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Toviaz Post Marketing Surveillance Study

Last updated on November 16, 2019

FOR MORE INFORMATION
Study Location
Hankook General Hospital
Cheongju-si, Chungcheongbuk-do, 360-090 Korea, Republic of
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Subjects who are diagnosed as Overactive Bladder (OAB) defined as urgency, with or
without urgency incontinence, usually with frequency and nocturia, in the absence of
local or metabolic factors explaining these factors.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Hypersensitivity to the active substance or to peanut or soya or any of the
excipients

- Urinary retention

- Gastric retention

- Uncontrolled narrow angle glaucoma

- Myasthenia gravis

- Severe hepatic impairment (Child Pugh C)

- Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe
hepatic or renal impairment

- Severe ulcerative colitis

- Toxic megacolon

- Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption (Toviaz® prolonged-release tablets
contain lactose)

NCT00879398
Pfizer
Completed
Toviaz Post Marketing Surveillance Study

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Descriptive Information
Brief TitleToviaz Post Marketing Surveillance Study
Official TitlePost Marketing Surveillance Study To Observe Safety And Efficacy Of Toviaz (Registered)
Brief SummaryThe objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.
Detailed Descriptioncontinuous registration method
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Population- Subjects who are diagnosed as Overactive Bladder (OAB) defined as urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of local or metabolic factors explaining these factors.
ConditionOveractive Bladder
InterventionDrug: Toviaz treatment
4 mg starting then can be followed by 8 mg
Study Groups/CohortsOAB-Toviaz
All patients who enrolled in this study
Intervention: Drug: Toviaz treatment
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 StatusCompleted
Actual Enrollment
 (submitted: July 28, 2015)
3000
Original Estimated Enrollment
 (submitted: April 9, 2009)
4500
Actual Study Completion DateAugust 2014
Actual Primary Completion DateAugust 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects who are diagnosed as Overactive Bladder (OAB) defined as urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of local or metabolic factors explaining these factors.

Exclusion Criteria:

  • Hypersensitivity to the active substance or to peanut or soya or any of the excipients
  • Urinary retention
  • Gastric retention
  • Uncontrolled narrow angle glaucoma
  • Myasthenia gravis
  • Severe hepatic impairment (Child Pugh C)
  • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
  • Severe ulcerative colitis
  • Toxic megacolon
  • Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Toviaz® prolonged-release tablets contain lactose)
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00879398
Other Study ID NumbersA0221075
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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