search
Back to results

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

Primary Purpose

Urinary Bladder, Overactive

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
UK-369,003
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active

Placebo

Arm Description

Outcomes

Primary Outcome Measures

This is an estimation study with no primary endpoint. There are efficacy endpoints.

Secondary Outcome Measures

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

Full Information

First Posted
May 24, 2007
Last Updated
March 11, 2011
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00479505
Brief Title
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

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder, Overactive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
275 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
UK-369,003
Intervention Description
UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
This is an estimation study with no primary endpoint. There are efficacy endpoints.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Patient reported treatment impact questionnaire.
Time Frame
12 Weeks
Title
Lower urinary tract symptoms diary.
Time Frame
12 Weeks
Title
International prostate symptom score questionnaire.
Time Frame
12 Weeks
Title
OAB-q short form questionnaire.
Time Frame
12 Weeks
Title
Patient perception of bladder control questionnaire.
Time Frame
12 Weeks
Title
International index of erectile function questionnaire.
Time Frame
12 Weeks
Title
International consultation on incontinence questionnaire.
Time Frame
12 Weeks
Title
Quality of erection questionnaire.
Time Frame
12 Weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Miranda
State/Province
New South Wales
ZIP/Postal Code
2228
Country
Australia
Facility Name
Pfizer Investigational Site
City
Kippa Ring
State/Province
Queensland
ZIP/Postal Code
4021
Country
Australia
Facility Name
Pfizer Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8T 5G1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 2B9
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 3B5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Santiago
State/Province
RM
ZIP/Postal Code
8380419
Country
Chile
Facility Name
Pfizer Investigational Site
City
Santiago
State/Province
RM
ZIP/Postal Code
8380456
Country
Chile
Facility Name
Pfizer Investigational Site
City
Rancagua
State/Province
VI Región
ZIP/Postal Code
2820945
Country
Chile
Facility Name
Pfizer Investigational Site
City
Medellin
State/Province
Antioquia
ZIP/Postal Code
0
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Helsinki
ZIP/Postal Code
00100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Kouvola
ZIP/Postal Code
45200
Country
Finland
Facility Name
Pfizer Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Turku
ZIP/Postal Code
20100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Pfizer Investigational Site
City
Lyon Cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
Pfizer Investigational Site
City
Montpellier
ZIP/Postal Code
34090
Country
France
Facility Name
Pfizer Investigational Site
City
Paris
ZIP/Postal Code
75020
Country
France
Facility Name
Pfizer Investigational Site
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Pfizer Investigational Site
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Pfizer Investigational Site
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muelheim a.d. Ruhr
ZIP/Postal Code
45468
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81925
Country
Germany
Facility Name
Pfizer Investigational Site
City
Rosenheim
ZIP/Postal Code
83022
Country
Germany
Facility Name
Pfizer Investigational Site
City
Holargos
State/Province
Athens
ZIP/Postal Code
15562
Country
Greece
Facility Name
Pfizer Investigational Site
City
Epirus
State/Province
Ioannina
ZIP/Postal Code
45500
Country
Greece
Facility Name
Pfizer Investigational Site
City
Rio
State/Province
Patras
ZIP/Postal Code
26500
Country
Greece
Facility Name
Pfizer Investigational Site
City
Cefalu'
State/Province
Palermo
ZIP/Postal Code
90015
Country
Italy
Facility Name
Pfizer Investigational Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Pfizer Investigational Site
City
Latina
ZIP/Postal Code
04100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Riga
ZIP/Postal Code
LV 1010
Country
Latvia
Facility Name
Pfizer Investigational Site
City
Moelv
ZIP/Postal Code
N-2390
Country
Norway
Facility Name
Pfizer Investigational Site
City
Oslo
ZIP/Postal Code
NO-0257
Country
Norway
Facility Name
Pfizer Investigational Site
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Pfizer Investigational Site
City
Poznan
ZIP/Postal Code
61-485
Country
Poland
Facility Name
Pfizer Investigational Site
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Pfizer Investigational Site
City
Szczecin
ZIP/Postal Code
70-451
Country
Poland
Facility Name
Pfizer Investigational Site
City
Szczecin
ZIP/Postal Code
70-467
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wroclaw
ZIP/Postal Code
53-020
Country
Poland
Facility Name
Pfizer Investigational Site
City
Bratislava 37
ZIP/Postal Code
833 31
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Kosice
ZIP/Postal Code
040 11
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Martin
ZIP/Postal Code
036 59
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Pfizer Investigational Site
City
Manacor
State/Province
Palma de Mallorca
ZIP/Postal Code
07500
Country
Spain
Facility Name
Pfizer Investigational Site
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
High Heaton
State/Province
Newcastle upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3711047&StudyName=Study%20The%20Effects%20Of%20Different%20Doses%20Of%20UK-369%2C003%20In%20Men%20With%20Overactive%20Bladder.
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs