Overactive BladderPhase 1NCT01539707
Single Dose Study to Measure Blood Levels and Safety of a Drug for Children With Overactive Bladder
A Phase 1 study testing Solifenacin succinate suspension 5 mg in people with Overactive Bladder and Neurogenic Detrusor Overactivity, run by Astellas Pharma Inc at 7 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after taking a single oral dose. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Overactive Bladder, Neurogenic Detrusor Overactivity
- What is being tested?
- Solifenacin succinate suspension 5 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
- 14 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 13 Mar 2012to 13 Aug 2012
- 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
- Documented diagnosis of NDO, confirmed by urodynamics
- Weight and height are within normal percentiles (3rd to 97th percentile) according to Centers for Disease Control and Prevention (CDC) growth charts
- Subject's bowel function is being actively managed
- Able to swallow the study medication in accordance to the protocol
- Female subjects of childbearing potential and sexually active agree to use a reliable form of birth control for the duration of the study and for at least one month after ending study treatment. Sexually active male subjects agree to use a barrier method of birth control for the duration of the study and for at least one month after ending study treatment
- Subject and subject's parent(s)/legal guardian are willing and able to comply with the study requirements and with the concomitant medication restrictions
Who cannot join
- At screening:
- Subject is breastfeeding or pregnant. Subjects of childbearing potential must have a negative serum pregnancy test
- Subject with any of the following gastrointestinal (GI)conditions: partial or complete bowel obstruction, decreased motility (e.g., paralytic ileus) or at risk for gastric retention
- Current fecal impaction or history of hospitalization for fecal impaction with enema in the past 2 years
- History of QTc prolongation or risk of QT prolongation (e.g., hypokalemia, family history of Long QT Syndrome [LQTS]). QT interval greater than 470 ms at baseline
- Any clinically significant abnormality on ECG
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- History or current diagnosis of any malignancy
- Diagnosis of central or X chromosome-linked diabetes insipidus
- Cystatine C is greater than or equal to 2 times the upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is greater than or equal to 2 times the ULN or total bilirubin greater than or equal to 1.5 times the ULN
- Any other clinically significant out of range results of urinalysis, biochemistry or hematology
- Known or suspected hypersensitivity to solifenacin (or other anticholinergics), any of the excipients used in the current formulation or previous severe hypersensitivity to any drug
- Subject has participated in another clinical trial and/or has taken an investigational drug within 30 days (or 5 half-lives of the drug whichever is longer) prior to Day 1
- Requires ongoing treatment with any of the following prohibited medications: antimuscarinic therapy, tricyclic/tetracyclic antidepressants, H1 antihistamines, strong CYP3A4 inhibitors, strong CYP3A4 inducers (many antiepileptic drugs like carbamazepine, phenytoin and phenobarbital)
- Mean systolic blood pressure greater than the 95th percentile according to age and height and/or greater than 140 mmHg [National Institute of Health, 2005], judged as clinically significant by the investigator
- Subject's parent(s)/legal guardian is an employee of the Astellas Group, the Contract Research Organization (CRO) involved, or the investigator site executing the study
- At Day 1:
- Consumption of grapefruit and products made of it (e.g., juice), and Seville oranges and products made of it (e.g., marmalade) within 14 days prior to Day 1
- Positive drug screen test for drugs of abuse at Day 1
- Positive alcohol breath test at Day 1
- Use of prohibited prior and concomitant medication:
- Antimuscarinics, tricyclic/tetracyclic antidepressants, H1
- antihistamines within 5 half-lives prior to intake of study drug at Day 1
- Prescribed or over the counter (OTC) drugs that are potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., ketoconazole), CYP3A4 substrates with higher affinity (e.g., verapamil, diltiazem), or potent CYP3A4 inducers (e.g., rifampicin, phenytoin, carbamazepine), including natural and herbal remedies (e.g., St. John's Wort) within 14 days prior to intake of study drug at Day 1
- Donation of blood or blood products within 3 months prior to Day 1.
