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Toviaz Post Marketing Surveillance Study

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NCT00879398

Last updated on February 18, 2020
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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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Descriptive Information
Brief Title Toviaz Post Marketing Surveillance Study
Official Title Post Marketing Surveillance Study To Observe Safety And Efficacy Of Toviaz (Registered)
Brief Summary The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.
Detailed Description continuous registration method
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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.
Condition Overactive Bladder
Intervention Drug: Toviaz treatment
4 mg starting then can be followed by 8 mg
Study Groups/Cohorts OAB-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 Status Completed
Actual Enrollment
 (submitted: July 28, 2015) 		3000
Original Estimated Enrollment
 (submitted: April 9, 2009) 		4500
Actual Study Completion Date August 2014
Actual Primary Completion Date August 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
Ages 18 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 Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT00879398
Other Study ID Numbers A0221075
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 September 2015

FOR MORE INFORMATION

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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