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The main purpose of the study is to evaluate the way VA106483 enters and leaves the blood and tissues over time and how the drug acts on and in the body at various dose levels compared to placebo in the same volunteer.
VA106483 is intended to be used as a treatment for patients suffering from nocturia (defined as waking to urinate at least once per night between periods of sleep). Nocturia is a condition that often worsens as sufferers get older. This may be due to an over-active bladder muscle, the bladder being able to hold less urine at night-time or over production of urine in the bladder at night.
The only antidiuretic approved for the treatment (in some countries) of nocturia is the peptide drug, desmopressin. However, as it can cause hyponatraemia in a proportion of patients above the age of 65 years it is contra-indicated in the elderly. This side-effect has not been observed with VA106483, making it potentially suitable for treating the elderly. The purpose of this study is to confirm that duration of action of VA106483 can be effectively controlled by dose and therefore that satisfactory clinical outcome in the treatment of nocturia can be achieved by individual dose titration.
Subjects will be water-loaded, dosed with either VA106483 or placebo and then urine production will be monitored to assess any anti-diuretic effect.
Allocation: Non-Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Quintiles Phase I Services
Published on BioPortfolio: 2014-08-27T03:21:25-0400
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and o...
The main purpose of this study is to investigate whether the hypotensive effects of an alpha-blocker are increased when VA106483 is given at the same time.
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SER120 is the first FDA-approved pharmacotherapy for nocturia. SER120 efficacy/safety was evaluated in 2 randomized, double-blind, placebo-controlled studies (DB3 and DB4).
Nocturia, or waking up at night to void, is a highly prevalent and bothersome symptom. Currently, there is a lack of clear and consistent recommendations regarding evaluation and management of nocturi...
We performed a systematic review and meta-analysis of randomized placebo-controlled trials that studied non-neurogenic overactive bladder patients who were treated with 100 units of onabotulinumtoxinA...
Nocturia, defined as nocturnal micturition with a frequency of at least once per night, is one of the most frequent lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH) and ofte...
To investigate the association between bladder capacity and the urine production rate in aged men with or without nocturia using a frequency volume chart (FVC).
Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.
Frequent URINATION at night that interrupts sleep. It is often associated with outflow obstruction, DIABETES MELLITUS, or bladder inflammation (CYSTITIS).
An effect usually, but not necessarily, beneficial that is attributable to an expectation that the regimen will have an effect, i.e., the effect is due to the power of suggestion.
Symptoms of disorders of the lower urinary tract including frequency, NOCTURIA; urgency, incomplete voiding, and URINARY INCONTINENCE. They are often associated with OVERACTIVE BLADDER; URINARY INCOMPETENCE; and INTERSTITIAL CYSTITIS. Lower urinary tract symptoms in males were traditionally called PROSTATISM.
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