Toviaz Post Marketing Surveillance Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00879398
First received: April 9, 2009
Last updated: June 20, 2014
Last verified: June 2014
  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879398

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  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: June 20, 2014
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 July 10, 2014