Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.
continuous registration method
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OAB-Toviaz | All patients who enrolled in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toviaz treatment | Drug | 4 mg starting then can be followed by 8 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | At the end of study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and at the end of study treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
- 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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soo Urology Clinic | Asan | Chungcheongnam-do | 336-010 | South Korea | ||
| Seo Kyung-Keun Urology Clinic |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
Participants were enrolled between November 2009 and August 2014 from 235 Korean medical care centers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Toviaz | Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 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. | 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. | 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) . | At the end of study treatment |
| Cheonan-si |
| Chungcheongnam-do |
| 330-730 |
| South Korea |
| Cheonan Medical Center | Cheonan-Si | Chungcheongnam-do | 330-930 | South Korea |
| Seoul Urology Clinic | Gongju | Chungcheongnam-do | 314-030 | South Korea |
| Lee Urology Clinic | Gongju | Chungcheongnam-do | 314-050 | South Korea |
| Moa gynecology | Nonsan | Chungcheongnam-do | 320-803 | South Korea |
| Song In-Ho Urology Clinic | Tangjin | Chungcheongnam-do | 343-920 | South Korea |
| Jung Woong Gyo Urology Clinic | Wŏnju | Gangwon-do | 220-903 | South Korea |
| Ansan Themapark Medical Center | Ansan | Gyeonggi-do | 425-020 | South Korea |
| Woosung Yusung Hospital | Ansan | Gyeonggi-do | 425-868 | South Korea |
| Kim Tae Joon Internal Medicine | Ansan-si | Gyeonggi-do | 425-778 | South Korea |
| Yoo And Lee Dematology Urology Clinic | Bucheon-si | Gyeonggi-do | 420-822 | South Korea |
| Myung Urology Hospital | Bucheon-si | Gyeonggi-do | 420-849 | South Korea |
| Gimpo Woori Hospital | Gimpsi | Gyeonggi-do | 415-020 | South Korea |
| Samsung Clinic | Goyang-si | Gyeonggi-do | 410-350 | South Korea |
| Hwang Family Medicine Clinic | Goyang-si | Gyeonggi-do | 411-848 | South Korea |
| Lee Urology Clinic | Namyangju | Gyeonggi-do | 472-900 | South Korea |
| Park Dermatology And Urology Clinic | Pyeongtaek-si | Gyeonggi-do | 450-828 | South Korea |
| Good morning Clinic, Pyeongtaek | Pyeongtaek-si | Gyeonggi-do | 450-833 | South Korea |
| Cheong Urology Clinic | Seongnam-si | Gyeonggi-do | 461-825 | South Korea |
| Na Seung Soo Urology Clinic | Seongnam-si | Gyeonggi-do | 462-817 | South Korea |
| Good Urology Clinic | Seongnam-si | Gyeonggi-do | 462-835 | South Korea |
| Seoul Urology Clinic | Seongnam-si | Gyeonggi-do | 463-050 | South Korea |
| Bes Top Urology Clinic | Seongnam-si | Gyeonggi-do | 463-805 | South Korea |
| Dongsuwon General Hospital | Suwon | Gyeonggi-do | 442-816 | South Korea |
| Kim Dae Sung Clinic | Uijeongbu-si | Gyeonggi-do | 480-800 | South Korea |
| Johan Urology Clinic | Uijeongbu-si | Gyeonggi-do | 480-848 | South Korea |
| Min Urology Clinic | Uijeongbu-si | Gyeonggi-do | 480-867 | South Korea |
| Choi Won Suk urology clinic | Yongin-si | Gyeonggi-do | 448-509 | South Korea |
| Haram Urology Clinic | Yongin-si | Gyeonggi-do | 449-924 | South Korea |
| Well Urology Clinic | Yongin | Gyeonggi-do | 446-597 | South Korea |
| Hankook General Hospital | Cheongju-si | North Chungcheong | 360-090 | South Korea |
| Shin Urology Clinic | Cheongju-si | North Chungcheong | 361-814 | South Korea |
| Lee Urology Clinic | Yeongdong-gun | North Chungcheong | South Korea |
| Chung Duck Young Urology Clinic | Daejeon | 300-160 | South Korea |
| Yeonhap Urology Clinic | Daejeon | 301-827 | South Korea |
| Taepyung urology clinic | Daejeon | 301-845 | South Korea |
| Ssen Urology Clinic | Daejeon | 302-831 | South Korea |
| Chung Duck Young Urology Clinic | Daejeon | South Korea |
| Kim Se Gyeom Urology Clinic | Daejeon | South Korea |
| Kwon Urology Clinic | Daejeon | South Korea |
| Yeonhap Urology Clinic | Daejeon | South Korea |
| Incheon Medical Center | Incheon | 401-711 | South Korea |
| Incheonsarang Hospital | Incheon | 402-201 | South Korea |
| Park Urology Clinic | Incheon | 403-733 | South Korea |
| Hanvit Urology Clinic | Incheon | 407-824 | South Korea |
| Lee and Lee dermatology urology clinic | Incheon | South Korea |
| Songdo Hospital | Seoul | 100-830 | South Korea |
| Dr. Cho & Lee's Urology Clinic | Seoul | 100-845 | South Korea |
