Clinical trial NCT00479505: Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder
Official title: A Multi-Center, Randomised, Parallel Group, Double-Blind, Placebo Controlled Estimation Study To Assess The Efficacy And Safety Of Modified Release UK-369,003 In The Treatment Of Men With Storage Lower Urinary Tract Symptoms (LUTS) With And Without Erectile Dysfunction (ED).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Bladder, Overactive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-05-28
Enrollment: 275
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.


Eligibility criteria: Inclusion Criteria:

* Male subjects aged 18 years and above
* documented clinical diagnosis of overactive bladder with urinary frequency \>= 8 times / 24 hours and number of urgency episodes \> 1 episode / 24 hours.

Exclusion Criteria:

* Neurological diseases known to affect bladder function.
* Urinary tract infection.

Primary outcomes:
measure: This is an estimation study with no primary endpoint. There are efficacy endpoints.
timeFrame: 12 Weeks
Secondary outcomes:
measure: Patient reported treatment impact questionnaire.
timeFrame: 12 Weeks
measure: Lower urinary tract symptoms diary.
timeFrame: 12 Weeks
measure: International prostate symptom score questionnaire.
timeFrame: 12 Weeks
measure: OAB-q short form questionnaire.
timeFrame: 12 Weeks
measure: Patient perception of bladder control questionnaire.
timeFrame: 12 Weeks
measure: International index of erectile function questionnaire.
timeFrame: 12 Weeks
measure: International consultation on incontinence questionnaire.
timeFrame: 12 Weeks
measure: Quality of erection questionnaire.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Miranda
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Kippa Ring
country: Australia
facility: Pfizer Investigational Site
state: Queensland
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Barrie
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kitchener
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Santiago
country: Chile
facility: Pfizer Investigational Site
state: RM
city: Rancagua
country: Chile
facility: Pfizer Investigational Site
state: VI Región
city: Medellin
country: Colombia
facility: Pfizer Investigational Site
state: Antioquia
city: Bogota
country: Colombia
facility: Pfizer Investigational Site
state: Cundinamarca
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Kouvola
country: Finland
facility: Pfizer Investigational Site
city: Oulu
country: Finland
facility: Pfizer Investigational Site
city: Tampere
country: Finland
facility: Pfizer Investigational Site
city: Turku
country: Finland
facility: Pfizer Investigational Site
city: Garches
country: France
facility: Pfizer Investigational Site
city: Lyon Cedex 03
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Rennes Cedex 9
country: France
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Marburg
country: Germany
facility: Pfizer Investigational Site
city: Muelheim a.d. Ruhr
country: Germany
facility: Pfizer Investigational Site
city: Muenchen
country: Germany
facility: Pfizer Investigational Site
city: Rosenheim
country: Germany
facility: Pfizer Investigational Site
city: Holargos
country: Greece
facility: Pfizer Investigational Site
state: Athens
city: Epirus
country: Greece
facility: Pfizer Investigational Site
state: Ioannina
city: Rio
country: Greece
facility: Pfizer Investigational Site
state: Patras
city: Cefalu'
country: Italy
facility: Pfizer Investigational Site
state: Palermo
city: Firenze
country: Italy
facility: Pfizer Investigational Site
city: Latina
country: Italy
facility: Pfizer Investigational Site
city: Riga
country: Latvia
facility: Pfizer Investigational Site
city: Moelv
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Myslowice
country: Poland
facility: Pfizer Investigational Site
city: Poznan
country: Poland
facility: Pfizer Investigational Site
city: Szczecin
country: Poland
facility: Pfizer Investigational Site
city: Szczecin
country: Poland
facility: Pfizer Investigational Site
city: Szczecin
country: Poland
facility: Pfizer Investigational Site
city: Wroclaw
country: Poland
facility: Pfizer Investigational Site
city: Bratislava 37
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
city: Trencin
country: Slovakia
facility: Pfizer Investigational Site
city: Sabadell
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Manacor
country: Spain
facility: Pfizer Investigational Site
state: Palma de Mallorca
city: Aarau
country: Switzerland
facility: Pfizer Investigational Site
city: Zurich
country: Switzerland
facility: Pfizer Investigational Site
city: High Heaton
country: United Kingdom
facility: Pfizer Investigational Site
state: Newcastle upon Tyne
city: Taunton
country: United Kingdom
facility: Pfizer Investigational Site
state: Somerset
city: Leeds
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: