Drug Use Investigation for Toviaz

Overactive Bladder (OAB) Clinical Trial

Official title:

DRUG USE INVESTIGATION FOR TOVIAZ

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936870
• Other study ID #: A0221096
• Status: Completed
• Start date: October 1, 2013
• Est. completion date: May 19, 2016

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2521
• Est. completion date: May 19, 2016
• Est. primary completion date: May 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients prescribed fesoterodine (Toviaz).

Exclusion Criteria:

• There are no exclustion criteria

Related Conditions & MeSH terms

• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Intervention

Drug:
• Fesoterodine (Toviaz)
Fesoterodine 4 mg or 8 mg orally. Toviaz will be dosed according to labeling. The administration and duration of therapy will be determined by the treating physician to meet the patient's needs for treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Related Adverse Events	A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.	12 Weeks
Primary	Clinical Efficacy Rate	Clinical efficacy rate, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Overall effectiveness of fesoterodine fumarate was determined by the investigator based on clinical symptoms and examinations. Clinical effectiveness was assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable at week 12 of the treatment.	12 Weeks
Secondary	Number of Participants With Treatment-Related Serious Adverse Events	A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to fesoterodine fumarate was assessed by the investigator.	12 Weeks
Secondary	Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert	A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Expectedness of the adverse event was determined according to the Japanese package insert. Relatedness to fesoterodine fumarate was assessed by the investigator.	12 Weeks
Secondary	Number of Participants With Adverse Events Related to Cognitive Function Disorder	An adverse event was any untoward medical occurrence in a participant who received fesoterodine fumarate without regard to possibility of causal relationship. Adverse events related to cognitive function disorder were identified by broad searches on the Standard MedDRA Queries (SMQ).	12 Weeks
Secondary	Change From Baseline in the Mini-Mental State Examination (MMSE) Score at 12 Weeks	Mini-Mental State Examination (MMSE) measured general cognitive functioning: orientation, memory, attention, concentration, naming, repetition, comprehension, and ability to create a sentence and to copy two intersecting polygons. Total score derived from sub-scores; total ranged from 0 to 30, higher score indicates better cognitive state. Mean change from baseline in the MMSE score at 12 weeks was presented along with the corresponding standard deviation.	Baseline, 12 Weeks
Secondary	Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 Inhibitors	Cytochrome P450 3A4 (CYP3A4) inhibitors included atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, ritonavir, saquinavir, and telithromycin.	12 Weeks
Secondary	Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP2D6 Inhibitors	Cytochrome P450 2D6 (CYP2D6) inhibitors included quinidine and paroxetine. A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.	12 Weeks
Secondary	Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg	A treatment-related adverse event was any untoward medical occurrence attributed to fesoterodine fumarate in a participant who received fesoterodine fumarate. Relatedness to fesoterodine fumarate was assessed by the investigator.	12 Weeks
Secondary	Satisfaction Rate	Satisfaction rate, which was defined as the percentage of participants who were satisfied by fesoterodine fumarate treatment over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Satisfaction scale was assessed by the participants according to the following categories: (1) satisfied, (2) unsatisfied, (3) uncertain, or (4) unconfirmed.	12 Weeks
Secondary	Change From Baseline in the Overactive Bladder Symptom Score (OABSS) at 12 Weeks	Overactive Bladder Symptom Score (OABSS) was defined as the sum score (0 to 15) of the following four OAB symptoms: daytime frequency (2 at maximum), nighttime frequency (3 at maximum), urgency (5 at maximum), and urgency incontinence (5 at maximum). Higher score indicates worse symptoms. Mean change from baseline in the OABSS at 12 weeks was presented along with the corresponding standard deviation.	Baseline, 12 Weeks

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