Toviaz Post Marketing Surveillance Study
This study is enrolling participants by invitation only.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00879398
First received: April 9, 2009
Last updated: May 1, 2013
Last verified: May 2013
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Purpose
The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.
| Condition | Intervention | Phase |
|---|---|---|
|
Overactive Bladder |
Drug: Toviaz treatment |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Post Marketing Surveillance Study To Observe Safety And Efficacy Of Toviaz®. |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Endpoint on final efficacy: Clinical response at post-therapy (micturition behavior-frequency, urgency, urgency urinary incontinence) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Endpoint on final safety: Incidence of adverse event categorized according to physical organ and disease/ symptom; others, abnormal finding from laboratory test (if any) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Bladder diary variables (optional): Sub- analysis could be done by factors which are considered to affect efficacy. These factors include patient's status at baseline, age, sex, medical history, etc. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 4500 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
OAB-Toviaz
All patients who enrolled in this study
|
Drug: Toviaz treatment
4 mg starting then can be followed by 8 mg
|
Detailed Description:
continuous registration method
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| 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.
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)
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00879398 History of Changes |
| Other Study ID Numbers: | A0221075 |
| Study First Received: | April 9, 2009 |
| Last Updated: | May 1, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Urological Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013