Efficacy Study of VA106483 in Males With Nocturia. - Full Text View

Sponsor:	Vantia Ltd
Information provided by:	Vantia Ltd
ClinicalTrials.gov Identifier:	NCT01038843

Purpose

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

Condition	Intervention	Phase
Nocturia	Drug: VA106483	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Further study details as provided by Vantia Ltd:

Primary Outcome Measures:

Change in the mean number of nocturnal voids per night [ Time Frame: 70 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean duration of first sleep period [ Time Frame: 70 days ] [ Designated as safety issue: No ]
Change in nocturia-related quality of life [ Time Frame: 70 days ] [ Designated as safety issue: No ]
Incidence and frequency of adverse events [ Time Frame: 70 days ] [ Designated as safety issue: Yes ]
Frequency of hyponatraemia [ Time Frame: 70 days ] [ Designated as safety issue: Yes ]
Change from baseline in safety laboratory parameters [ Time Frame: 70 days ] [ Designated as safety issue: Yes ]

Enrollment:	152
Study Start Date:	December 2009
Study Completion Date:	August 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VA106483 1mg	Drug: VA106483 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
Experimental: VA106483 2mg	Drug: VA106483 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
Experimental: VA106483 4mg	Drug: VA106483 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
Placebo Comparator: Sugar pill	Drug: VA106483 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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038843

Locations

United States, Alabama
Alabama Research Center, LLC
Birmingham, Alabama, United States, 35209
United States, Arizona
Genova Clinical Research
Tucson, Arizona, United States, 85741
United States, California
Tower Urology Medical Group
Los Angeles, California, United States, 90048
United States, Connecticut
Grove Hill Clinical Research
New Britian, Connecticut, United States, 06052
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Discovery Clinical Trials
Celebration, Florida, United States, 34747
Avail Clinical Research LLC
DeLand, Florida, United States, 32720
Urology Center of Florida
Hialeah, Florida, United States, 33012
South Broward Research, LLC
Pembroke Pines, Florida, United States, 33027
United States, Massachusetts
Bay State Clinical Trials, Inc.
Watertown, Massachusetts, United States, 02472
United States, New York
Medical & Clinical Research Associates
Bayshore, New York, United States, 11706
Accumed Research Associates
Garden City, New York, United States, 11530
Hudson Valley Urology, PC
Poughkeepsie, New York, United States, 12601
United States, Ohio
Rapid Medical Research, Inc.
Clevland, Ohio, United States, 44122
United States, Oklahoma
Parkhurst Research Organization
Bethany, Oklahoma, United States, 73008
United States, Texas
Urology Associates of North Texas
Arlington, Texas, United States, 76017
The Urology Team P.A.
Austin, Texas, United States, 78759
Health Texas Research Institute
San Antonio, Texas, United States, 78212
Martin Diagnostic Clinic
Tomball, Texas, United States, 77375

Sponsors and Collaborators

Vantia Ltd

Investigators

Principal Investigator:	Mira Baron	Rapid Medical Research, Inc.
Principal Investigator:	David Beccia	Medical & Clinical Research Associates
Principal Investigator:	Kenneth Blaze	South Broward Research, LLC
Principal Investigator:	Mitchell Efros	Accumed Research Associates
Principal Investigator:	Marc Gittelman	South Florida Medical Research
Principal Investigator:	Evan Goldfischer	Hudson Valley Urology, PC
Principal Investigator:	Elizabeth Houser	The Urology Team P.A.
Principal Investigator:	Theodore Johnson II	Emory University
Principal Investigator:	Steven Kester	Urology Center of Florida
Principal Investigator:	Richard Lotenfoe	Discovery Clinical Trials
Principal Investigator:	Earl Martin	Martin Diagnostic Clinic
Principal Investigator:	H. David Mitcheson	Bay State Clinical Trials, Inc.
Principal Investigator:	Chris Ng	Tower Urology Medical Group
Principal Investigator:	Aris Nikas	Health Texas Research Institute
Principal Investigator:	Joseph Parkhurst	Parkhurst Research Organization
Principal Investigator:	Bruce Rankin	Avail Clinical Research LLC
Principal Investigator:	Leah Schmidt	Genova Clinical Research
Principal Investigator:	Howard Hezmall	Urology Associates of North Texas
Principal Investigator:	Wilbur Wells Jnr	Alabama Research Center, LLC
Principal Investigator:	Rafael Wurzel	Grove Hill Clinical Research

More Information

No publications provided

Responsible Party:	Dr Robert Tansley / Interim Medical Officer, Vantia Ltd, 1 Venture Road, Southampton Science Park, Southampton SO16 7NP
ClinicalTrials.gov Identifier:	NCT01038843 History of Changes
Other Study ID Numbers:	483-005
Study First Received:	December 22, 2009
Last Updated:	September 7, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vantia Ltd:

VA106483
Nocturia
males

nocturnal voids
anti-diuretic
hyponatraemia

Additional relevant MeSH terms:

Nocturia
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on February 09, 2012