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Efficacy Study of VA106483 in Males With Nocturia.

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ClinicalTrials.gov Identifier: NCT01038843
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : June 20, 2014
Sponsor:
Information provided by (Responsible Party):

December 22, 2009
December 24, 2009
June 20, 2014
December 2009
July 2010   (Final data collection date for primary outcome measure)
Change in the mean number of nocturnal voids per night [ Time Frame: 70 days ]
Same as current
Complete list of historical versions of study NCT01038843 on ClinicalTrials.gov Archive Site
  • Mean duration of first sleep period [ Time Frame: 70 days ]
  • Change in nocturia-related quality of life [ Time Frame: 70 days ]
  • Incidence and frequency of adverse events [ Time Frame: 70 days ]
  • Frequency of hyponatraemia [ Time Frame: 70 days ]
  • Change from baseline in safety laboratory parameters [ Time Frame: 70 days ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Nocturia
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
    Intervention: Drug: VA106483
  • Experimental: VA106483 2mg
    Intervention: Drug: VA106483
  • Experimental: VA106483 4mg
    Intervention: Drug: VA106483
  • Placebo Comparator: Sugar pill
    Intervention: Drug: VA106483
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
August 2010
July 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01038843
483-005
No
Not Provided
Not Provided
Vantia Ltd
Vantia Ltd
Not Provided
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
Vantia Ltd
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP