Toviaz Post Marketing Surveillance Study
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00879398 |
|
Recruitment Status :
Completed
First Posted : April 10, 2009
Results First Posted : September 4, 2015
Last Update Posted : October 21, 2015
|
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Overactive Bladder | Drug: Toviaz treatment |
| Study Type : | Observational |
| Actual Enrollment : | 3000 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Prospective |
| Official Title: | Post Marketing Surveillance Study To Observe Safety And Efficacy Of Toviaz (Registered) |
| Study Start Date : | November 2009 |
| Actual Primary Completion Date : | August 2014 |
| Actual Study Completion Date : | August 2014 |
Resource links provided by the National Library of Medicine
| Group/Cohort | Intervention/treatment |
|---|---|
|
OAB-Toviaz
All patients who enrolled in this study
|
Drug: Toviaz treatment
4 mg starting then can be followed by 8 mg |
Primary Outcome Measures :
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug. ]An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs.
- Investigator's Final Assessment of Effectiveness at the End of Study Treatment [ Time Frame: At the end of study treatment ]The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI).
Secondary Outcome Measures :
- Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment [ Time Frame: Baseline and at the end of study treatment ]The number of micturitions per 24 hours was recorded in the case report form (CRF) by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
- Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment [ Time Frame: Baseline and at the end of study treatment ]The number of urgency episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
- Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment [ Time Frame: Baseline and at the end of study treatment ]The number of UUI episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
- Participant Perception of Bladder Condition at the End of Study Treatment [ Time Frame: Baseline and at the end of study treatment ]Participant perception of bladder condition was recorded in the CRF by the investigator. Participants were asked at baseline (BL) and at the end of study treatment (EOT) if the extent to which their bladder condition caused them problems. The possible responses were: No Problem, Very Minor Problems, Minor Problems, Moderate Problems, Severe Problems, or Many Severe Problems.
- Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics [ Time Frame: At the end of study treatment ]Participants who were assessed as having improved from their baseline condition in the final efficacy assessment were considered as "effective". Baseline and treatment characteristics included: geriatric status (<65 years or ≥65 years), age categories, gender, weight categories, height categories, allergic history, duration of disease, past overactive bladder (OAB) treatment history, medical history, kidney and liver disorders, concomitant medication, total administration period of Toviaz, completion status, daily dose of Toviaz, and long term administration of Toviaz (<274 days and ≥274 days) .
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879398
Locations
Show 82 study locations
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00879398 |
| Other Study ID Numbers: |
A0221075 |
| First Posted: | April 10, 2009 Key Record Dates |
| Results First Posted: | September 4, 2015 |
| Last Update Posted: | October 21, 2015 |
| Last Verified: | September 2015 |
Additional relevant MeSH terms:
|
Urinary Bladder, Overactive Urinary Bladder Diseases Urologic Diseases Lower Urinary Tract Symptoms Urological Manifestations Fesoterodine Muscarinic Antagonists |
Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Urological Agents |