Clinical trial NCT01038843: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nocturia
Keywords: VA106483
Nocturia
males
nocturnal voids
anti-diuretic
hyponatraemia
Lead sponsor: Vantia Ltd
Sponsor class: INDUSTRY
First posted: 2009-12-24
Enrollment: 152
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in the mean number of nocturnal voids per night
timeFrame: 70 days
Secondary outcomes:
measure: Mean duration of first sleep period
timeFrame: 70 days
measure: Change in nocturia-related quality of life
timeFrame: 70 days
measure: Incidence and frequency of adverse events
timeFrame: 70 days
measure: Frequency of hyponatraemia
timeFrame: 70 days
measure: Change from baseline in safety laboratory parameters
timeFrame: 70 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Research Center, LLC
state: Alabama
city: Tucson
country: United States
facility: Genova Clinical Research
state: Arizona
city: Los Angeles
country: United States
facility: Tower Urology Medical Group
state: California
city: New Britian
country: United States
facility: Grove Hill Clinical Research
state: Connecticut
city: Aventura
country: United States
facility: South Florida Medical Research
state: Florida
city: Celebration
country: United States
facility: Discovery Clinical Trials
state: Florida
city: DeLand
country: United States
facility: Avail Clinical Research LLC
state: Florida
city: Hialeah
country: United States
facility: Urology Center of Florida
state: Florida
city: Pembroke Pines
country: United States
facility: South Broward Research, LLC
state: Florida
city: Watertown
country: United States
facility: Bay State Clinical Trials, Inc.
state: Massachusetts
city: Bayshore
country: United States
facility: Medical & Clinical Research Associates
state: New York
city: Garden City
country: United States
facility: Accumed Research Associates
state: New York
city: Poughkeepsie
country: United States
facility: Hudson Valley Urology, PC
state: New York
city: Clevland
country: United States
facility: Rapid Medical Research, Inc.
state: Ohio
city: Bethany
country: United States
facility: Parkhurst Research Organization
state: Oklahoma
city: Arlington
country: United States
facility: Urology Associates of North Texas
state: Texas
city: Austin
country: United States
facility: The Urology Team P.A.
state: Texas
city: San Antonio
country: United States
facility: Health Texas Research Institute
state: Texas
city: Tomball
country: United States
facility: Martin Diagnostic Clinic
state: Texas
Study officials:
affiliation: Rapid Medical Research, Inc.
name: Mira Baron
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical & Clinical Research Associates
name: David Beccia
role: PRINCIPAL_INVESTIGATOR
affiliation: South Broward Research, LLC
name: Kenneth Blaze
role: PRINCIPAL_INVESTIGATOR
affiliation: Accumed Research Associates
name: Mitchell Efros
role: PRINCIPAL_INVESTIGATOR
affiliation: South Florida Medical Research
name: Marc Gittelman
role: PRINCIPAL_INVESTIGATOR
affiliation: Hudson Valley Urology, PC
name: Evan Goldfischer
role: PRINCIPAL_INVESTIGATOR
affiliation: The Urology Team P.A.
name: Elizabeth Houser
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Theodore Johnson II
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology Center of Florida
name: Steven Kester
role: PRINCIPAL_INVESTIGATOR
affiliation: Discovery Clinical Trials
name: Richard Lotenfoe
role: PRINCIPAL_INVESTIGATOR
affiliation: Martin Diagnostic Clinic
name: Earl Martin
role: PRINCIPAL_INVESTIGATOR
affiliation: Bay State Clinical Trials, Inc.
name: H. David Mitcheson
role: PRINCIPAL_INVESTIGATOR
affiliation: Tower Urology Medical Group
name: Chris Ng
role: PRINCIPAL_INVESTIGATOR
affiliation: Health Texas Research Institute
name: Aris Nikas
role: PRINCIPAL_INVESTIGATOR
affiliation: Parkhurst Research Organization
name: Joseph Parkhurst
role: PRINCIPAL_INVESTIGATOR
affiliation: Avail Clinical Research LLC
name: Bruce Rankin
role: PRINCIPAL_INVESTIGATOR
affiliation: Genova Clinical Research
name: Leah Schmidt
role: PRINCIPAL_INVESTIGATOR
affiliation: Urology Associates of North Texas
name: Howard Hezmall
role: PRINCIPAL_INVESTIGATOR
affiliation: Alabama Research Center, LLC
name: Wilbur Wells Jnr
role: PRINCIPAL_INVESTIGATOR
affiliation: Grove Hill Clinical Research
name: Rafael Wurzel
role: PRINCIPAL_INVESTIGATOR
References: