Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder

Urinary Bladder, Overactive Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479505
• Other study ID #: A3711047
• Status: Completed
• Phase: Phase 2
• First received: May 24, 2007
• Last updated: March 11, 2011
• Start date: June 2007
• Est. completion date: June 2008

Study information

• Verified date: March 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 275
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lower Urinary Tract Symptoms
• Urinary Bladder, Overactive

Intervention

Drug:
• UK-369,003
UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.
• Placebo
Placebo

Locations

Country	Name	City	State
Australia	Pfizer Investigational Site	Kippa Ring	Queensland
Australia	Pfizer Investigational Site	Miranda	New South Wales
Canada	Pfizer Investigational Site	Barrie	Ontario
Canada	Pfizer Investigational Site	Kitchener	Ontario
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Victoria	British Columbia
Chile	Pfizer Investigational Site	Rancagua	VI Región
Chile	Pfizer Investigational Site	Santiago	RM
Chile	Pfizer Investigational Site	Santiago	RM
Colombia	Pfizer Investigational Site	Bogota	Cundinamarca
Colombia	Pfizer Investigational Site	Medellin	Antioquia
Finland	Pfizer Investigational Site	Helsinki
Finland	Pfizer Investigational Site	Kouvola
Finland	Pfizer Investigational Site	Oulu
Finland	Pfizer Investigational Site	Tampere
Finland	Pfizer Investigational Site	Turku
France	Pfizer Investigational Site	Garches
France	Pfizer Investigational Site	Lyon Cedex 03
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Paris
France	Pfizer Investigational Site	Rennes Cedex 9
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Marburg
Germany	Pfizer Investigational Site	Muelheim a.d. Ruhr
Germany	Pfizer Investigational Site	Muenchen
Germany	Pfizer Investigational Site	Rosenheim
Greece	Pfizer Investigational Site	Epirus	Ioannina
Greece	Pfizer Investigational Site	Holargos	Athens
Greece	Pfizer Investigational Site	Rio	Patras
Italy	Pfizer Investigational Site	Cefalu'	Palermo
Italy	Pfizer Investigational Site	Firenze
Italy	Pfizer Investigational Site	Latina
Latvia	Pfizer Investigational Site	Riga
Norway	Pfizer Investigational Site	Moelv
Norway	Pfizer Investigational Site	Oslo
Poland	Pfizer Investigational Site	Myslowice
Poland	Pfizer Investigational Site	Poznan
Poland	Pfizer Investigational Site	Szczecin
Poland	Pfizer Investigational Site	Szczecin
Poland	Pfizer Investigational Site	Szczecin
Poland	Pfizer Investigational Site	Wroclaw
Slovakia	Pfizer Investigational Site	Bratislava 37
Slovakia	Pfizer Investigational Site	Kosice
Slovakia	Pfizer Investigational Site	Martin
Slovakia	Pfizer Investigational Site	Trencin
Spain	Pfizer Investigational Site	Manacor	Palma de Mallorca
Spain	Pfizer Investigational Site	Sabadell	Barcelona
Switzerland	Pfizer Investigational Site	Aarau
Switzerland	Pfizer Investigational Site	Zurich
United Kingdom	Pfizer Investigational Site	High Heaton	Newcastle upon Tyne
United Kingdom	Pfizer Investigational Site	Leeds
United Kingdom	Pfizer Investigational Site	Taunton	Somerset

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Australia,  Canada,  Chile,  Colombia,  Finland,  France,  Germany,  Greece,  Italy,  Latvia,  Norway,  Poland,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	This is an estimation study with no primary endpoint. There are efficacy endpoints.		12 Weeks	No
Secondary	Patient reported treatment impact questionnaire.		12 Weeks	No
Secondary	Lower urinary tract symptoms diary.		12 Weeks	No
Secondary	International prostate symptom score questionnaire.		12 Weeks	No
Secondary	OAB-q short form questionnaire.		12 Weeks	No
Secondary	Patient perception of bladder control questionnaire.		12 Weeks	No
Secondary	International index of erectile function questionnaire.		12 Weeks	No
Secondary	International consultation on incontinence questionnaire.		12 Weeks	No
Secondary	Quality of erection questionnaire.		12 Weeks	No

External Links

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