Toviaz Post Marketing Surveillance Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00879398
First received: April 9, 2009
Last updated: September 30, 2015
Last verified: September 2015
  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
Overactive Bladder
Drug: Toviaz treatment

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 (Registered)

Resource links provided by NLM:


Further study details as provided by Pfizer:

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. ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) .


Enrollment: 3000
Study Start Date: November 2009
Study Completion Date: August 2014
Primary Completion Date: August 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   (Adult, Senior)
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

  Show 82 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00879398     History of Changes
Other Study ID Numbers: A0221075 
Study First Received: April 9, 2009
Results First Received: August 6, 2015
Last Updated: September 30, 2015
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents

ClinicalTrials.gov processed this record on August 25, 2016