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Toviaz Post Marketing Surveil...

Toviaz Post Marketing Surveillance Study

Last Updated: 2015-10-21

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2014-08-31

Brief Summary

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The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.

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Detailed Description

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continuous registration method

Conditions

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Overactive Bladder

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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OAB-Toviaz

All patients who enrolled in this study

Toviaz treatment

Intervention Type DRUG

4 mg starting then can be followed by 8 mg

Interventions

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Toviaz treatment

4 mg starting then can be followed by 8 mg

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Soo Urology Clinic

Asan, Chungcheongnam-do, South Korea

Site Status

Seo Kyung-Keun Urology Clinic

Cheonan-si, Chungcheongnam-do, South Korea

Site Status

Cheonan Medical Center

Cheonan-Si, Chungcheongnam-do, South Korea

Site Status

Seoul Urology Clinic

Gongju, Chungcheongnam-do, South Korea

Site Status

Lee Urology Clinic

Gongju, Chungcheongnam-do, South Korea

Site Status

Moa gynecology

Nonsan, Chungcheongnam-do, South Korea

Site Status

Song In-Ho Urology Clinic

Tangjin, Chungcheongnam-do, South Korea

Site Status

Jung Woong Gyo Urology Clinic

Wŏnju, Gangwon-do, South Korea

Site Status

Ansan Themapark Medical Center

Ansan, Gyeonggi-do, South Korea

Site Status

Woosung Yusung Hospital

Ansan, Gyeonggi-do, South Korea

Site Status

Kim Tae Joon Internal Medicine

Ansan-si, Gyeonggi-do, South Korea

Site Status

Yoo And Lee Dematology Urology Clinic

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Myung Urology Hospital

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Gimpo Woori Hospital

Gimpsi, Gyeonggi-do, South Korea

Site Status

Samsung Clinic

Goyang-si, Gyeonggi-do, South Korea

Site Status

Hwang Family Medicine Clinic

Goyang-si, Gyeonggi-do, South Korea

Site Status

Lee Urology Clinic

Namyangju, Gyeonggi-do, South Korea

Site Status

Park Dermatology And Urology Clinic

Pyeongtaek-si, Gyeonggi-do, South Korea

Site Status