Clinical trial NCT00408954: Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Hyperplasia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2006-12-08
Enrollment: 27
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* prostate cancer
* Post-void residual urine volume \>200 ml
* Documented UTI
* History of relevant urological surgery

Primary outcomes:
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.
timeFrame: Duration of study
Secondary outcomes:
measure: Maximum flow rate (Qmax)
timeFrame: Duration of study
measure: Cystometric capacity
timeFrame: Duration of study
measure: Post void residual volume (PVR)
timeFrame: Duration of study
measure: Average flow rate (Qave)
timeFrame: Duration of study
measure: Volume at first unstable contraction
timeFrame: Duration of study
measure: Average detrusor pressure during micturition
timeFrame: Duration of study
measure: Detrusor pressure at maximum flow rate (PdetQmax)
timeFrame: Duration of study
measure: Bladder outlet obstruction index (BOOI)
timeFrame: Duration of study
measure: Bladder contractility index (BCI)
timeFrame: Duration of study
measure: Bladder voiding efficiency (BE)
timeFrame: Duration of study
measure: Frequency of unstable contractions
timeFrame: Duration of study
measure: International Prostate Symptom Score (IPSS)
timeFrame: Duration of study
measure: Mean amplitude of unstable contractions
timeFrame: Duration of study
measure: Patient Reported Treatment Impact (PRTI)
timeFrame: Duration of study
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Pfizer Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: Pfizer Investigational Site
city: Olomouc
country: Czech Republic
facility: Pfizer Investigational Site
city: Usti nad Labem
country: Czech Republic
facility: Pfizer Investigational Site
city: Amsterdam
country: Netherlands
facility: Pfizer Investigational Site
city: Nijmegen
country: Netherlands
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Martin
country: Slovakia
facility: Pfizer Investigational Site
city: Trencin
country: Slovakia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: