Urinary Bladder, OveractivePhase 1NCT01262391
Single-dose Study to Assess Pharmacokinetics of Solifenacin Succinate Suspension in Children and Adolescents
A Phase 1 study testing Solifenacin succinate suspension 2.5 mg, Solifenacin succinate suspension 5 mg and Solifenacin succinate suspension 10 mg in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 8 sites in 4 countries.
Trial summary
This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder. 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 2.5 mg, Solifenacin succinate suspension 5 mg and Solifenacin succinate suspension 10 mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 20 Oct 2010to 14 Aug 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Symptoms of urgency, diagnosed as OAB according to International Children's Continence Society (ICCS) criteria
- Daytime urgency incontinence at least once/day
Who cannot join
- Daytime voiding frequency less than 5
- Uroflow indicative of pathology other than OAB
- Maximum voided volume > age expected capacity ([age +1] x 30) in ml
- Post voiding residual (PVR) > 10% of the functional bladder capacity
- Monosymptomatic enuresis
- Congenital anomalies of the genito-urinary tract or nervous system
Show all 10Show fewer
- Current constipation (when treated the patient can enter the study)
- Current urinary tract infection (patient will be eligible for enrolment 14 days after a negative dipstick test, provided a second dipstick test, performed after these 14 days, is also negative)
- Serum creatinine more than or equal to 2 times the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than or equal to 2 times ULN, or bilirubin more than or equal to 1.5 times ULN
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United Kingdom3 sites
Study site
Cambridge, CB2 2QQ
Study site
Manchester, M13 9WL
Study site
Sheffield, S10 2TH
About this study
Official title: A Multicenter, Open-label, Single Ascending Dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Patients Aged 5 to 17 Years (Inclusive) With Overactive Bladder (OAB)
This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder.
Read the detailed description
This is a multicenter, open-label, sequential, single ascending dose study. The study will consist of three treatment groups in children and three treatment groups in adolescents, targeting equivalent exposure to the 2.5, 5 and 10 mg doses o.d. in adults at steady state. The study will be conducted in pediatric OAB patients to establish the single-dose PK and the acute safety profile of solifenacin aqueous suspension. Each of the six groups will consist of at least six patients.
The study will start with the lowest dose group in adolescent patients (12 to 17 years). When this group has completed the study, their safety and concentration data will be reviewed by a Safety Review Committee. If no safety concerns are evident according to pre-specified criteria, enrollment of children (5 to 11 years) in the lowest dose group and adolescents in the intermediate dose group will be started simultaneously. When these groups have completed the study, their safety data and drug concentration data will also be reviewed. If no safety concerns occurred, enrollment of children in the intermediate dose group and of adolescents in the highest dose group will be started simultaneously. Finally, after these groups completed the study and no safety concerns occurred during associated data review, enrollment of children in the highest dose group will start. Interim review of plasma exposure at lower doses will be used to adjust the next higher doses administered, if necessary.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- Solifenacin succinate suspension 2.5 mg, Solifenacin succinate suspension 5 mg, Solifenacin succinate suspension 10 mg
- Keywords
- Overactive bladder, Solifenacin suspension, Pharmacokinetics, Single-dose, 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 suspension 2.5 mgDrug
Also called YM905
Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 2.5 mg of solifenacin once daily in adults.
Solifenacin succinate suspension 5 mgDrug
Also called YM905
Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 5 mg dose of solifenacin once daily in adults.
Solifenacin succinate suspension 10 mgDrug
Also called YM905
Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses 10 mg dose of solifenacin once daily in adults.
