Urinary Bladder, OveractivePhase 2NCT00479505
Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder
A Phase 2 study testing UK-369,003 in people with Urinary Bladder, Overactive, run by Pfizer at 52 sites in 16 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Bladder, Overactive
- What is being tested?
- UK-369,003
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 275 participants
- Where
- 52 sitesin 16 countries
- Study dates
- Jun 2007to Jun 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Neurological diseases known to affect bladder function.
- Urinary tract infection.
Trial locations and contacts
52 sites in 16 countries.
52 sites in 16 countries
Poland6 sites
Pfizer Investigational Site
Mysłowice, 41-400
Pfizer Investigational Site
Poznan, 61-485
Pfizer Investigational Site
Szczecin, 70-111
Pfizer Investigational Site
Szczecin, 70-451
Pfizer Investigational Site
Szczecin, 70-467
Pfizer Investigational Site
Wroclaw, 53-020
Finland5 sites
Pfizer Investigational Site
Helsinki, 00100
Pfizer Investigational Site
Kouvola, 45200
Pfizer Investigational Site
Oulu, 90100
Pfizer Investigational Site
Tampere, 33100
Pfizer Investigational Site
Turku, 20100
France5 sites
Pfizer Investigational Site
Garches, 92380
Pfizer Investigational Site
Lyon, 69437
Pfizer Investigational Site
Montpellier, 34090
Pfizer Investigational Site
Paris, 75020
Pfizer Investigational Site
Rennes, 35033
Germany5 sites
Pfizer Investigational Site
Frankfurt, 65929
Pfizer Investigational Site
Marburg, 35039
Pfizer Investigational Site
Muelheim A.d. Ruhr, 45468
Pfizer Investigational Site
München, 81925
Pfizer Investigational Site
Rosenheim, 83022
Canada4 sites
Pfizer Investigational Site
Barrie, Ontario, L4M 7G1
Pfizer Investigational Site
Kitchener, Ontario, N2N 2B9
Pfizer Investigational Site
Toronto, Ontario, M6A 3B5
Pfizer Investigational Site
Victoria, British Columbia, V8T 5G1
Slovakia4 sites
Pfizer Investigational Site
Bratislava, Slovakia, 833 31
Pfizer Investigational Site
Košice, 040 11
Pfizer Investigational Site
Martin, Slovakia, 036 59
Pfizer Investigational Site
Trenčín, Slovakia, 911 01
Chile3 sites
Pfizer Investigational Site
Rancagua, Región del Libertador General Bernardo O’Higgins, 2820945
Pfizer Investigational Site
Santiago, RM, 8380419
Pfizer Investigational Site
Santiago, RM, 8380456
Greece3 sites
Pfizer Investigational Site
Cholargós, Athens, 15562
Pfizer Investigational Site
Epirus, Ioannina, 45500
Pfizer Investigational Site
Rio, Patras, 26500
Italy3 sites
Pfizer Investigational Site
Cefalù, Palermo, 90015
Pfizer Investigational Site
Florence, 50139
Pfizer Investigational Site
Latina, 04100
United Kingdom3 sites
Pfizer Investigational Site
High Heaton, Newcastle upon Tyne, NE7 7DN
Pfizer Investigational Site
Leeds, LS9 7TF
Pfizer Investigational Site
Taunton, Somerset, TA1 5DA
Australia2 sites
Pfizer Investigational Site
Kippa-Ring, Queensland, 4021
Pfizer Investigational Site
Miranda, New South Wales, 2228
Colombia2 sites
Pfizer Investigational Site
Bogota, Cundinamarca
Pfizer Investigational Site
Medellín, Antioquia, 0
Norway2 sites
Pfizer Investigational Site
Moelv, N-2390
Pfizer Investigational Site
Oslo, NO-0257
Spain2 sites
Pfizer Investigational Site
Manacor, Palma de Mallorca, 07500
Pfizer Investigational Site
Sabadell, Barcelona, 08208
Switzerland2 sites
Pfizer Investigational Site
Aarau, 5001
Pfizer Investigational Site
Zurich, 8091
About this study
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).
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.
- Conditions
- Urinary Bladder, Overactive
- Being tested
- UK-369,003, Placebo
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UK-369,003Drug
UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Drug: UK-369,003 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
This is an estimation study with no primary endpoint. There are efficacy endpoints.
Measured: 12 Weeks
Secondary outcomes (8)
Patient reported treatment impact questionnaire.
Measured: 12 Weeks
Lower urinary tract symptoms diary.
Measured: 12 Weeks
International prostate symptom score questionnaire.
Measured: 12 Weeks
OAB-q short form questionnaire.
Measured: 12 Weeks
Patient perception of bladder control questionnaire.
Measured: 12 Weeks
International index of erectile function questionnaire.
Measured: 12 Weeks
International consultation on incontinence questionnaire.
Measured: 12 Weeks
Quality of erection questionnaire.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder, OveractiveStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00479505
- Sponsor's protocol ID
- A3711047
- Status last verified
- Mar 2011
- First submitted
- 24 May 2007
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT00479505
- Acronym / sponsor ID
- A3711047
- Conditions
- Urinary Bladder, Overactive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 28 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Drug: UK-369,003 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Neurological diseases known to affect bladder function.
- Urinary tract infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UK-369,003UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo. | Drug | Active |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
This is an estimation study with no primary endpoint. There are efficacy endpoints.
Time frame: 12 Weeks
8 secondary outcomes
Patient reported treatment impact questionnaire.
Time frame: 12 Weeks
Lower urinary tract symptoms diary.
Time frame: 12 Weeks
International prostate symptom score questionnaire.
Time frame: 12 Weeks
OAB-q short form questionnaire.
Time frame: 12 Weeks
Patient perception of bladder control questionnaire.
Time frame: 12 Weeks
International index of erectile function questionnaire.
Time frame: 12 Weeks
International consultation on incontinence questionnaire.
Time frame: 12 Weeks
Quality of erection questionnaire.
Time frame: 12 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
52 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UK-369,003 in people with Urinary Bladder, Overactive, run by Pfizer at 52 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Poland, Finland, France, Germany, Canada and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
This is an estimation study with no primary endpoint. There are efficacy endpoints. (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2011.