Urinary Bladder, OveractivePhase 3LIONNCT01565707
A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug
A Phase 3 study testing Solifenacin Succinate Suspension and Urotherapy in people with Urinary Bladder, Overactive, run by Astellas Pharma Europe B.V. at 46 sites in 16 countries.
Trial summary
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed. 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 and Urotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 189 participants
- Where
- 46 sitesin 16 countries
- Study dates
- 7 Jun 2012to 2 Jan 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
Main Inclusion Criteria:
- Written Informed Consent has been obtained
- OAB (symptoms of urgency) according to International Children's Continence Society (ICCS) criteria
- Daytime incontinence with at least 4 or more episodes of incontinence confirmed by 7 day participant diary
Main Exclusion Criteria:
- Daily voiding frequency less than 5
- Extraordinary daytime urinary frequency according to the International Children's Continence Society (ICCS) definition
- Uroflow indicative of pathology other than OAB
- Maximum voided volume (morning volume excluded) > expected bladder capacity for age [(age +1) x 30] in ml or a maximum voided volume (morning volume excluded) above 390 ml
- Post Void Residual (PVR) > 20 ml
- Monosymptomatic enuresis
- Polyuria defined as > 75 ml/kg/b.w./24 hours
- Dysfunctional voiding
- Congenital anomalies affecting lower urinary tract function
- Current constipation
- Current Urinary Tract Infection (UTI)
- Catheterization within 2 weeks prior to screening
Trial locations and contacts
46 sites in 16 countries.
46 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
South Korea5 sites
Site:8203
Daegu, 705717
Site: 8206
Incheon, 400-711
Site: 8207
Seoul, 110744
Site: 8201
Seoul, 120752
Site:8202
Seoul, 156707
Sweden5 sites
Site: 4606
Gothenburg, 41685
Site: 4601
Jönköping, 55185
Site: 4603
Skövde, 54185
Site: 4602
Stockholm, 11883
Site: 4605
Umeå, 90185
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
Ukraine3 sites
Site: 3853
Dnipropetrovsk, 49100
Site: 3854
Kharkiv
Site: 3850
Kiev, 1103
United States2 sites
Site: 1015
Albany, New York, 12208
Site: 1006
Shreveport, Louisiana, 71106
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: A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed.
This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Solifenacin Succinate Suspension, Placebo, Urotherapy
- Keywords
- Pediatric, Solifenacin succinate suspension, Phase 3, Pharmacokinetics, Overactive bladder (OAB)
- 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
Children aged 5 to 11 years and adolescents aged 12 to 17 years received solifenacin succinate liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary.
PlaceboDrug
Children aged 5 to 11 years and adolescents aged 12 to 17 years received matching placebo liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary.
UrotherapyBehavioural
Also called Bladder training
Non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Children | Placebo comparator | Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks. Receives: Drug: Placebo; Behavioral: Urotherapy |
| Solifenacin Succinate Suspension Children | Experimental | Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. Receives: Drug: Solifenacin Succinate Suspension; Behavioral: Urotherapy |
| Placebo Adolescents | Placebo comparator | Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks. Receives: Drug: Placebo; Behavioral: Urotherapy |
| Solifenacin Succinate Suspension Adolescents | Placebo comparator | Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. Receives: Drug: Solifenacin Succinate Suspension; Behavioral: Urotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition
The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence.
Measured: Baseline and Week 12
Secondary outcomes (19)
Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition
The mean daytime maximum volume voided (DMaxVV) was determined using the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the Baseline and end of treatment visits. The daytime maximum volume voided (DMaxVV) is the largest (non-zero) volume recorded over both of the 2 measuring days in the diary. The first morning void is excluded from the calculation. Daytime is defined as the time between waking up in the morning and going to bed later the same day. A micturition is any voluntary urination, excluding episodes of incontinence.
Measured: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
An incontinence episode is defined as an episode with any involuntary loss of urine. The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.
Measured: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Daytime is defined as the time between waking up in the morning and going to bed later the same day.
Measured: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
The mean number of incontinence episodes was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine. Nighttime is defined as the time between going to bed and waking up the following morning.
Measured: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days
The mean number of dry days was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.
Measured: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days
The mean number of dry nights was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. An incontinence episode is defined as an episode with any involuntary loss of urine.
