Clinical trial NCT01330927: Dose Response Study of VA106483 in Males With Nocturia and Benign Prostatic Hypertrophy (BPH)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Nocturia
Benign Prostatic Hypertrophy (BPH)
Keywords: VA106483
Nocturia
Benign Prostatic Hypertrophy
BPH
Elderly
Males
Nocturnal voids
Anti-diuretic
Lead sponsor: Vantia Ltd
Sponsor class: INDUSTRY
First posted: 2011-04-07
Enrollment: 30
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Males aged 65 years old and above with history of nocturia and benign prostatic hypertrophy (BPH)

Exclusion Criteria:

* Administration of any Investigational Medicinal Product (IMP) within 10 weeks before entry to the study
* Any clinically significant concomitant medical disease, condition or abnormal laboratory test result
* Other protocol defined eligibility criteria may apply

Primary outcomes:
measure: Change in the mean nocturnal urine volumes
timeFrame: 20 days
Secondary outcomes:
measure: Change in the mean nocturnal void frequency
timeFrame: 20 days
measure: Change in mean time to first void
timeFrame: 20 days
measure: Change in frequency of daytime voids
timeFrame: 20 days
measure: Change in mean volume of daytime voids
timeFrame: 20 days
measure: Change in mean nocturnal urine osmolality
timeFrame: 20 days
measure: Change in mean daytime urine osmolality
timeFrame: 20 days
measure: Change in mean voided volumes
timeFrame: 20 days
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Early Phase Clinical Unit, PAREXEL International GmbH
Study officials:
affiliation: Parexel
name: Georg Golor, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: