Detrol LA In Men With Overactive Bladder.

Overactive Bladder (OAB) Clinical Trial

Official title:

A Randomized, Double Blind, Placebo Controlled Detrol LA "Add-On" To Alpha-Blocker Study In Men With Persistent Overactive Bladder Symptoms Of Urinary Frequency And Urgency With/Without Urgency Incontinence After Previous Monotherapy With Alpha Blocker.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00282932
• Other study ID #: A6121127
• Status: Completed
• Phase: Phase 4
• Start date: January 2006
• Est. completion date: May 14, 2007

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An interventional active/placebo double blinded parallel randomized controlled study in which at 12 weeks of treatment, the primary endpoint of patient perception of bladder condition is measured along with associated safety and other secondary endpoints like bladder diary endpoints, quality of life and patient treatment satisfaction. Patients included in the study must have symptoms of OAB (frequency of at least 8 per day and Urgency of at least 1 episode per day confirmed by bladder diary). Patients are not eligible to enroll in the study if they have/had significant hepatic or renal disease, history of radiation treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: May 14, 2007
• Est. primary completion date: May 1, 2007
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Symptoms of OAB (frequency more than 8 per day and Urgency more than 1 episode per day confirmed by bladder diary)

Exclusion Criteria:

• Significant hepatic or renal disease, history of radiation treatment

Related Conditions & MeSH terms

• Overactive Bladder (OAB)
• Urinary Bladder, Overactive

Intervention

Drug:
• Detrol LA

Locations

Country	Name	City	State
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Kingston	Ontario
Canada	Pfizer Investigational Site	London	Ontario
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Montreal	Quebec
Canada	Pfizer Investigational Site	Oakville	Ontario
Canada	Pfizer Investigational Site	Pointe-Claire	Quebec
Canada	Pfizer Investigational Site	Surrey	British Columbia
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Victoria	British Columbia
Denmark	Pfizer Investigational Site	Aalborg
Denmark	Pfizer Investigational Site	Herlev
Denmark	Pfizer Investigational Site	Nykobing Falster
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Duisburg
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Muelheim A.d. Ruhr
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Rosenheim
Germany	Pfizer Investigational Site	Starnberg
Italy	Pfizer Investigational Site	Latina
Italy	Pfizer Investigational Site	Padova
Korea, Republic of	Pfizer Investigational Site	Bucheon-si	Gyunggi-do
Korea, Republic of	Pfizer Investigational Site	Busan
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Mexico	Pfizer Investigational Site	Durango
Mexico	Pfizer Investigational Site	Durango
Mexico	Pfizer Investigational Site	Guadalajara	Jalisco
Mexico	Pfizer Investigational Site	Tlalpan	México DF
Mexico	Pfizer Investigational Site	Zapopan	Jalisco
Norway	Pfizer Investigational Site	Bodø
Norway	Pfizer Investigational Site	Moelv
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Kosice
Slovakia	Pfizer Investigational Site	Malacky
Slovakia	Pfizer Investigational Site	Martin
Slovakia	Pfizer Investigational Site	Skalica
South Africa	Pfizer Investigational Site	Bloemfontein	Free State
South Africa	Pfizer Investigational Site	Bloemfontein	Free State
South Africa	Pfizer Investigational Site	Cape Town
South Africa	Pfizer Investigational Site	Durban	Kwa Zulu Natal
South Africa	Pfizer Investigational Site	Parktown	Gauteng Province
South Africa	Pfizer Investigational Site	Pietermaritzburg	Kwa Zulu Natal
Spain	Pfizer Investigational Site	A Coruna	A Coruña
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Granada
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Madrid
Spain	Pfizer Investigational Site	Palma de Mallorca	Islas Baleares
Spain	Pfizer Investigational Site	Valencia
Sweden	Pfizer Investigational Site	Boras
Sweden	Pfizer Investigational Site	Huskvarna
Sweden	Pfizer Investigational Site	Lund
Sweden	Pfizer Investigational Site	Skovde
Taiwan	Pfizer Investigational Site	Hualien
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Taipei
Taiwan	Pfizer Investigational Site	Taipei
Turkey	Pfizer Investigational Site	Adana
Turkey	Pfizer Investigational Site	Istanbul
Turkey	Pfizer Investigational Site	Izmir
Turkey	Pfizer Investigational Site	Sihhiye-Ankara
United Kingdom	Pfizer Investigational Site	Bristol	Avon
United Kingdom	Pfizer Investigational Site	Crewe	Cheshire
United Kingdom	Pfizer Investigational Site	London
United Kingdom	Pfizer Investigational Site	Taunton	Somerset
United States	Pfizer Investigational Site	Anaheim	California
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Iowa City	Iowa
United States	Pfizer Investigational Site	La Mesa	California
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	State College	Pennsylvania
United States	Pfizer Investigational Site	Watertown	Massachusetts
United States	Pfizer Investigational Site	Westampton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

United States,  Canada,  Denmark,  Germany,  Italy,  Korea, Republic of,  Mexico,  Norway,  Slovakia,  South Africa,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Perception of Bladder Condition at 12 weeks of treatment
Secondary	1)To evaluate the additional benefit of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence: a)On OAB symptoms as
Secondary	assessed by 5-day voiding bladder diaries including Urinary Sensation Scale, b)On symptoms as assessed by the International Prostate Symptom Score (IPSS), c)On patient perception of treatment benefit as assessed by the Patient Perception of Treatment
Secondary	Benefit Questionnaire (PPTB) , d)On patient perception of bladder condition as assessed by the change in the PPBC after 4 weeks of treatment, e)On bothersome quality of life (QoL) symptoms as assessed by the Overactive Bladder Questionnaire (OAB-q),
Secondary	f)On sexual QoL as assessed by the ICIQ-MLUTSsex Questionnaire , g)On patient satisfaction with medication as assessed by the Overactive Bladder Treatment Satisfaction Questionnaires (OAB-s), h)On nocturia bothersome measure as assessed by the Nocturia
Secondary	Quality-of-Life Questionnaire, 2)To evaluate the safety and tolerability of 'Add-On' tolterodine L-tartrate ER (Detrol LA?), vs. placebo, to alpha-blocker therapy in men with persistent OAB symptoms of urinary frequency and urgency with/without urgency
Secondary	incontinence.

External Links

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