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Adult Trials: 18+ Years
- 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.
- 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)
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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 | 3000 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | September 2015 | |||