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NCT00408954 Clinical Trial

Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms

Prostatic Hyperplasia Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00408954
Other study ID # A3711045
Secondary ID
Status Completed
Phase Phase 2
First received December 6, 2006
Last updated November 12, 2010
Start date March 2007
Est. completion date June 2008

Study information
Verified date November 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Slovakia: State Institute for Drug Control
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date June 2008
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Male
Age group 40 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• UK-369,003
100 mg MR tablet once daily for 2 weeks
• UK-369,003
UK-369,003-100 mg MR formulation for 2 weeks

Locations
Country Name City State
Czech Republic Pfizer Investigational Site Brno
Czech Republic Pfizer Investigational Site Hradec Kralove
Czech Republic Pfizer Investigational Site Olomouc
Czech Republic Pfizer Investigational Site Usti nad Labem
Netherlands Pfizer Investigational Site Amsterdam
Netherlands Pfizer Investigational Site Nijmegen
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Kosice
Slovakia Pfizer Investigational Site Kosice
Slovakia Pfizer Investigational Site Martin
Slovakia Pfizer Investigational Site Trencin

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Czech Republic,  Netherlands,  Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. Duration of study No
Secondary Maximum flow rate (Qmax) Duration of study No
Secondary Cystometric capacity Duration of study No
Secondary Post void residual volume (PVR) Duration of study No
Secondary Average flow rate (Qave) Duration of study No
Secondary Volume at first unstable contraction Duration of study No
Secondary Average detrusor pressure during micturition Duration of study No
Secondary Detrusor pressure at maximum flow rate (PdetQmax) Duration of study No
Secondary Bladder outlet obstruction index (BOOI) Duration of study No
Secondary Bladder contractility index (BCI) Duration of study No
Secondary Bladder voiding efficiency (BE) Duration of study No
Secondary Frequency of unstable contractions Duration of study No
Secondary International Prostate Symptom Score (IPSS) Duration of study No
Secondary Mean amplitude of unstable contractions Duration of study No
Secondary Patient Reported Treatment Impact (PRTI) Duration of study No
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