Toviaz Post Marketing Surveillance Study

September 30, 2015 updated by: Pfizer

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Toviaz (Registered)

The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

continuous registration method

Study Type

Observational

Enrollment (Actual)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daejeon, Korea, Republic of, 300-160
        • Chung Duck Young Urology Clinic
      • Daejeon, Korea, Republic of, 301-827
        • Yeonhap Urology Clinic
      • Daejeon, Korea, Republic of, 301-845
        • Taepyung urology clinic
      • Daejeon, Korea, Republic of, 302-831
        • Ssen Urology Clinic
      • Daejeon, Korea, Republic of
        • Chung Duck Young Urology Clinic
      • Daejeon, Korea, Republic of
        • Kim Se Gyeom Urology Clinic
      • Daejeon, Korea, Republic of
        • Kwon Urology Clinic
      • Daejeon, Korea, Republic of
        • Yeonhap Urology Clinic
      • Incheon, Korea, Republic of, 401-711
        • Incheon Medical Center
      • Incheon, Korea, Republic of, 402-201
        • Incheonsarang Hospital
      • Incheon, Korea, Republic of, 403-733
        • Park Urology Clinic
      • Incheon, Korea, Republic of, 407-824
        • Hanvit Urology Clinic
      • Incheon, Korea, Republic of
        • Lee and Lee dermatology urology clinic
      • Seoul, Korea, Republic of, 100-830
        • Songdo Hospital
      • Seoul, Korea, Republic of, 100-845
        • Dr. Cho & Lee's Urology Clinic
      • Seoul, Korea, Republic of, 110-061
        • Won Urology Clinic
      • Seoul, Korea, Republic of, 121-806
        • Lim Urology Clinic
      • Seoul, Korea, Republic of, 130-811
        • Dong Seoul Hospital
      • Seoul, Korea, Republic of, 130-846
        • Woo Tae Hyung urology clinic
      • Seoul, Korea, Republic of, 132-898
        • S-Up Clinic
      • Seoul, Korea, Republic of, 133-867
        • Park Yong Hyun Urology Clinic
      • Seoul, Korea, Republic of, 134-840
        • Saerom urology clinic
      • Seoul, Korea, Republic of, 134-874
        • Park Kyu Hong Urology Clinic
      • Seoul, Korea, Republic of, 135-922
        • Seonreung Top Urology Clinic
      • Seoul, Korea, Republic of, 135-931
        • Yonsei Woono Urology Clinic
      • Seoul, Korea, Republic of, 137-820
        • Daehang Hospital
      • Seoul, Korea, Republic of, 137-887
        • Park Byung Dae Urology Clinic
      • Seoul, Korea, Republic of, 137-909
        • Jin Kilnam Urology Clinic
      • Seoul, Korea, Republic of, 138-727
        • Bes Top Urology Clinic
      • Seoul, Korea, Republic of, 138-846
        • Song Woung Soeg Urology Clinic
      • Seoul, Korea, Republic of, 138-854
        • Kim Jun-Ho Urology Clinic
      • Seoul, Korea, Republic of, 138-862
        • Hong Don Ho Urology Clinic
      • Seoul, Korea, Republic of, 139-820
        • Boram St.Mary's Internal Medicine
      • Seoul, Korea, Republic of, 139-838
        • Nowon Paik Urology Clinic
      • Seoul, Korea, Republic of, 139-838
        • Su clinic
      • Seoul, Korea, Republic of, 139-942
        • Uh's Urology Clinic
      • Seoul, Korea, Republic of, 142-874
        • Seoul Top Clinic
      • Seoul, Korea, Republic of, 142-878
        • Urotop Urology Clinic
      • Seoul, Korea, Republic of, 142-878
        • Yoo Jong Keun Urology Clinic
      • Seoul, Korea, Republic of, 143-716
        • Lim Urology Clinic
      • Seoul, Korea, Republic of, 150-960
        • Seong Ae Hospital
      • Seoul, Korea, Republic of, 151-892
        • Korea Ace Urology Clinic
      • Seoul, Korea, Republic of, 153-841
        • Woo ri dermatology urology clinic
      • Seoul, Korea, Republic of, 153-858
        • Bae Urology Hospital
      • Seoul, Korea, Republic of, 156-832
        • Jung Ho Hyun Urology Clinic
      • Seoul, Korea, Republic of, 157-723
        • Miz-Medi Hospital
      • Seoul, Korea, Republic of, 157-807
        • Choi Urology Hospital
      • Ulsan, Korea, Republic of
        • Ulsan Jeil Hopital
    • Chungcheongbuk-do
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 360-090
        • Hankook General Hospital
      • Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 361-814
        • Shin Urology Clinic
      • Yeongdong-gun, Chungcheongbuk-do, Korea, Republic of
        • Lee Urology Clinic
    • Chungcheongnam-Do
      • Dangjin-si, Chungcheongnam-Do, Korea, Republic of, 343-920
        • Song In-Ho Urology Clinic
      • Gongju-si, Chungcheongnam-Do, Korea, Republic of, 314-050
        • Lee Urology Clinic
    • Chungcheongnam-do
      • Asan-si, Chungcheongnam-do, Korea, Republic of, 336-010
        • Soo Urology Clinic
      • Cheonan-Si, Chungcheongnam-do, Korea, Republic of, 330-930
        • Cheonan Medical Center
      • Cheonan-si, Chungcheongnam-do, Korea, Republic of, 330-730
        • Seo Kyung-Keun Urology Clinic
      • Gongju-si, Chungcheongnam-do, Korea, Republic of, 314-030
        • Seoul Urology Clinic
      • Nonsan-si, Chungcheongnam-do, Korea, Republic of, 320-803
        • Moa gynecology
    • Gangwon-do
      • Wonju-si, Gangwon-do, Korea, Republic of, 220-903
        • Jung Woong Gyo Urology Clinic
    • Gyeonggi-Do
      • Ansan, Gyeonggi-Do, Korea, Republic of, 425-020
        • Ansan Themapark Medical Center
      • Ansan, Gyeonggi-Do, Korea, Republic of, 425-868
        • Woosung Yusung Hospital
      • Ansan-si, Gyeonggi-Do, Korea, Republic of, 425-778
        • Kim Tae Joon Internal Medicine
      • Bucheon-si, Gyeonggi-Do, Korea, Republic of, 420-822
        • Yoo And Lee Dematology Urology Clinic
      • Bucheon-si, Gyeonggi-Do, Korea, Republic of, 420-849
        • Myung Urology Hospital
      • Goyang-Si, Gyeonggi-Do, Korea, Republic of, 411-848
        • Hwang Family Medicine Clinic
      • Goyang-si, Gyeonggi-Do, Korea, Republic of, 410-350
        • Samsung Clinic
      • Pyeongtaek, Gyeonggi-Do, Korea, Republic of, 450-828
        • Park Dermatology And Urology Clinic
      • Seongnam, Gyeonggi-Do, Korea, Republic of, 463-050
        • Seoul Urology Clinic
      • Seongnam-si, Gyeonggi-Do, Korea, Republic of, 462-817
        • Na Seung Soo Urology Clinic
      • Uijeongbu-si, Gyeonggi-Do, Korea, Republic of, 480-800
        • Kim Dae Sung Clinic
      • Uijeongbu-si, Gyeonggi-Do, Korea, Republic of, 480-867
        • Min Urology Clinic
      • Yongin, Gyeonggi-Do, Korea, Republic of, 446-597
        • Well Urology Clinic
      • Yongin-si, Gyeonggi-Do, Korea, Republic of, 449-924
        • Haram Urology Clinic
    • Gyeonggi-do
      • Gimpsi, Gyeonggi-do, Korea, Republic of, 415-020
        • Gimpo Woori Hospital
      • Namyangju-si, Gyeonggi-do, Korea, Republic of, 472-900
        • Lee Urology Clinic
      • Pyeongtaek, Gyeonggi-do, Korea, Republic of, 450-833
        • Good morning Clinic, Pyeongtaek
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 461-825
        • Cheong Urology Clinic
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 462-835
        • Good Urology Clinic
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-805
        • Bes Top Urology Clinic
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 442-816
        • Dongsuwon General Hospital
      • Uijeongbu-si, Gyeonggi-do, Korea, Republic of, 480-848
        • Johan Urology Clinic
      • Yongin-si, Gyeonggi-do, Korea, Republic of, 448-509
        • Choi Won Suk urology clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.
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).
At the end of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and at the end of study treatment
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.
Baseline and at the end of study treatment
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.
Baseline and at the end of study treatment
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.
Baseline and at the end of study treatment
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) .
At the end of study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 9, 2009

First Submitted That Met QC Criteria

April 9, 2009

First Posted (Estimate)

April 10, 2009

Study Record Updates

Last Update Posted (Estimate)

October 21, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0221075

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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