Status:
COMPLETED
Toviaz Post Marketing Surveillance Study
Lead Sponsor:
Pfizer
Conditions:
Overactive Bladder
Eligibility:
All Genders
18+ years
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
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
3000 Patients enrolled
Trial Details
Trial ID
NCT00879398
Start Date
November 1 2009
End Date
August 1 2014
Last Update
October 21 2015
Active Locations (82)
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1
Soo Urology Clinic
Asan, Chungcheongnam-do, South Korea, 336-010
2
Seo Kyung-Keun Urology Clinic
Cheonan-si, Chungcheongnam-do, South Korea, 330-730
3
Cheonan Medical Center
Cheonan-Si, Chungcheongnam-do, South Korea, 330-930
4
Seoul Urology Clinic
Gongju, Chungcheongnam-do, South Korea, 314-030