Prostatic HyperplasiaPhase 2NCT00408954
Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms
A Phase 2 study testing UK-369,003 in people with Prostatic Hyperplasia, run by Pfizer at 11 sites in 3 countries.
Trial summary
This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- UK-369,003
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Mar 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13.
- Clinical diagnosis of BPH
- Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml
- Urodynamically defined bladder outlet obstruction
Who cannot join
- prostate cancer
- Post-void residual urine volume >200 ml
- Documented UTI
- History of relevant urological surgery
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Slovakia5 sites
Pfizer Investigational Site
Bratislava, Slovakia, 833 05
Pfizer Investigational Site
Košice, 040 11
Pfizer Investigational Site
Košice, 041 90
Pfizer Investigational Site
Martin, Slovakia, 036 59
Pfizer Investigational Site
Trenčín, Slovakia, 911 01
Czechia4 sites
Pfizer Investigational Site
Brno, 612 00
Pfizer Investigational Site
Hradec Králové, 500 02
Pfizer Investigational Site
Olomouc, 775 20
Pfizer Investigational Site
Ústí nad Labem, 401 13
Netherlands2 sites
Pfizer Investigational Site
Amsterdam, 1081 HV
Pfizer Investigational Site
Nijmegen, 6525 GA
About this study
Official title: A Multi Center Randomized Cross Over Double Blind Third Party Open Placebo Controlled Pilot Study to Assess the Urodynamic Effects of Modified Release UK-369,003 in Men With Lower Urinary Tract Symptoms.
This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
- Conditions
- Prostatic Hyperplasia
- Being tested
- UK-369,003
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UK-369,003Drug
100 mg MR tablet once daily for 2 weeks
UK-369,003Drug
UK-369,003-100 mg MR formulation for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: UK-369,003 |
| UK-369,003 | Active comparator | Not described Receives: Drug: UK-369,003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
Measured: Duration of study
Secondary outcomes (14)
Maximum flow rate (Qmax)
Measured: Duration of study
Cystometric capacity
Measured: Duration of study
Post void residual volume (PVR)
Measured: Duration of study
Average flow rate (Qave)
Measured: Duration of study
Volume at first unstable contraction
Measured: Duration of study
Average detrusor pressure during micturition
Measured: Duration of study
Detrusor pressure at maximum flow rate (PdetQmax)
Measured: Duration of study
Bladder outlet obstruction index (BOOI)
Measured: Duration of study
Bladder contractility index (BCI)
Measured: Duration of study
Bladder voiding efficiency (BE)
Measured: Duration of study
Frequency of unstable contractions
Measured: Duration of study
International Prostate Symptom Score (IPSS)
Measured: Duration of study
Mean amplitude of unstable contractions
Measured: Duration of study
Patient Reported Treatment Impact (PRTI)
Measured: Duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startMar 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 Prostatic HyperplasiaStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 27 participants (actual)
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
- NCT00408954
- Sponsor's protocol ID
- A3711045
- Status last verified
- Nov 2010
- First submitted
- 6 Dec 2006
- Last updated
- 23 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center Randomized Cross Over Double Blind Third Party Open Placebo Controlled Pilot Study to Assess the Urodynamic Effects of Modified Release UK-369,003 in Men With Lower Urinary Tract Symptoms.
- ClinicalTrials.gov ID
- NCT00408954
- Acronym / sponsor ID
- A3711045
- Conditions
- Prostatic Hyperplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 8 Dec 2006 (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 pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: UK-369,003 |
| UK-369,003 | Active comparator | Drug: UK-369,003 |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13.
- Clinical diagnosis of BPH
- Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml
- Urodynamically defined bladder outlet obstruction
Key exclusion criteria (4 listed)
- prostate cancer
- Post-void residual urine volume >200 ml
- Documented UTI
- History of relevant urological surgery
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-369,003100 mg MR tablet once daily for 2 weeks | Drug | UK-369,003 |
| UK-369,003UK-369,003-100 mg MR formulation for 2 weeks | Drug | Placebo |
Primary outcome
There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.
Time frame: Duration of study
14 secondary outcomes
Maximum flow rate (Qmax)
Time frame: Duration of study
Cystometric capacity
Time frame: Duration of study
Post void residual volume (PVR)
Time frame: Duration of study
Average flow rate (Qave)
Time frame: Duration of study
Volume at first unstable contraction
Time frame: Duration of study
Average detrusor pressure during micturition
Time frame: Duration of study
Detrusor pressure at maximum flow rate (PdetQmax)
Time frame: Duration of study
Bladder outlet obstruction index (BOOI)
Time frame: Duration of study
Bladder contractility index (BCI)
Time frame: Duration of study
Bladder voiding efficiency (BE)
Time frame: Duration of study
Frequency of unstable contractions
Time frame: Duration of study
International Prostate Symptom Score (IPSS)
Time frame: Duration of study
Mean amplitude of unstable contractions
Time frame: Duration of study
Patient Reported Treatment Impact (PRTI)
Time frame: Duration of study
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 Nov 2010.
- 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
11 sites in 3 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 Prostatic Hyperplasia, run by Pfizer at 11 sites in 3 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 4 inclusion and 4 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 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Slovakia, Czechia, Netherlands. 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?
There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms. (time frame: Duration of study). 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 Nov 2010.