change From Baseline in Quality of Life [QoL] (PinQ Questionnaire Score)
Time frame: Baseline to Week 24
Number of Participants With Adverse Events
Time frame: Baseline to End of Study Visit (Week 52)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33231929Tannenbaum S, den Adel M, Krauwinkel W, Meijer J, Hollestein-Havelaar A, Verheggen F, Newgreen D. Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity. Pharmacol Res Perspect. 2020 Dec;8(6):e00684. doi: 10.1002/prp2.684.
- Derived from this study: PubMed 32007426Franco I, Hoebeke P, Baka-Ostrowska M, Bolong D, Davies LN, Dahler E, Snijder R, Stroosma O, Verheggen F, Newgreen D, Bosman B, Vande Walle J. Long-term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open-label studies. J Pediatr Urol. 2020 Apr;16(2):180.e1-180.e8. doi: 10.1016/j.jpurol.2019.12.012. Epub 2019 Dec 27.
- 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 Neurogenic Detrusor Overactivity
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Neurogenic Detrusor Overactivity, Spinal Cord Injuries
Not yet recruiting
TTNS in SCI Patients With Neurogenic Detrusor Overactivity
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RecruitingPhase 2/3
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Neurogenic Detrusor Overactivity
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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.
21 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Solifenacin succinate in people with Neurogenic Detrusor Overactivity, run by Astellas Pharma Europe B.V. at 21 sites in 10 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 3 inclusion and 10 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 14 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 21 sites in Brazil, Poland, United States, Mexico, Philippines and 5 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 6 May 2019). 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?
Change From Baseline to Week 24 in Maximum Cystometric Capacity (MCC) (time frame: Baseline and Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01565694, which also lists 2 linked publications.
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 14 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.