Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Sex
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
1/06/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2008
Sample size
Target
275
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00479505