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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01330927
• Other study ID #: 483-008
• Status: Completed
• Phase: Phase 1
• First received: March 30, 2011
• Last updated: August 1, 2011
• Start date: March 2011
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Vantia Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Prostatic Hypertrophy (BPH)
• Hypertrophy
• Nocturia
• Prostatic Hyperplasia

Intervention

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

Locations

Country	Name	City	State
Germany	Early Phase Clinical Unit, PAREXEL International GmbH	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Vantia Ltd

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the mean nocturnal urine volumes		20 days	No
Secondary	Change in the mean nocturnal void frequency		20 days	No
Secondary	Change in mean time to first void		20 days	No
Secondary	Change in frequency of daytime voids		20 days	No
Secondary	Change in mean volume of daytime voids		20 days	No
Secondary	Change in mean nocturnal urine osmolality		20 days	No
Secondary	Change in mean daytime urine osmolality		20 days	No
Secondary	Change in mean voided volumes		20 days	No