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

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).

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00479505

Enrollment

275

Registered

2007-05-28

Start date

2007-06-30

Completion date

2008-06-30

Last updated

2011-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder, Overactive

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.

Interventions

DRUGUK-369,003

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

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
This is an estimation study with no primary endpoint. There are efficacy endpoints.	12 Weeks

Secondary

Measure	Time frame
Lower urinary tract symptoms diary.	12 Weeks
International prostate symptom score questionnaire.	12 Weeks
OAB-q short form questionnaire.	12 Weeks
Patient reported treatment impact questionnaire.	12 Weeks
International index of erectile function questionnaire.	12 Weeks
International consultation on incontinence questionnaire.	12 Weeks
Quality of erection questionnaire.	12 Weeks
Patient perception of bladder control questionnaire.	12 Weeks

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026