Efficacy Study of VA106483 in Males With Nocturia.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vantia Ltd
ClinicalTrials.gov Identifier:
NCT01038843
First received: December 22, 2009
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Nocturia
Drug: VA106483
Phase 2

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Vantia Ltd
ClinicalTrials.gov Identifier: NCT01038843     History of Changes
Other Study ID Numbers: 483-005
Study First Received: December 22, 2009
Last Updated: June 18, 2014
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 July 26, 2014