Overactive BladderPhase 2NCT00857896
Study Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years
A Phase 2 study testing Fesoterodine in people with Overactive Bladder and Neurogenic Detrusor Overactivity, run by Pfizer at 9 sites in United States.
Trial summary
The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Overactive Bladder, Neurogenic Detrusor Overactivity
- What is being tested?
- Fesoterodine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2009to Dec 2010
- Phase
- Phase 2
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A total body weight >25 kg (55 lbs).
- Symptoms of urinary frequency (average ≥8 daily bathroom visits to urinate) and urgency to urinate, with or without urgency incontinence, for at least 6 months prior to enrolment, OR
- Stable neurological disease and urodynamically confirmed detrusor overactivity, who may require intermittent catheterization for management of urinary drainage.
Who cannot join
- Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, before first study dose
- Ongoing use of potent CYP3A4 inhibitors or inducers or CYP2D6 inhibitors
- Ongoing use of another drug for treating overactive bladder
- Uncontrolled narrow angle glaucoma, urinary or gastric retention
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Pfizer Investigational Site
Cincinnati, Ohio, 45229
Pfizer Investigational Site
Cleveland, Ohio, 44106
Pfizer Investigational Site
Liberty Township, Ohio, 45044
Pfizer Investigational Site
Little Rock, Arkansas, 72204
Pfizer Investigational Site
Long Beach, California, 90806
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Overland Park, Kansas, 66212
Pfizer Investigational Site
Shreveport, Louisiana, 71106-8150
Pfizer Investigational Site
Troy, Michigan, 48084
About this study
Official title: An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years.
The purpose of the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder.
- Being tested
- Fesoterodine
- Keywords
- Study of fesoterodine in pediatric overactive bladder patients
- 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.
FesoterodineDrug
4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8
| Study group | Role | What they receive |
|---|---|---|
| Fesoterodine once daily | Experimental | Not described Receives: Drug: Fesoterodine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorption Rate Constant (Ka)
Measured: Day 28 and Day 56
Apparent Volume of Distribution (VC/F)
The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling.
Measured: Day 28 and Day 56
Area Under the Plasma Drug Concentration Time Curve (AUC)
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Measured: Day 28 and Day 56
Maximum Observed Plasma Concentration (Cmax)
Measured: Day 28 and Day 56
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: Day 28 and Day 56
Plasma Decay Half-Life (t1/2)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Measured: Day 28 and Day 56
Apparent Oral Clearance (CL/F)
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Measured: Day 28 and Day 56
Secondary outcomes (1)
Post-void Residual (PVR) Volume
Volume of urine remaining in the bladder immediately after urination.
Measured: Baseline, Week 4, and Week 8 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionDec 2010
- Study completionDec 2010
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 (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857896
- Sponsor's protocol ID
- A0221066
- Status last verified
- Nov 2011
- First submitted
- 26 Feb 2009
- Last updated
- 24 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sano Y, Shoji S, Shahin M, Sweeney K, Darekar A, Malhotra BK. Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity. Eur J Drug Metab Pharmacokinet. 2023 May;48(3):257-269. doi: 10.1007/s13318-023-00818-8. Epub 2023 Mar 9.
PubMed 36892754
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalating Study Of The Pharmacokinetics, Safety And Tolerability Of Fesoterodine In Pediatric Overactive Bladder Patients Aged 8-17 Years.
- ClinicalTrials.gov ID
- NCT00857896
- Acronym / sponsor ID
- A0221066
- Keywords
- Study of fesoterodine in pediatric overactive bladder patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Posted 17 Nov 2011
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 the study is to evaluate the pharmacokinetics, safety, and tolerability of fesoterodine following administration to pediatric patients, aged 8-17 years, with overactive bladder.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fesoterodine once daily | Experimental | Drug: Fesoterodine |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- A total body weight >25 kg (55 lbs).
- Symptoms of urinary frequency (average ≥8 daily bathroom visits to urinate) and urgency to urinate, with or without urgency incontinence, for at least 6 months prior to enrolment, OR
- Stable neurological disease and urodynamically confirmed detrusor overactivity, who may require intermittent catheterization for management of urinary drainage.
Key exclusion criteria (4 listed)
- Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, before first study dose
- Ongoing use of potent CYP3A4 inhibitors or inducers or CYP2D6 inhibitors
- Ongoing use of another drug for treating overactive bladder
- Uncontrolled narrow angle glaucoma, urinary or 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 |
|---|---|---|
| Fesoterodine4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8 | Drug | Fesoterodine once daily |
Primary outcome
Absorption Rate Constant (Ka)
Time frame: Day 28 and Day 56
Apparent Volume of Distribution (VC/F)
Time frame: Day 28 and Day 56
The volume necessary to account for the total amount of drug in the body if it were present throughout the body at the same concentration found in the blood. Estimated using non linear mixed effect modeling.
Area Under the Plasma Drug Concentration Time Curve (AUC)
Time frame: Day 28 and Day 56
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)
Time frame: Day 28 and Day 56
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Day 28 and Day 56
Plasma Decay Half-Life (t1/2)
Time frame: Day 28 and Day 56
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Apparent Oral Clearance (CL/F)
Time frame: Day 28 and Day 56
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated using non linear mixed effect modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
1 secondary outcome
Post-void Residual (PVR) Volume
Time frame: Baseline, Week 4, and Week 8 post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36892754Sano Y, Shoji S, Shahin M, Sweeney K, Darekar A, Malhotra BK. Population Pharmacokinetic and Pharmacodynamic Modeling of Fesoterodine in Pediatric Patients with Neurogenic Detrusor Overactivity. Eur J Drug Metab Pharmacokinet. 2023 May;48(3):257-269. doi: 10.1007/s13318-023-00818-8. Epub 2023 Mar 9.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Overactive Bladder
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
Active, not recruitingPhase 2/3
Examining the Effects of Intra-detrusor Botox at Time of HoLEP in Men With Overactive Bladder Symptoms
Urinary Incontinence, Overactive Bladder Syndrome
Recruiting
UCon Treatment of Overactive Bladder (OAB) in Males
Urinary Incontinence, Urge Incontinence
Active, not recruitingObservational study
Overactive Bladder Symptoms and Urinary Incontinence In Women With Rheumatoid Arthritis
Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
RecruitingObservational study
Predictive Value of Inflammatory Biomarkers for Mirabegron Response in Women With Overactive Bladder
Overactive Bladder (OAB)
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.
Pfizer CT.gov Call Center study director
Pfizer
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fesoterodine in people with Overactive Bladder and Neurogenic Detrusor Overactivity, run by Pfizer at 9 sites in United States.
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 4 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 24 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 17 Nov 2011). 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?
Absorption Rate Constant (Ka) (time frame: Day 28 and Day 56). 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?
On the ClinicalTrials.gov record for NCT00857896, which also lists 1 linked publication.
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 24 Nov 2011.