| Study group | Role | What they receive |
|---|---|---|
| AD-PED 2.5 mg | Experimental | Male and female adolescents aged 12 to less than 18 years old who receive pediatric equivalent dose (PED) of 2.5 mg of solifenacin succinate. Receives: Drug: Solifenacin succinate suspension 2.5 mg |
| AD-PED 5 mg | Experimental | Male and female adolescents aged 12 to less than 18 years old who receive PED of 5 mg of solifenacin succinate. Receives: Drug: Solifenacin succinate suspension 5 mg |
| AD-PED 10 mg | Experimental | Male and female adolescents aged 12 to less than 18 years old who receive PED of 10 mg of solifenacin succinate. Receives: Drug: Solifenacin succinate suspension 10 mg |
| CH-PED 2.5 mg | Experimental | Male and female children aged 5 to less than 12 years old who receive PED of 2.5 mg of solifenacin succinate. Receives: Drug: Solifenacin succinate suspension 2.5 mg |
| CH-PED 5 mg | Experimental | Male and female children aged 5 to less than 12 years old who receive PED of 5 mg of solifenacin succinate. Receives: Drug: Solifenacin succinate suspension 5 mg |
| CH-PED 10 mg | Experimental | Male and female children aged 5 to less than 12 years old who receive PED of 10 mg of solifenacin succinate. Receives: Drug: Solifenacin succinate suspension 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Concentration (Cmax)
Measured: Day 1 predose up to Day 7 postdose
Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf)
Measured: Day 1 predose up to Day 7 postdose
Apparent Terminal Elimination Half-life (t1/2)
Measured: Day 1 predose up to Day 7 postdose
Time to Attain Cmax (tmax)
Measured: Day 1 predose up to Day 7 postdose
Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
Measured: Day 1 predose up to Day 7 postdose
Apparent Total Body Clearance (CL/F)
Measured: Day 1 predose up to Day 7 postdose
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Measured: Day 1 predose up to Day 7 postdose
Secondary outcomes (2)
Number of Participants with Adverse Events (AEs)
Safety is monitored by collecting AEs, which includes abnormal laboratory tests, vital signs or ECG data that are defined as an AE if the abnormality induces clinical signs or symptoms, requires active intervention, interruption or discontinuation of study medication or is clinically significant in the investigator's opinion. A treatment-emergent adverse event (TEAE) is defined as an AE that occurs or worsens after study drug administration. A serious AE (SAE) is any untoward medical occurrence that, at any dose: Results in death, is life-threatening, results in persistent or significant disability/incapacity, results in congenital anomaly, or birth defect, requires inpatient hospitalization or leads to prolongation of hospitalization or other medically important events.
Measured: From the first dose of study drug up to 7 days postdose
Change from baseline in postvoid residual (PVR) volume
PVR volume is assessed by ultrasonography or bladder scan.
Measured: Baseline (screening) and 4 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study start20 Oct 2010
- Primary completion14 Aug 2011
- Study completion14 Aug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study chair, Astellas Pharma Europe B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262391
- Sponsor's protocol ID
- 905-CL-075
- Other IDs
- 2009-017197-21, 2009
- Status last verified
- Oct 2024
- First submitted
- 1 Nov 2010
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Access to anonymized individual participant level data will not be provided for this trial. 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Single Ascending Dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Patients Aged 5 to 17 Years (Inclusive) With Overactive Bladder (OAB)
- ClinicalTrials.gov ID
- NCT01262391
- Acronym / sponsor ID
- 905-CL-075
- Conditions
- Urinary Bladder, Overactive
- Keywords
- Overactive bladder, Solifenacin suspension, Pharmacokinetics, Single-dose, Pediatric
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2010 (actual)
- Primary completion
- 14 Aug 2011 (actual)
- Study completion
- 14 Aug 2011 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-dose study will investigate how well solifenacin suspension is taken up, how long it stays in the body and how well it will be tolerated in children and adolescents aged 5-17 years with symptoms of overactive bladder.
Detailed description
This is a multicenter, open-label, sequential, single ascending dose study. The study will consist of three treatment groups in children and three treatment groups in adolescents, targeting equivalent exposure to the 2.5, 5 and 10 mg doses o.d. in adults at steady state. The study will be conducted in pediatric OAB patients to establish the single-dose PK and the acute safety profile of solifenacin aqueous suspension. Each of the six groups will consist of at least six patients.