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
About this study
Official title: A Multicenter, Open-label, Single-dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)
The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If the bladder contracts strongly and without warning, the muscles surrounding the urethra (detrusor muscles) may not be able to keep urine from passing. This may happen as a consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.
- Being tested
- Solifenacin succinate suspension 5 mg
- Keywords
- Solifenacin succinate suspension, Pharmacokinetics, Phase 1, Neurogenic Detrusor Overactivity
- 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 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 dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).
| Study group | Role | What they receive |
|---|---|---|
| AD-PED 5 mg | Experimental | Male and female adolescents aged 12 to less than 18 years old who receive pediatric equivalent dose (PED) of 5 mg of solifenacin succinate. Receives: Drug: Solifenacin succinate suspension 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 |
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
Time to Attain Cmax (tmax)
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
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
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
Secondary outcomes (1)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2012 (estimated)
- Study start13 Mar 2012
- Primary completion13 Aug 2012
- Study completion13 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- 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
- NCT01539707
- Sponsor's protocol ID
- 905-CL-079
- Other IDs
- 2011-000250-28
- Status last verified
- Oct 2024
- First submitted
- 7 Feb 2012
- 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-dose Study to Evaluate Pharmacokinetics, Safety and Tolerability of Solifenacin Succinate Suspension in Pediatric Subjects From 5 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity (NDO)
- ClinicalTrials.gov ID
- NCT01539707
- Acronym / sponsor ID
- 905-CL-079
- Keywords
- Solifenacin succinate suspension, Pharmacokinetics, Phase 1, Neurogenic Detrusor Overactivity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Study start
- 13 Mar 2012 (actual)
- Primary completion
- 13 Aug 2012 (actual)
- Study completion
- 13 Aug 2012 (actual)
- First posted
- 27 Feb 2012 (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.
The purpose of this study is to evaluate blood levels of solifenacin succinate (the study drug) in children with neurogenic detrusor overactivity after taking a single oral dose. If the bladder contracts strongly and without warning, the muscles surrounding the urethra (detrusor muscles) may not be able to keep urine from passing. This may happen as a consequence of spinal cord defects, and then is called neurogenic detrusor overactivity.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD-PED 5 mg | Experimental | Drug: Solifenacin succinate suspension 5 mgMale and female adolescents aged 12 to less than 18 years old who receive pediatric equivalent dose (PED) of 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. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Documented diagnosis of NDO, confirmed by urodynamics
- Weight and height are within normal percentiles (3rd to 97th percentile) according to Centers for Disease Control and Prevention (CDC) growth charts
- Subject's bowel function is being actively managed
- Able to swallow the study medication in accordance to the protocol
- Female subjects of childbearing potential and sexually active agree to use a reliable form of birth control for the duration of the study and for at least one month after ending study treatment. Sexually active male subjects agree to use a barrier method of birth control for the duration of the study and for at least one month after ending study treatment
Key exclusion criteria (25 listed)
- Subject is breastfeeding or pregnant. Subjects of childbearing potential must have a negative serum pregnancy test
- Subject with any of the following gastrointestinal (GI)conditions: partial or complete bowel obstruction, decreased motility (e.g., paralytic ileus) or at risk for gastric retention
- Current fecal impaction or history of hospitalization for fecal impaction with enema in the past 2 years
- History of QTc prolongation or risk of QT prolongation (e.g., hypokalemia, family history of Long QT Syndrome [LQTS]). QT interval greater than 470 ms at baseline
- Any clinically significant abnormality on ECG
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 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 dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg). | Drug | AD-PED 5 mg, CH-PED 5 mg |
Primary outcome
Maximum concentration (Cmax)
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 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
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
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
1 secondary outcome
Number of Participants with Adverse Events (AEs)
Time frame: From the first dose of study drug up to 7 days 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.
Clinical Study Manager study chair
Astellas Pharma Europe B.V.
7 sites in 7 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 5 mg in people with Overactive Bladder and Neurogenic Detrusor Overactivity, run by Astellas Pharma Inc at 7 sites in 7 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 6 inclusion and 25 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 7 sites in Belgium, Canada, Denmark, Netherlands, Poland and 2 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 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.