Nocturia Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled, Five-way Cross-over Dose Response Study to Determine the Effect of VA106483 on Nocturnal Urine Volume in Elderly Male Subjects With Nocturia and Benign Prostatic Hypertrophy (BPH)
The purpose of this study is to establish the dose response relationship of VA106483 and nocturnal urine volumes in a population of elderly male subjects with Benign Prostatic Hypertrophy (BPH) who are likely to present with nocturia.
VA106483 is a selective vasopressin V2-receptor (V2-receptor) agonist that is being
developed for the treatment of nocturia.
The antidiuretic effect of V2-receptor stimulation in the kidneys is well established
through the use of the peptide agonist, desmopressin, which shows clinical benefit in
diabetes insipidus, primary nocturnal enuresis and nocturia.
Nocturia, defined as waking to void at least once per night between periods of sleep, is a
common complaint and shows an age-dependent increase in both prevalence and severity (number
of nocturnal voids). It is the most bothersome symptom of benign prostatic hypertrophy and
has been linked to an age-dependent loss in circadian release of endogenous nocturnal
vasopressin and consequent over production of urine at night (nocturnal polyuria).
Correlation between nocturnal urine volume and nocturnal void frequency has been
demonstrated in previous studies of V2-receptor agonists.
The purpose of this study is to determine the dose response relationship of VA106483 and
nocturnal urine volumes.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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