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Toviaz Post Marketing Surveillance Study

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NCT00879398

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Hankook General Hospital
Cheongju-si, Chungcheongbuk-do, 360-090 Korea, Republic of
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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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Toviaz Post Marketing Surveillance Study
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Toviaz (Registered)
The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.
continuous registration method
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
- 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.
Overactive Bladder
Drug: Toviaz treatment
4 mg starting then can be followed by 8 mg
OAB-Toviaz
All patients who enrolled in this study
Intervention: Drug: Toviaz treatment
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3000
August 2014
August 2014   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00879398
A0221075
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2015

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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