Clinical trial NCT00879398: Toviaz Post Marketing Surveillance Study
Official title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Toviaz (Registered)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overactive Bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-04-10
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

Detailed description: continuous registration method

Eligibility 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)

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.
measure: Investigator's Final Assessment of Effectiveness at the End of Study Treatment
timeFrame: At the end of study treatment
Secondary outcomes:
measure: Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment
timeFrame: Baseline and at the end of study treatment
measure: Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment
timeFrame: Baseline and at the end of study treatment
measure: Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment
timeFrame: Baseline and at the end of study treatment
measure: Participant Perception of Bladder Condition at the End of Study Treatment
timeFrame: Baseline and at the end of study treatment
measure: Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
timeFrame: At the end of study treatment
Other outcomes:
Locations:
city: Cheongju-si
country: Korea, Republic of
facility: Hankook General Hospital
state: Chungcheongbuk-do
city: Cheongju-si
country: Korea, Republic of
facility: Shin Urology Clinic
state: Chungcheongbuk-do
city: Yeongdong-gun
country: Korea, Republic of
facility: Lee Urology Clinic
state: Chungcheongbuk-do
city: Asan-si
country: Korea, Republic of
facility: Soo Urology Clinic
state: Chungcheongnam-do
city: Cheonan-si
country: Korea, Republic of
facility: Seo Kyung-Keun Urology Clinic
state: Chungcheongnam-do
city: Cheonan-Si
country: Korea, Republic of
facility: Cheonan Medical Center
state: Chungcheongnam-do
city: Dangjin-si
country: Korea, Republic of
facility: Song In-Ho Urology Clinic
state: Chungcheongnam-Do
city: Gongju-si
country: Korea, Republic of
facility: Seoul Urology Clinic
state: Chungcheongnam-do
city: Gongju-si
country: Korea, Republic of
facility: Lee Urology Clinic
state: Chungcheongnam-Do
city: Nonsan-si
country: Korea, Republic of
facility: Moa gynecology
state: Chungcheongnam-do
city: Wonju-si
country: Korea, Republic of
facility: Jung Woong Gyo Urology Clinic
state: Gangwon-do
city: Ansan-si
country: Korea, Republic of
facility: Kim Tae Joon Internal Medicine
state: Gyeonggi-Do
city: Ansan
country: Korea, Republic of
facility: Ansan Themapark Medical Center
state: Gyeonggi-Do
city: Ansan
country: Korea, Republic of
facility: Woosung Yusung Hospital
state: Gyeonggi-Do
city: Bucheon-si
country: Korea, Republic of
facility: Yoo And Lee Dematology Urology Clinic
state: Gyeonggi-Do
city: Bucheon-si
country: Korea, Republic of
facility: Myung Urology Hospital
state: Gyeonggi-Do
city: Gimpsi
country: Korea, Republic of
facility: Gimpo Woori Hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Samsung Clinic
state: Gyeonggi-Do
city: Goyang-Si
country: Korea, Republic of
facility: Hwang Family Medicine Clinic
state: Gyeonggi-Do
city: Namyangju-si
country: Korea, Republic of
facility: Lee Urology Clinic
state: Gyeonggi-do
city: Pyeongtaek
country: Korea, Republic of
facility: Park Dermatology And Urology Clinic
state: Gyeonggi-Do
city: Pyeongtaek
country: Korea, Republic of
facility: Good morning Clinic, Pyeongtaek
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Cheong Urology Clinic
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Na Seung Soo Urology Clinic
state: Gyeonggi-Do
city: Seongnam-si
country: Korea, Republic of
facility: Good Urology Clinic
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Bes Top Urology Clinic
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul Urology Clinic
state: Gyeonggi-Do
city: Suwon-si
country: Korea, Republic of
facility: Dongsuwon General Hospital
state: Gyeonggi-do
city: Uijeongbu-si
country: Korea, Republic of
facility: Kim Dae Sung Clinic
state: Gyeonggi-Do
city: Uijeongbu-si
country: Korea, Republic of
facility: Johan Urology Clinic
state: Gyeonggi-do
city: Uijeongbu-si
country: Korea, Republic of
facility: Min Urology Clinic
state: Gyeonggi-Do
city: Yongin-si
country: Korea, Republic of
facility: Choi Won Suk urology clinic
state: Gyeonggi-do
city: Yongin-si
country: Korea, Republic of
facility: Haram Urology Clinic
state: Gyeonggi-Do
city: Yongin
country: Korea, Republic of
facility: Well Urology Clinic
state: Gyeonggi-Do
city: Daejeon
country: Korea, Republic of
facility: Chung Duck Young Urology Clinic
city: Daejeon
country: Korea, Republic of
facility: Yeonhap Urology Clinic
city: Daejeon
country: Korea, Republic of
facility: Taepyung urology clinic
city: Daejeon
country: Korea, Republic of
facility: Ssen Urology Clinic
city: Daejeon
country: Korea, Republic of
facility: Chung Duck Young Urology Clinic
city: Daejeon
country: Korea, Republic of
facility: Kim Se Gyeom Urology Clinic
city: Daejeon
country: Korea, Republic of
facility: Kwon Urology Clinic
city: Daejeon
country: Korea, Republic of
facility: Yeonhap Urology Clinic
city: Incheon
country: Korea, Republic of
facility: Incheon Medical Center
city: Incheon
country: Korea, Republic of
facility: Incheonsarang Hospital
city: Incheon
country: Korea, Republic of
facility: Park Urology Clinic
city: Incheon
country: Korea, Republic of
facility: Hanvit Urology Clinic
city: Incheon
country: Korea, Republic of
facility: Lee and Lee dermatology urology clinic
city: Seoul
country: Korea, Republic of
facility: Songdo Hospital
city: Seoul
country: Korea, Republic of
facility: Dr. Cho & Lee's Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Won Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Lim Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Dong Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Woo Tae Hyung urology clinic
city: Seoul
country: Korea, Republic of
facility: S-Up Clinic
city: Seoul
country: Korea, Republic of
facility: Park Yong Hyun Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Saerom urology clinic
city: Seoul
country: Korea, Republic of
facility: Park Kyu Hong Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Seonreung Top Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Yonsei Woono Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Daehang Hospital
city: Seoul
country: Korea, Republic of
facility: Park Byung Dae Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Jin Kilnam Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Bes Top Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Song Woung Soeg Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Kim Jun-Ho Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Hong Don Ho Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Boram St.Mary's Internal Medicine
city: Seoul
country: Korea, Republic of
facility: Nowon Paik Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Su clinic
city: Seoul
country: Korea, Republic of
facility: Uh's Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Seoul Top Clinic
city: Seoul
country: Korea, Republic of
facility: Urotop Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Yoo Jong Keun Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Lim Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Seong Ae Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Ace Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Woo ri dermatology urology clinic
city: Seoul
country: Korea, Republic of
facility: Bae Urology Hospital
city: Seoul
country: Korea, Republic of
facility: Jung Ho Hyun Urology Clinic
city: Seoul
country: Korea, Republic of
facility: Miz-Medi Hospital
city: Seoul
country: Korea, Republic of
facility: Choi Urology Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan Jeil Hopital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: