Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01936870
Previous Study | Return to List | Next Study

Drug Use Investigation for Toviaz

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01936870
Recruitment Status : Completed
First Posted : September 6, 2013
Results First Posted : April 7, 2017
Last Update Posted : April 7, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date September 3, 2013
First Posted Date September 6, 2013
Results First Submitted Date February 22, 2017
Results First Posted Date April 7, 2017
Last Update Posted Date April 7, 2017
Study Start Date October 2013
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 22, 2017)
  • Number of Participants With Treatment-Related Adverse Events [ Time Frame: 12 Week ]
    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.
  • Clinical Efficacy Rate [ Time Frame: 12 Weeks ]
    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.
Original Primary Outcome Measures
 (submitted: September 3, 2013)
Number of Participants with Change from Baseline in Clinical Global Impression of Clinical Condition (CGI-C) [ Time Frame: 12 weeks ]
The CGI-C scale measures a physician's global impression of a participant's clinical condition at final visit in terms of change relative to the start of treatment (CGI-C). At final visit, the participants CGI-C will be categorized into a three point scale as: improvement: CGI response of very much improved, much improved or minimally improved; no change: CGI response of no change; worsening: CGI response of very much worse, much worse or minimally worse
Change History
Current Secondary Outcome Measures
 (submitted: February 22, 2017)
  • Number of Participants With Treatment-Related Serious Adverse Events [ Time Frame: 12 Week ]
    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.
  • Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert [ Time Frame: 12 Week ]
    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.
  • Number of Participants With Adverse Events Related to Cognitive Function Disorder [ Time Frame: 12 Weeks ]
    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).
  • Change From Baseline in the Mini-Mental State Examination (MMSE) Score [ Time Frame: Baseline, 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.
  • Number of Participants With Treatment-Related Adverse Events Among Whom Received Concomitant CYP3A4 or CYP2D6 Inhibitors [ Time Frame: 12 Weeks ]
    Cytochrome P450 3A4 (CYP3A4) inhibitors included atazanavir, clarithromycin, indinavir, itraconazole, nelfinavir, ritonavir, saquinavir, and telithromycin. 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.
  • Number of Participants With Treatment-Related Adverse Events Among Whose Dose Was Increased From 4 mg to 8 mg [ Time Frame: 12 Weeks ]
    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.
  • Satisfaction Rate [ Time Frame: 12 Weeks ]
    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.
  • Change From Baseline in the Overactive Bladder Symptom Score (OABSS) [ Time Frame: Baseline, 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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Drug Use Investigation for Toviaz
Official Title Drug Use Investigation For Toviaz
Brief Summary The purpose of this study is to collect effectiveness and safety information of fesoterodine related to their appropriate use in daily practice.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients prescribed fesoterodine (Toviaz) by investigators involved in protocol A0221096.
Condition Overactive Bladder (OAB)
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.
Study Groups/Cohorts Fesoterodine (Toviaz)
Intervention: Drug: Fesoterodine (Toviaz)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 10, 2016)
2521
Original Estimated Enrollment
 (submitted: September 3, 2013)
2000
Actual Study Completion Date May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients prescribed fesoterodine (Toviaz).

Exclusion Criteria:

  • There are no exclustion criteria
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01936870
Other Study ID Numbers A0221096
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2017