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Efficacy Study of VA106483 in Males With Nocturia.

Primary Purpose

Nocturia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

VA106483

About this trial

This is an interventional treatment trial for Nocturia focused on measuring VA106483, Nocturia, males, nocturnal voids, anti-diuretic, hyponatraemia

Eligibility Criteria

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

Inclusion Criteria:

Male subjects aged ≥18 years (no upper limit) with nocturia
Generally well (concomitant illness/conditions well controlled)
Serum sodium within the normal limits
Normal or not clinically significant prostate specific antigen levels
Able to comply with the requirements of the study
Provide written informed consent

Exclusion Criteria:

Prostatic cancer
Signs or symptoms of heart failure
Peripheral pitting oedema extending ≥10 cm above the ankle
Palpable bladder or pelvic mass on abdominal examination
Enuresis or night-time incontinence
Excessive nocturnal void frequency
Sleep disorders
Diabetes insipidus or uncontrolled diabetes mellitus
Presence of blood or glucose in the urine on urinalysis that is clinically significant
Urinary tract infection
Polydipsia
Syndrome of inappropriate antidiuretic hormone secretion
Body mass index ≥35
High calcium levels or low potassium levels
Other protocol defined eligibility criteria may apply

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

VA106483 1mg

VA106483 2mg

VA106483 4mg

Sugar pill

Arm Description

Outcomes

Primary Outcome Measures

Change in the mean number of nocturnal voids per night

Secondary Outcome Measures

Mean duration of first sleep period

Change in nocturia-related quality of life

Incidence and frequency of adverse events

Frequency of hyponatraemia

Change from baseline in safety laboratory parameters

Full Information

NCT ID

NCT01038843

First Posted

December 22, 2009

Last Updated

June 18, 2014

Sponsor

Vantia Ltd

1. Study Identification

Unique Protocol Identification Number

NCT01038843

Brief Title

Efficacy Study of VA106483 in Males With Nocturia.

Official Title

A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-titration Study to Determine the Efficacy and Safety of VA106483 in Male Subjects With Nocturia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

December 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vantia Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.

Detailed Description

Nocturia, defined as waking to urinate at least once per night between periods of sleep, is a common complaint which increases with age. VA106483 is a non-peptide drug VA106483 that is being developed for the treatment of nocturia in males. The purpose of this study is to investigate the effect of VA106483 on the number of times the subject needs to get up to urinate (nocturnal void) per night and to determine the effect on the time between the subject's bedtime and the time they first wake up to urinate.

6. Conditions and Keywords

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

Nocturia

Keywords

VA106483, Nocturia, males, nocturnal voids, anti-diuretic, hyponatraemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

152 (Actual)

8. Arms, Groups, and Interventions

Arm Title

VA106483 1mg

Arm Type

Experimental

Arm Title

VA106483 2mg

Arm Type

Experimental

Arm Title

VA106483 4mg

Arm Type

Experimental

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

VA106483

Intervention Description

Drug: VA106483 Once daily oral dose of 1 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 2 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 4 mg VA106483 or matching placebo for 28 days. Placebo: as above

Primary Outcome Measure Information:

Title

Change in the mean number of nocturnal voids per night

Time Frame

70 days

Secondary Outcome Measure Information:

Title

Mean duration of first sleep period

Time Frame

70 days

Title

Change in nocturia-related quality of life

Time Frame

70 days

Title

Incidence and frequency of adverse events

Time Frame

70 days

Title

Frequency of hyponatraemia

Time Frame

70 days

Title

Change from baseline in safety laboratory parameters

Time Frame

70 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male subjects aged ≥18 years (no upper limit) with nocturia Generally well (concomitant illness/conditions well controlled) Serum sodium within the normal limits Normal or not clinically significant prostate specific antigen levels Able to comply with the requirements of the study Provide written informed consent Exclusion Criteria: Prostatic cancer Signs or symptoms of heart failure Peripheral pitting oedema extending ≥10 cm above the ankle Palpable bladder or pelvic mass on abdominal examination Enuresis or night-time incontinence Excessive nocturnal void frequency Sleep disorders Diabetes insipidus or uncontrolled diabetes mellitus Presence of blood or glucose in the urine on urinalysis that is clinically significant Urinary tract infection Polydipsia Syndrome of inappropriate antidiuretic hormone secretion Body mass index ≥35 High calcium levels or low potassium levels Other protocol defined eligibility criteria may apply

Overall Study Officials: