Efficacy Study of VA106483 in Males With Nocturia.

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

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

Study Overview

• Status: Completed
• Conditions: Nocturia
• Intervention / Treatment: Drug: VA106483

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.

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the mean number of nocturnal voids per night	70 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean duration of first sleep period	70 days
Change in nocturia-related quality of life	70 days
Incidence and frequency of adverse events	70 days
Frequency of hyponatraemia	70 days
Change from baseline in safety laboratory parameters	70 days

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: December 22, 2009
• First Submitted That Met QC Criteria: December 22, 2009
• First Posted (Estimate): December 24, 2009

Study Record Updates

• Last Update Posted (Estimate): June 20, 2014
• Last Update Submitted That Met QC Criteria: June 18, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Nocturia; VA106483; males; hyponatraemia; nocturnal voids; anti-diuretic
• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Nocturia
• Other Study ID Numbers: 483-005