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

Phase 2

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: UK-369,003

• Registration Number: NCT00408954
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2006-12-06
• Study First Submitted QC: 2006-12-07
• Study First Posted: 2006-12-08
• Study Start: 2007-03
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Disposition First Submitted: 2009-03-24
• Status Verified: 2010-11
• Disposition First Submitted QC: 2010-11-12
• Last Update Submitted: 2010-11-12
• Disposition First Posted: 2010-11-23
• Last Update Posted: 2010-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 27

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	UK-369,003	-
UK-369,003	UK-369,003	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Volume at first unstable contraction	Duration of study
Maximum flow rate (Qmax)	Duration of study
Cystometric capacity	Duration of study
Post void residual volume (PVR)	Duration of study
Average flow rate (Qave)	Duration of study
Average detrusor pressure during micturition	Duration of study
Detrusor pressure at maximum flow rate (PdetQmax)	Duration of study
Bladder outlet obstruction index (BOOI)	Duration of study
Bladder contractility index (BCI)	Duration of study
Bladder voiding efficiency (BE)	Duration of study
Frequency of unstable contractions	Duration of study
International Prostate Symptom Score (IPSS)	Duration of study
Mean amplitude of unstable contractions	Duration of study
Patient Reported Treatment Impact (PRTI)	Duration of study

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇰 Trencin, Slovakia