NCT01330927

Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Vantia Ltd · Industry
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Nocturia
• Benign Prostatic Hypertrophy (BPH)

Interventions

Type	Name	Description
DRUG	VA106483	Once daily oral dose of placebo for 2 nights Once daily oral dose of 0.5 mg VA106483 for 2 nights Once daily oral dose of 1 mg VA106483 for 2 nights Once daily oral dose of 2 mg VA106483 for 2 nights Once daily oral dose of 4 mg VA106483 for 2 nights Placebo: as above

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2011-04-07
• Last updated: 2011-08-02

Locations

1 site across 1 country: Germany