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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00479505
• Date of registration: 24/05/2007
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder
• Scientific 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).
• Date of first enrolment: June 2007
• Target sample size: 275
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00479505
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Urinary Bladder, Overactive

Intervention(s)

Drug: Placebo

Drug: UK-369,003

Primary Outcome(s)

This is an estimation study with no primary endpoint. There are efficacy endpoints. [Time Frame: 12 Weeks]

Secondary Outcome(s)

International index of erectile function questionnaire. [Time Frame: 12 Weeks]

OAB-q short form questionnaire. [Time Frame: 12 Weeks]

International consultation on incontinence questionnaire. [Time Frame: 12 Weeks]

International prostate symptom score questionnaire. [Time Frame: 12 Weeks]

Lower urinary tract symptoms diary. [Time Frame: 12 Weeks]

Patient reported treatment impact questionnaire. [Time Frame: 12 Weeks]

Patient perception of bladder control questionnaire. [Time Frame: 12 Weeks]

Quality of erection questionnaire. [Time Frame: 12 Weeks]

Secondary ID(s)

A3711047

Source(s) of Monetary Support

Please refer to primary and secondary sponsors