| Won Urology Clinic | Seoul | 110-061 | South Korea |
| Lim Urology Clinic | Seoul | 121-806 | South Korea |
| Dong Seoul Hospital | Seoul | 130-811 | South Korea |
| Woo Tae Hyung urology clinic | Seoul | 130-846 | South Korea |
| S-Up Clinic | Seoul | 132-898 | South Korea |
| Park Yong Hyun Urology Clinic | Seoul | 133-867 | South Korea |
| Saerom urology clinic | Seoul | 134-840 | South Korea |
| Park Kyu Hong Urology Clinic | Seoul | 134-874 | South Korea |
| Seonreung Top Urology Clinic | Seoul | 135-922 | South Korea |
| Yonsei Woono Urology Clinic | Seoul | 135-931 | South Korea |
| Daehang Hospital | Seoul | 137-820 | South Korea |
| Park Byung Dae Urology Clinic | Seoul | 137-887 | South Korea |
| Jin Kilnam Urology Clinic | Seoul | 137-909 | South Korea |
| Bes Top Urology Clinic | Seoul | 138-727 | South Korea |
| Song Woung Soeg Urology Clinic | Seoul | 138-846 | South Korea |
| Kim Jun-Ho Urology Clinic | Seoul | 138-854 | South Korea |
| Hong Don Ho Urology Clinic | Seoul | 138-862 | South Korea |
| Boram St.Mary's Internal Medicine | Seoul | 139-820 | South Korea |
| Nowon Paik Urology Clinic | Seoul | 139-838 | South Korea |
| Su clinic | Seoul | 139-838 | South Korea |
| Uh's Urology Clinic | Seoul | 139-942 | South Korea |
| Seoul Top Clinic | Seoul | 142-874 | South Korea |
| Urotop Urology Clinic | Seoul | 142-878 | South Korea |
| Yoo Jong Keun Urology Clinic | Seoul | 142-878 | South Korea |
| Lim Urology Clinic | Seoul | 143-716 | South Korea |
| Seong Ae Hospital | Seoul | 150-960 | South Korea |
| Korea Ace Urology Clinic | Seoul | 151-892 | South Korea |
| Woo ri dermatology urology clinic | Seoul | 153-841 | South Korea |
| Bae Urology Hospital | Seoul | 153-858 | South Korea |
| Jung Ho Hyun Urology Clinic | Seoul | 156-832 | South Korea |
| Miz-Medi Hospital | Seoul | 157-723 | South Korea |
| Choi Urology Hospital | Seoul | 157-807 | South Korea |
| Ulsan Jeil Hopital | Ulsan | South Korea |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Analysis Set: regardless of treatment period, all participants who received study drug once or more, including dropouts due to adverse event (AE), were included in the safety analysis set. Participants who started Toviaz prior to the contract date or violated usage of maximum daily dose of 8 mg were excluded from the safety analysis set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Toviaz | Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Safety Analysis Set | Posted | Number | Percentage of Participants | From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug. |
|
|
| ||||||||||||||||||||||||||
| Primary | 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). | Per-Protocol (PP) Population: participants who had evaluable data and were eligible for the efficacy assessment of the approved indication. The method of last observation carried forward was used in the analysis of effectiveness endpoints. | Posted | Number | Percentage of Participants | At the end of study treatment |
|
| |||||||||||||||||||||||||||
| Secondary | 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. | PP Population; n refers to the number of participants with evaluable data. | Posted | Mean | Standard Deviation | Number of Episodes per 24 Hours | Baseline and at the end of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | PP Population; n refers to the number of participants with evaluable data. | Posted | Mean | Standard Deviation | Number of Episodes per 24 Hours | Baseline and at the end of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | PP Population; n refers to the number of participants with evaluable data. | Posted | Mean | Standard Deviation | Number of Episodes per 24 Hours | Baseline and at the end of study treatment |
|
| ||||||||||||||||||||||||||
| Secondary | 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. | PP Population | Posted | Number | Participants | Baseline and at the end of study treatment |
|
| |||||||||||||||||||||||||||
| Secondary | 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) . | PP Population | Posted | Number | 95% Confidence Interval | Percentage of Participants | At the end of study treatment |
|
|
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 same event may appear as both an AE and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Toviaz | Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity. | 0 | 3,107 | 219 | 3,107 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Mouth dry | Gastrointestinal disorders | WHO-ART version 092 | Non-systematic Assessment |
| |
| Micturition disorder | Renal and urinary disorders | WHO-ART version 092 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
|
|
|
|
|
|
|
|
|
|