Overactive BladderNCT00879398
Toviaz Post Marketing Surveillance Study
An observational study of Overactive Bladder, run by Pfizer at 82 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Toviaz treatment
- How many people
- 3,000 participants
- Where
- 82 sitesSouth Korea
- Study dates
- Nov 2009to Aug 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
82 sites in 1 country.
82 sites in 1 country
South Korea82 sites
Ansan Themapark Medical Center
Ansan, Gyeonggi-do, 425-020
Woosung Yusung Hospital
Ansan, Gyeonggi-do, 425-868
Kim Tae Joon Internal Medicine
Ansan-si, Gyeonggi-do, 425-778
Soo Urology Clinic
Asan, Chungcheongnam-do, 336-010
Yoo And Lee Dematology Urology Clinic
Bucheon-si, Gyeonggi-do, 420-822
Myung Urology Hospital
Bucheon-si, Gyeonggi-do, 420-849
Seo Kyung-Keun Urology Clinic
Cheonan-si, Chungcheongnam-do, 330-730
Cheonan Medical Center
Cheonan-Si, Chungcheongnam-do, 330-930
Hankook General Hospital
Cheongju-si, North Chungcheong, 360-090
Shin Urology Clinic
Cheongju-si, North Chungcheong, 361-814
Chung Duck Young Urology Clinic
Daejeon, 300-160
Yeonhap Urology Clinic
Daejeon, 301-827
Taepyung urology clinic
Daejeon, 301-845
Ssen Urology Clinic
Daejeon, 302-831
Chung Duck Young Urology Clinic
Daejeon
Kim Se Gyeom Urology Clinic
Daejeon
Kwon Urology Clinic
Daejeon
Yeonhap Urology Clinic
Daejeon
Gimpo Woori Hospital
Gimpsi, Gyeonggi-do, 415-020
Seoul Urology Clinic
Gongju, Chungcheongnam-do, 314-030
Lee Urology Clinic
Gongju, Chungcheongnam-do, 314-050
Samsung Clinic
Goyang-si, Gyeonggi-do, 410-350
Hwang Family Medicine Clinic
Goyang-si, Gyeonggi-do, 411-848
Incheon Medical Center
Incheon, 401-711
Incheonsarang Hospital
Incheon, 402-201
Park Urology Clinic
Incheon, 403-733
Hanvit Urology Clinic
Incheon, 407-824
Lee and Lee dermatology urology clinic
Incheon
Lee Urology Clinic
Namyangju, Gyeonggi-do, 472-900
Moa gynecology
Nonsan, Chungcheongnam-do, 320-803
Park Dermatology And Urology Clinic
Pyeongtaek-si, Gyeonggi-do, 450-828
Good morning Clinic, Pyeongtaek
Pyeongtaek-si, Gyeonggi-do, 450-833
Cheong Urology Clinic
Seongnam-si, Gyeonggi-do, 461-825
Na Seung Soo Urology Clinic
Seongnam-si, Gyeonggi-do, 462-817
Good Urology Clinic
Seongnam-si, Gyeonggi-do, 462-835
Seoul Urology Clinic
Seongnam-si, Gyeonggi-do, 463-050
Bes Top Urology Clinic
Seongnam-si, Gyeonggi-do, 463-805
Songdo Hospital
Seoul, 100-830
Dr. Cho & Lee's Urology Clinic
Seoul, 100-845
Won Urology Clinic
Seoul, 110-061
Lim Urology Clinic
Seoul, 121-806
Dong Seoul Hospital
Seoul, 130-811
Woo Tae Hyung urology clinic
Seoul, 130-846
S-Up Clinic
Seoul, 132-898
Park Yong Hyun Urology Clinic
Seoul, 133-867
Saerom urology clinic
Seoul, 134-840
Park Kyu Hong Urology Clinic
Seoul, 134-874
Seonreung Top Urology Clinic
Seoul, 135-922
Yonsei Woono Urology Clinic
Seoul, 135-931
Daehang Hospital
Seoul, 137-820
Park Byung Dae Urology Clinic
Seoul, 137-887
Jin Kilnam Urology Clinic
Seoul, 137-909
Bes Top Urology Clinic
Seoul, 138-727
Song Woung Soeg Urology Clinic
Seoul, 138-846
Kim Jun-Ho Urology Clinic
Seoul, 138-854
Hong Don Ho Urology Clinic
Seoul, 138-862
Boram St.Mary's Internal Medicine
Seoul, 139-820
Nowon Paik Urology Clinic
Seoul, 139-838
Su clinic
Seoul, 139-838
Uh's Urology Clinic
Seoul, 139-942
Seoul Top Clinic
Seoul, 142-874
Urotop Urology Clinic
Seoul, 142-878
Yoo Jong Keun Urology Clinic
Seoul, 142-878
Lim Urology Clinic
Seoul, 143-716
Seong Ae Hospital
Seoul, 150-960
Korea Ace Urology Clinic
Seoul, 151-892
Woo ri dermatology urology clinic
