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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00479505




Registration number
NCT00479505
Ethics application status
Date submitted
24/05/2007
Date registered
28/05/2007
Date last updated
23/03/2011

Titles & IDs
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).
Secondary ID [1] 0 0
A3711047
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urinary Bladder, Overactive 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UK-369,003
Treatment: Drugs - Placebo

Experimental: Active -

Placebo Comparator: Placebo -


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

Treatment: Drugs: Placebo
Placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
This is an estimation study with no primary endpoint. There are efficacy endpoints.
Timepoint [1] 0 0
12 Weeks
Secondary outcome [1] 0 0
Patient reported treatment impact questionnaire.
Timepoint [1] 0 0
12 Weeks
Secondary outcome [2] 0 0
Lower urinary tract symptoms diary.
Timepoint [2] 0 0
12 Weeks
Secondary outcome [3] 0 0
International prostate symptom score questionnaire.
Timepoint [3] 0 0
12 Weeks
Secondary outcome [4] 0 0
OAB-q short form questionnaire.
Timepoint [4] 0 0
12 Weeks
Secondary outcome [5] 0 0
Patient perception of bladder control questionnaire.
Timepoint [5] 0 0
12 Weeks
Secondary outcome [6] 0 0
International index of erectile function questionnaire.
Timepoint [6] 0 0
12 Weeks
Secondary outcome [7] 0 0
International consultation on incontinence questionnaire.
Timepoint [7] 0 0
12 Weeks
Secondary outcome [8] 0 0
Quality of erection questionnaire.
Timepoint [8] 0 0
12 Weeks

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Neurological diseases known to affect bladder function.

- Urinary tract infection.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Miranda
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Kippa Ring
Recruitment postcode(s) [1] 0 0
2228 - Miranda
Recruitment postcode(s) [2] 0 0
4021 - Kippa Ring
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
Ontario
Country [3] 0 0
Chile
State/province [3] 0 0
RM
Country [4] 0 0
Chile
State/province [4] 0 0
VI Región
Country [5] 0 0
Colombia
State/province [5] 0 0
Antioquia
Country [6] 0 0
Colombia
State/province [6] 0 0
Cundinamarca
Country [7] 0 0
Finland
State/province [7] 0 0
Helsinki
Country [8] 0 0
Finland
State/province [8] 0 0
Kouvola
Country [9] 0 0
Finland
State/province [9] 0 0
Oulu
Country [10] 0 0
Finland
State/province [10] 0 0
Tampere
Country [11] 0 0
Finland
State/province [11] 0 0
Turku
Country [12] 0 0
France
State/province [12] 0 0
Garches
Country [13] 0 0
France
State/province [13] 0 0
Lyon Cedex 03
Country [14] 0 0
France
State/province [14] 0 0
Montpellier
Country [15] 0 0
France
State/province [15] 0 0
Paris
Country [16] 0 0
France
State/province [16] 0 0
Rennes Cedex 9
Country [17] 0 0
Germany
State/province [17] 0 0
Frankfurt
Country [18] 0 0
Germany
State/province [18] 0 0
Marburg
Country [19] 0 0
Germany
State/province [19] 0 0
Muelheim a.d. Ruhr
Country [20] 0 0
Germany
State/province [20] 0 0
Muenchen
Country [21] 0 0
Germany
State/province [21] 0 0
Rosenheim
Country [22] 0 0
Greece
State/province [22] 0 0
Athens
Country [23] 0 0
Greece
State/province [23] 0 0
Ioannina
Country [24] 0 0
Greece
State/province [24] 0 0
Patras
Country [25] 0 0
Italy
State/province [25] 0 0
Palermo
Country [26] 0 0
Italy
State/province [26] 0 0
Firenze
Country [27] 0 0
Italy
State/province [27] 0 0
Latina
Country [28] 0 0
Latvia
State/province [28] 0 0
Riga
Country [29] 0 0
Norway
State/province [29] 0 0
Moelv
Country [30] 0 0
Norway
State/province [30] 0 0
Oslo
Country [31] 0 0
Poland
State/province [31] 0 0
Myslowice
Country [32] 0 0
Poland
State/province [32] 0 0
Poznan
Country [33] 0 0
Poland
State/province [33] 0 0
Szczecin
Country [34] 0 0
Poland
State/province [34] 0 0
Wroclaw
Country [35] 0 0
Slovakia
State/province [35] 0 0
Bratislava 37
Country [36] 0 0
Slovakia
State/province [36] 0 0
Kosice
Country [37] 0 0
Slovakia
State/province [37] 0 0
Martin
Country [38] 0 0
Slovakia
State/province [38] 0 0
Trencin
Country [39] 0 0
Spain
State/province [39] 0 0
Barcelona
Country [40] 0 0
Spain
State/province [40] 0 0
Palma de Mallorca
Country [41] 0 0
Switzerland
State/province [41] 0 0
Aarau
Country [42] 0 0
Switzerland
State/province [42] 0 0
Zurich
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Newcastle upon Tyne
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Somerset
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Leeds

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00479505
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications