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VA106483 Dose Response Study in Elderly Males

2014-08-27 03:21:25 | BioPortfolio

Summary

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.

Description

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.

Study Design

Allocation: Non-Randomized, Control: Placebo Control, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Nocturia

Intervention

VA106483, Placebo

Location

Quintiles Phase I Services
Overland Park
Kansas
United States

Status

Completed

Source

Vantia Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:21:25-0400

Clinical Trials [36 Associated Clinical Trials listed on BioPortfolio]

Efficacy Study of VA106483 in Males With Nocturia.

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

Efficacy and Safety of VA106483 in Elderly Males

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...

VA106483 and Alpha Blocker Interaction Study in Elderly Males

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.

Exploratory Study Evaluating the Effects of Darifenacin on Nocturia, Sleep and Daytime Wakefulness

The purpose of this study is to evaluate the efficacy of darifenacin in the treatment of moderate to severe nocturia in patients with overactive bladder and who do not have non-urologic ca...

Behavior and Exercise Versus Drug Treatment in Men With Nocturia (BEDTiMe)

Nocturia, waking at night from sleep to void, is a prevalent and troublesome symptom. Treatment with an alpha-adrenergic antagonist medication (α-blockers) is a standard therapy for LUTS ...

PubMed Articles [892 Associated PubMed Articles listed on BioPortfolio]

How can we develop a more clinically useful and robust algorithm for diagnosing and treating nocturia? ICI-RS 2017.

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...

Nocturia in men with benign prostatic hyperplasia.

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...

Treatment of Non-neurogenic Overactive Bladder with OnabotulinumtoxinA: Systematic Review and Meta-analysis of Prospective, Randomized, Placebo-controlled Clinical Trials.

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...

Evaluating the efficacy and safety of silodosin on nocturia in patients with benign prostatic hyperplasia: A multi-center, prospective, open-label, single-arm, phase IV trial.

To evaluate the efficacy and safety of silodosin on nocturia in patients with benign prostatic hyperplasia (BPH).

Using Placebo Beverages in Group Alcohol Studies.

Placebo beverage conditions remain a key element in the methodological toolkit for alcohol researchers interested in evaluating pharmacological and nonpharmacological factors influencing the effects o...

Medical and Biotech [MESH] Definitions

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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