Toviaz Post Marketing Surveillance Study

Overactive Bladder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879398
• Other study ID #: A0221075
• Status: Completed
• Phase: N/A
• First received: April 9, 2009
• Last updated: September 30, 2015
• Start date: November 2009
• Est. completion date: August 2014

Study information

• Verified date: September 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical 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.

Description:

continuous registration method

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• Toviaz treatment
4 mg starting then can be followed by 8 mg

Locations

Country	Name	City	State
Korea, Republic of	Ansan Themapark Medical Center	Ansan	Gyeonggi-Do
Korea, Republic of	Woosung Yusung Hospital	Ansan	Gyeonggi-Do
Korea, Republic of	Kim Tae Joon Internal Medicine	Ansan-si	Gyeonggi-Do
Korea, Republic of	Soo Urology Clinic	Asan-si	Chungcheongnam-do
Korea, Republic of	Myung Urology Hospital	Bucheon-si	Gyeonggi-Do
Korea, Republic of	Yoo And Lee Dematology Urology Clinic	Bucheon-si	Gyeonggi-Do
Korea, Republic of	Cheonan Medical Center	Cheonan-Si	Chungcheongnam-do
Korea, Republic of	Seo Kyung-Keun Urology Clinic	Cheonan-si	Chungcheongnam-do
Korea, Republic of	Hankook General Hospital	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	Shin Urology Clinic	Cheongju-si	Chungcheongbuk-do
Korea, Republic of	Chung Duck Young 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	Ssen Urology Clinic	Daejeon
Korea, Republic of	Taepyung urology clinic	Daejeon
Korea, Republic of	Yeonhap Urology Clinic	Daejeon
Korea, Republic of	Yeonhap Urology Clinic	Daejeon
Korea, Republic of	Song In-Ho Urology Clinic	Dangjin-si	Chungcheongnam-Do
Korea, Republic of	Gimpo Woori Hospital	Gimpsi	Gyeonggi-do
Korea, Republic of	Lee Urology Clinic	Gongju-si	Chungcheongnam-Do
Korea, Republic of	Seoul Urology Clinic	Gongju-si	Chungcheongnam-do
Korea, Republic of	Hwang Family Medicine Clinic	Goyang-Si	Gyeonggi-Do
Korea, Republic of	Samsung Clinic	Goyang-si	Gyeonggi-Do
Korea, Republic of	Hanvit Urology Clinic	Incheon
Korea, Republic of	Incheon Medical Center	Incheon
Korea, Republic of	Incheonsarang Hospital	Incheon
Korea, Republic of	Lee and Lee dermatology urology clinic	Incheon
Korea, Republic of	Park Urology Clinic	Incheon
Korea, Republic of	Lee Urology Clinic	Namyangju-si	Gyeonggi-do
Korea, Republic of	Moa gynecology	Nonsan-si	Chungcheongnam-do
Korea, Republic of	Good morning Clinic, Pyeongtaek	Pyeongtaek	Gyeonggi-do
Korea, Republic of	Park Dermatology And Urology Clinic	Pyeongtaek	Gyeonggi-Do
Korea, Republic of	Seoul Urology Clinic	Seongnam	Gyeonggi-Do
Korea, Republic of	Bes Top Urology Clinic	Seongnam-si	Gyeonggi-do
Korea, Republic of	Cheong Urology Clinic	Seongnam-si	Gyeonggi-do
Korea, Republic of	Good Urology Clinic	Seongnam-si	Gyeonggi-do
Korea, Republic of	Na Seung Soo Urology Clinic	Seongnam-si	Gyeonggi-Do
Korea, Republic of	Bae Urology Hospital	Seoul
Korea, Republic of	Bes Top Urology Clinic	Seoul
Korea, Republic of	Boram St.Mary's Internal Medicine	Seoul
Korea, Republic of	Choi Urology Hospital	Seoul
Korea, Republic of	Daehang Hospital	Seoul
Korea, Republic of	Dong Seoul Hospital	Seoul
Korea, Republic of	Dr. Cho & Lee's Urology Clinic	Seoul
Korea, Republic of	Hong Don Ho Urology Clinic	Seoul
Korea, Republic of	Jin Kilnam Urology Clinic	Seoul
Korea, Republic of	Jung Ho Hyun Urology Clinic	Seoul
Korea, Republic of	Kim Jun-Ho Urology Clinic	Seoul
Korea, Republic of	Korea Ace Urology Clinic	Seoul
Korea, Republic of	Lim Urology Clinic	Seoul
Korea, Republic of	Lim Urology Clinic	Seoul
Korea, Republic of	Miz-Medi Hospital	Seoul
Korea, Republic of	Nowon Paik Urology Clinic	Seoul
Korea, Republic of	Park Byung Dae Urology Clinic	Seoul
Korea, Republic of	Park Kyu Hong Urology Clinic	Seoul
Korea, Republic of	Park Yong Hyun Urology Clinic	Seoul
Korea, Republic of	S-Up Clinic	Seoul
Korea, Republic of	Saerom urology clinic	Seoul
Korea, Republic of	Seong Ae Hospital	Seoul
Korea, Republic of	Seonreung Top Urology Clinic	Seoul
Korea, Republic of	Seoul Top Clinic	Seoul
Korea, Republic of	Song Woung Soeg Urology Clinic	Seoul
Korea, Republic of	Songdo Hospital	Seoul
Korea, Republic of	Su clinic	Seoul
Korea, Republic of	Uh's Urology Clinic	Seoul
Korea, Republic of	Urotop Urology Clinic	Seoul
Korea, Republic of	Won Urology Clinic	Seoul
Korea, Republic of	Woo ri dermatology urology clinic	Seoul
Korea, Republic of	Woo Tae Hyung urology clinic	Seoul
Korea, Republic of	Yonsei Woono Urology Clinic	Seoul
Korea, Republic of	Yoo Jong Keun Urology Clinic	Seoul
Korea, Republic of	Dongsuwon General Hospital	Suwon-si	Gyeonggi-do
Korea, Republic of	Johan Urology Clinic	Uijeongbu-si	Gyeonggi-do
Korea, Republic of	Kim Dae Sung Clinic	Uijeongbu-si	Gyeonggi-Do
Korea, Republic of	Min Urology Clinic	Uijeongbu-si	Gyeonggi-Do
Korea, Republic of	Ulsan Jeil Hopital	Ulsan
Korea, Republic of	Jung Woong Gyo Urology Clinic	Wonju-si	Gangwon-do
Korea, Republic of	Lee Urology Clinic	Yeongdong-gun	Chungcheongbuk-do
Korea, Republic of	Well Urology Clinic	Yongin	Gyeonggi-Do
Korea, Republic of	Choi Won Suk urology clinic	Yongin-si	Gyeonggi-do
Korea, Republic of	Haram Urology Clinic	Yongin-si	Gyeonggi-Do

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.	Yes
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).	At the end of study treatment	No
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.	Baseline and at the end of study treatment	No
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.	Baseline and at the end of study treatment	No
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.	Baseline and at the end of study treatment	No
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.	Baseline and at the end of study treatment	No
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) .	At the end of study treatment	No

External Links

•   To obtain contact information for a study center near you, click here.