The study will start with the lowest dose group in adolescent patients (12 to 17 years). When this group has completed the study, their safety and concentration data will be reviewed by a Safety Review Committee. If no safety concerns are evident according to pre-specified criteria, enrollment of children (5 to 11 years) in the lowest dose group and adolescents in the intermediate dose group will be started simultaneously. When these groups have completed the study, their safety data and drug concentration data will also be reviewed. If no safety concerns occurred, enrollment of children in the intermediate dose group and of adolescents in the highest dose group will be started simultaneously. Finally, after these groups completed the study and no safety concerns occurred during associated data review, enrollment of children in the highest dose group will start. Interim review of plasma exposure at lower doses will be used to adjust the next higher doses administered, if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| AD-PED 2.5 mg | Experimental | Drug: Solifenacin succinate suspension 2.5 mgMale and female adolescents aged 12 to less than 18 years old who receive pediatric equivalent dose (PED) of 2.5 mg of solifenacin succinate. |
| AD-PED 5 mg | Experimental | Drug: Solifenacin succinate suspension 5 mgMale and female adolescents aged 12 to less than 18 years old who receive PED of 5 mg of solifenacin succinate. |
| AD-PED 10 mg | Experimental | Drug: Solifenacin succinate suspension 10 mgMale and female adolescents aged 12 to less than 18 years old who receive PED of 10 mg of solifenacin succinate. |
| CH-PED 2.5 mg | Experimental | Drug: Solifenacin succinate suspension 2.5 mgMale and female children aged 5 to less than 12 years old who receive PED of 2.5 mg of solifenacin succinate. |
| CH-PED 5 mg | Experimental | Drug: Solifenacin succinate suspension 5 mgMale and female children aged 5 to less than 12 years old who receive PED of 5 mg of solifenacin succinate. |
| CH-PED 10 mg | Experimental | Drug: Solifenacin succinate suspension 10 mgMale and female children aged 5 to less than 12 years old who receive PED of 10 mg of solifenacin succinate. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Symptoms of urgency, diagnosed as OAB according to International Children's Continence Society (ICCS) criteria
- Daytime urgency incontinence at least once/day
Key exclusion criteria (10 listed)
- Daytime voiding frequency less than 5
- Uroflow indicative of pathology other than OAB
- Maximum voided volume > age expected capacity ([age +1] x 30) in ml
- Post voiding residual (PVR) > 10% of the functional bladder capacity
- Monosymptomatic enuresis
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 suspension 2.5 mgAlso: YM905Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 2.5 mg of solifenacin once daily in adults. | Drug | AD-PED 2.5 mg, CH-PED 2.5 mg |
| Solifenacin succinate suspension 5 mgAlso: YM905Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 5 mg dose of solifenacin once daily in adults. | Drug | AD-PED 5 mg, CH-PED 5 mg |
| Solifenacin succinate suspension 10 mgAlso: YM905Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses 10 mg dose of solifenacin once daily in adults. | Drug | AD-PED 10 mg, CH-PED 10 mg |
Primary outcome
Maximum Concentration (Cmax)
Time frame: Day 1 predose up to Day 7 postdose
Area Under the Concentration-time Curve Extrapolated to Infinity (AUCinf)
Time frame: Day 1 predose up to Day 7 postdose
Apparent Terminal Elimination Half-life (t1/2)
Time frame: Day 1 predose up to Day 7 postdose
Time to Attain Cmax (tmax)
Time frame: Day 1 predose up to Day 7 postdose
Area Under the Concentration-time Curve from the Time of Dosing Until the Last Measurable Concentration (AUClast)
Time frame: Day 1 predose up to Day 7 postdose
Apparent Total Body Clearance (CL/F)
Time frame: Day 1 predose up to Day 7 postdose
Apparent Volume of Distribution During the Terminal Phase (Vz/F)
Time frame: Day 1 predose up to Day 7 postdose
2 secondary outcomes
Number of Participants with Adverse Events (AEs)
Time frame: From the first dose of study drug up to 7 days postdose
Change from baseline in postvoid residual (PVR) volume
Time frame: Baseline (screening) and 4 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Individual participant dataSharing planned: No. Access to anonymized individual participant level data will not be provided for this trial. 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.
Use Central Contact study chair
Astellas Pharma Europe B.V.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Solifenacin succinate suspension 2.5 mg, Solifenacin succinate suspension 5 mg and Solifenacin succinate suspension 10 mg in people with Urinary Bladder, Overactive, run by Astellas Pharma Inc at 8 sites in 4 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 2 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 22 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 8 sites in United Kingdom, Belgium, Sweden, Denmark. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum Concentration (Cmax) (time frame: Day 1 predose up to Day 7 postdose). The study lists 7 primary outcomes in all. 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 22 Oct 2024.