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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fesoterodine once daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fesoterodine | Drug | 4 mg once daily for Weeks 1-4 and 8 mg once daily for Weeks 5-8 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absorption Rate Constant (Ka) | 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. | 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. | Day 28 and Day 56 |
| Maximum Observed Plasma Concentration (Cmax) | Day 28 and Day 56 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | 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. | 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. | Day 28 and Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-void Residual (PVR) Volume | Volume of urine remaining in the bladder immediately after urination. | Baseline, Week 4, and Week 8 post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Little Rock | Arkansas | 72204 | United States | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36892754 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fesoterodine | Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to Week 4 |
|
| ||||||||||||||||||
| Week 5 to Week 8 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fesoterodine | Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Absorption Rate Constant (Ka) | Pharmacokinetic (PK) concentration population: randomized and treated participants who had at least 1 concentration during the study. | Posted | Mean | 95% Confidence Interval | 1/hour (hr) | Day 28 and Day 56 |
|
|
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The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fesoterodine 4 mg | Fesoterodine 4 mg tablet QD anytime during the study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA v13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hip dysplasia | Congenital, familial and genetic disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C526675 | fesoterodine |
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| Long Beach |
| California |
| 90806 |
| United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66211 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Shreveport | Louisiana | 71106-8150 | United States |
| Pfizer Investigational Site | Troy | Michigan | 48084 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45229 | United States |
| Pfizer Investigational Site | Cleveland | Ohio | 44106 | United States |
| Pfizer Investigational Site | Liberty Township | Ohio | 45044 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Primary | 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. | PK Concentration | Posted | Mean | 95% Confidence Interval | Liters (L) | Day 28 and Day 56 |
|
|
|
| Primary | 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. | Not analyzed due to the limited amount of data available. | Posted | Mean | Standard Deviation | mcg*h/mL | Day 28 and Day 56 |
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) | Not analyzed due to the limited amount of data available. | Posted | Mean | Standard Deviation | micrograms per milliliter (mcg/mL) | Day 28 and Day 56 |
|
|
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) | Not analyzed due to the limited amount of data available. | Posted | Mean | Standard Deviation | hours | Day 28 and Day 56 |
|
|
| Primary | Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Not analyzed due to the limited amount of data available. | Posted | Mean | Standard Deviation | hours | Day 28 and Day 56 |
|
|
| Primary | 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. | PK Concentration | Posted | Mean | 95% Confidence Interval | L/hr | Day 28 and Day 56 |
|
|
|
| Secondary | Post-void Residual (PVR) Volume | Volume of urine remaining in the bladder immediately after urination. | Safety Population: all participants who were known to have received study medication; Number of participants analyzed (N) = participants not performing clean intermittent bladder catheterization (CIC); n = participants not performing CIC at specified time point. | Posted | Median | Full Range | mL | Baseline, Week 4, and Week 8 post-dose |
|
|
|
| 0 |
| 21 |
| 8 |
| 21 |
| EG001 | Fesoterodine 8 mg | Fesoterodine 8 mg tablet QD anytime during the study | 1 | 20 | 13 | 20 |
| Dry eye | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Joint abscess | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Residual urine volume increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|