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

Phase 1

Completed

• Conditions: Nocturia; Benign Prostatic Hypertrophy (BPH)
• Interventions: Drug: VA106483

• Registration Number: NCT01330927
• Lead Sponsor: Vantia Ltd

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-30
• Study First Submitted QC: 2011-04-05
• Study First Posted: 2011-04-07
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-01
• Last Update Posted: 2011-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
VA106483 0.5 mg	VA106483	-
VA106483 1 mg	VA106483	-
VA106483 2 mg	VA106483	-
VA106483 4 mg	VA106483	-
Sugar pill	VA106483	-

Primary Outcome Measures

Name	Time	Method
Change in the mean nocturnal urine volumes	20 days

Secondary Outcome Measures

Name	Time	Method
Change in the mean nocturnal void frequency	20 days
Change in mean time to first void	20 days
Change in frequency of daytime voids	20 days
Change in mean volume of daytime voids	20 days
Change in mean nocturnal urine osmolality	20 days
Change in mean daytime urine osmolality	20 days
Change in mean voided volumes	20 days

Trial Locations

Locations (1)

Early Phase Clinical Unit, PAREXEL International GmbH; 🇩🇪 Berlin, Germany