Seoul, 153-841
Bae Urology Hospital
Seoul, 153-858
Jung Ho Hyun Urology Clinic
Seoul, 156-832
Miz-Medi Hospital
Seoul, 157-723
Choi Urology Hospital
Seoul, 157-807
Dongsuwon General Hospital
Suwon, Gyeonggi-do, 442-816
Song In-Ho Urology Clinic
Tangjin, Chungcheongnam-do, 343-920
Kim Dae Sung Clinic
Uijeongbu-si, Gyeonggi-do, 480-800
Johan Urology Clinic
Uijeongbu-si, Gyeonggi-do, 480-848
Min Urology Clinic
Uijeongbu-si, Gyeonggi-do, 480-867
Ulsan Jeil Hopital
Ulsan
Jung Woong Gyo Urology Clinic
Wŏnju, Gangwon-do, 220-903
Lee Urology Clinic
Yeongdong-gun, North Chungcheong
Well Urology Clinic
Yongin, Gyeonggi-do, 446-597
Choi Won Suk urology clinic
Yongin-si, Gyeonggi-do, 448-509
Haram Urology Clinic
Yongin-si, Gyeonggi-do, 449-924
About this study
Official title: 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.
Read the detailed description
continuous registration method
- Conditions
- Overactive Bladder
- Being tested
- Toviaz treatment
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toviaz treatmentDrug
4 mg starting then can be followed by 8 mg
| Study group | Role | What they receive |
|---|---|---|
| OAB-Toviaz | All patients who enrolled in this study Receives: Drug: Toviaz treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Measured: 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
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).
Measured: At the end of study treatment
Secondary outcomes (5)
Change From Baseline in Number of Micturitions Per 24 Hours 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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline and at the end of study treatment
Participant Perception of Bladder Condition 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.
Measured: Baseline and at the end of study treatment
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
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) .
Measured: At the end of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2009 (estimated)
- Study startNov 2009
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879398
- Sponsor's protocol ID
- A0221075
- Status last verified
- Sep 2015
- First submitted
- 9 Apr 2009
- Last updated
- 21 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance Study To Observe Safety And Efficacy Of Toviaz (Registered)
- ClinicalTrials.gov ID
- NCT00879398
- Acronym / sponsor ID
- A0221075
- Conditions
- Overactive Bladder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Apr 2009 (estimated)
- Results
- Posted 4 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.
Detailed description
continuous registration method
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OAB-Toviaz | – | Drug: Toviaz treatmentAll patients who enrolled in this study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toviaz treatment4 mg starting then can be followed by 8 mg | Drug | OAB-Toviaz |
Primary outcome
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).
5 secondary outcomes
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
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
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
Participant Perception of Bladder Condition at the End of Study Treatment
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
82 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overactive Bladder, run by Pfizer at 82 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 82 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2015.