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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Prostatic Hyperplasia

Treatments: Drug: UK-369,003

Study type: Interventional

Funder types: Industry

Identifiers

NCT00408954

A3711045

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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27 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: UK-369,003

Drug: UK-369,003

UK-369,003

Active Comparator group

Treatment:

Drug: UK-369,003

Drug: UK-369,003