Measured: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence.
Measured: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Daytime is defined as the time between waking up in the morning and going to bed later the same day.
Measured: Baseline and week 12
Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours
The mean number of micturitions was determined using the patient diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit. A micturition is any voluntary urination, excluding episodes of incontinence. Nighttime is defined as the time between going to bed and waking up the following morning.
Measured: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents
Adolescent participants were asked to record the degree of urgency associated with each micturition and incontinence episode according to the Patient Perception of Intensity of Urgency Scale (PPIUS) scale (0 - no urgency, 1 - mild urgency, 2 - moderate urgency, 3 - severe urgency, 4 - urge incontinence). The mean number of grade 3 or 4 urgency episodes was determined using using diary data recorded by the participant in the 7 days prior to baseline visit and end of treatment visit.
Measured: Baseline and Week 12
Maximum Concentration (Cmax) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. Cmax could not be calculated for 2 children and 1 adolescent in the Pharmacokinetic Analysis Set (PKAS).
Measured: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Time to Attain Maximum Concentration (Tmax) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. Tmax could not be calculated for 2 children and 1 adolescent in the PKAS.
Measured: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment. Ctrough could not be calculated for 2 children and 1 adolescent in the PKAS.
Measured: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment.
Measured: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment.
Measured: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Apparent Total Body Clearance (CL/F) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment.
Measured: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Apparent Volume of Distribution (Vz/F) of Solifenacin
Pharmacokinetic sampling was performed at steady state at the end of treatment.
Measured: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Number of Participants With Adverse Events (AEs)
A treatment emergent adverse event (TEAE) was defined as an AE that occurred after the first dose of study drug and within 7 days after last dose of study medication.
Measured: From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Change From Baseline in Post Void Residual (PVR) Volume
Post Void Residual (PVR) Volume was assessed by ultrasonography or bladder scan.
Measured: Baseline and Week 12
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 start7 Jun 2012
- Primary completion31 Dec 2013
- Study completion2 Jan 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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 189 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
- NCT01565707
- Sponsor's protocol ID
- 905-CL-076
- Other IDs
- 2011-002066-20
- Acronym
- LION
- Status last verified
- Oct 2024
- First submitted
- 27 Mar 2012
- Last updated
- 31 Oct 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 33231929Snijder R, Bosman B, Stroosma O, Agema M. Relationship between mean volume voided and incontinence in children with overactive bladder treated with solifenacin: post hoc analysis of a phase 3 randomised clinical trial. Eur J Pediatr. 2020 Oct;179(10):1523-1528. doi: 10.1007/s00431-020-03635-2. Epub 2020 Apr 1.
PubMed 32239291Newgreen D, Bosman B, Hollestein-Havelaar A, Dahler E, Besuyen R, Sawyer W, Bolduc S, Rittig S. Solifenacin in Children and Adolescents with Overactive Bladder: Results of a Phase 3 Randomised Clinical Trial. Eur Urol. 2017 Mar;71(3):483-490. doi: 10.1016/j.eururo.2016.08.061. Epub 2016 Sep 28.
PubMed 27687820
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-Blind, Randomized, Multi-center, Placebo-Controlled Sequential Dose Titration Study to Assess Efficacy, Safety and Population Pharmacokinetics of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Overactive Bladder (OAB)
- ClinicalTrials.gov ID
- NCT01565707
- Acronym / sponsor ID
- LION / 905-CL-076
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Pediatric, Solifenacin succinate suspension, Phase 3, Pharmacokinetics, Overactive bladder (OAB)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2012 (actual)
- Primary completion
- 31 Dec 2013 (actual)
- Study completion
- 2 Jan 2014 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Posted 30 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed.
