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

Primary Purpose

Nocturia, Benign Prostatic Hypertrophy (BPH)

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

VA106483

About this trial

This is an interventional treatment trial for Nocturia focused on measuring VA106483, Nocturia, Benign Prostatic Hypertrophy, BPH, Elderly, Males, Nocturnal voids, Anti-diuretic

Eligibility Criteria

65 Years - undefined (Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Early Phase Clinical Unit, PAREXEL International GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Arm Label

VA106483 0.5 mg

VA106483 1 mg

VA106483 2 mg

VA106483 4 mg

Sugar pill

Arm Description

Outcomes

Primary Outcome Measures

Change in the mean nocturnal urine volumes

Secondary Outcome Measures

Change in the mean nocturnal void frequency

Change in mean time to first void

Change in frequency of daytime voids

Change in mean volume of daytime voids

Change in mean nocturnal urine osmolality

Change in mean daytime urine osmolality

Change in mean voided volumes

Full Information

NCT ID

NCT01330927

First Posted

March 30, 2011

Last Updated

August 1, 2011

Sponsor

Vantia Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01330927

Brief Title

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

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Vantia Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nocturia, Benign Prostatic Hypertrophy (BPH)

Keywords

VA106483, Nocturia, Benign Prostatic Hypertrophy, BPH, Elderly, Males, Nocturnal voids, Anti-diuretic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VA106483 0.5 mg

Arm Type

Experimental

Arm Title

VA106483 1 mg

Arm Type

Experimental

Arm Title

VA106483 2 mg

Arm Type

Experimental

Arm Title

VA106483 4 mg

Arm Type

Experimental

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

VA106483

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in the mean nocturnal urine volumes

Time Frame

20 days

Secondary Outcome Measure Information:

Title

Change in the mean nocturnal void frequency

Time Frame

20 days

Title

Change in mean time to first void

Time Frame

20 days

Title

Change in frequency of daytime voids

Time Frame

20 days

Title

Change in mean volume of daytime voids

Time Frame

20 days

Title

Change in mean nocturnal urine osmolality

Time Frame

20 days

Title

Change in mean daytime urine osmolality

Time Frame

20 days

Title

Change in mean voided volumes

Time Frame

20 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Georg Golor, PD Dr. med.

Organizational Affiliation

Parexel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Early Phase Clinical Unit, PAREXEL International GmbH

City

Berlin

ZIP/Postal Code

14050

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

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