This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo Children | Placebo comparator | Drug: Placebo, Behavioral: UrotherapyChildren aged 5 to 11 years received matching placebo suspension once a day for 12 weeks. |
| Solifenacin Succinate Suspension Children | Experimental | Drug: Solifenacin Succinate Suspension, Behavioral: UrotherapyChildren aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
| Placebo Adolescents | Placebo comparator | Drug: Placebo, Behavioral: UrotherapyAdolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks. |
| Solifenacin Succinate Suspension Adolescents | Placebo comparator | Drug: Solifenacin Succinate Suspension, Behavioral: UrotherapyAdolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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: YM905Children aged 5 to 11 years and adolescents aged 12 to 17 years received solifenacin succinate liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary. | Drug | Solifenacin Succinate Suspension Adolescents, Solifenacin Succinate Suspension Children |
| PlaceboChildren aged 5 to 11 years and adolescents aged 12 to 17 years received matching placebo liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary. | Drug | Placebo Adolescents, Placebo Children |
| UrotherapyAlso: Bladder trainingNon interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. | Behavioural | Placebo Adolescents, Placebo Children, Solifenacin Succinate Suspension Adolescents, Solifenacin Succinate Suspension Children |
Primary outcome
Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition
Time frame: Baseline and Week 12
The mean voided volume was calculated from the participant diary data recorded during two measuring days (i.e., those days when the participant recorded the volume of each micturition) in the 7 days prior to the baseline and end of treatment visits. The MVV is equal to the mean of the non-zero volumes recorded over the 2 measuring days. A micturition is any voluntary urination, excluding episodes of incontinence.
19 secondary outcomes
Change From Baseline to End of Treatment in Daytime Maximum Volume Voided (DMaxVV) Per Micturition
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Incontinence Episodes Per 24 Hours
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Daytime Incontinence Episodes Per 24 Hours
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Nighttime Incontinence Episodes Per 24 Hours
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Days Per 7 Days
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Dry (Incontinence-Free) Nighttimes Per 7 Days
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Micturitions Per 24 Hours
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Daytime Micturitions Per 24 Hours
Time frame: Baseline and week 12
Change From Baseline to End of Treatment in Mean Number of Nighttime Micturitions Per 24 Hours
Time frame: Baseline and Week 12
Change From Baseline to End of Treatment in Mean Number of Grade 3 or 4 Urgency Episodes Per 24 Hours in Adolescents
Time frame: Baseline and Week 12
Maximum Concentration (Cmax) of Solifenacin
Time frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Time to Attain Maximum Concentration (Tmax) of Solifenacin
Time frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Plasma Concentration Before Drug Administration (Ctrough) of Solifenacin
Time frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Area Under the Plasma Concentration - Time to Curve (AUC) for a Dose Interval (AUCtau) of Solifenacin
Time frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Apparent Terminal Elimination Half-Life (T1/2) of Solifenacin
Time frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Apparent Total Body Clearance (CL/F) of Solifenacin
Time frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Apparent Volume of Distribution (Vz/F) of Solifenacin
Time frame: Week 12/Day 84 (within 3 hours before dosing, 1-3 hours, 4-5 hours, 7-10 hours after dosing) and one sample at Visit 8/Day 87 (2-3 days after last dose intake).
Number of Participants With Adverse Events (AEs)
Time frame: From the first dose of study drug until 7 days after last dose of study medication (13 weeks).
Change From Baseline in Post Void Residual (PVR) Volume
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 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 32239291Snijder R, Bosman B, Stroosma O, Agema M. Relationship between mean volume voided and incontinence in children with overactive bladder treated with solifenacin: post hoc analysis of a phase 3 randomised clinical trial. Eur J Pediatr. 2020 Oct;179(10):1523-1528. doi: 10.1007/s00431-020-03635-2. Epub 2020 Apr 1.
- Derived from this study: PubMed 27687820Newgreen D, Bosman B, Hollestein-Havelaar A, Dahler E, Besuyen R, Sawyer W, Bolduc S, Rittig S. Solifenacin in Children and Adolescents with Overactive Bladder: Results of a Phase 3 Randomised Clinical Trial. Eur Urol. 2017 Mar;71(3):483-490. doi: 10.1016/j.eururo.2016.08.061. Epub 2016 Sep 28.
- 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/.
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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.
46 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 and Urotherapy in people with Urinary Bladder, Overactive, run by Astellas Pharma Europe B.V. at 46 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?
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 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Belgium, South Korea, Sweden, Denmark, Poland 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. Some participants in this study may receive a placebo. 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 30 Jan 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?
Change From Baseline to End of Treatment (EoT) in Mean Volume Voided (MVV) Per Micturition (time frame: Baseline and Week 12). 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 NCT01565707, which also lists 3 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 31 Oct 2024.