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Efficacy Study of VA106483 in Males With Nocturia.

2014-07-24 14:10:30 | BioPortfolio

Summary

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

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Nocturia

Intervention

VA106483

Location

Alabama Research Center, LLC
Birmingham
Alabama
United States
35209

Status

Active, not recruiting

Source

Vantia Ltd

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:30-0400

Clinical Trials [33 Associated Clinical Trials listed on BioPortfolio]

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.

VA106483 Dose Response Study in Elderly Males

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 ...

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 [16 Associated PubMed Articles listed on BioPortfolio]

Desmopressin for treating nocturia in men.

Nocturia is the bothersome symptom of awakening one or more times per night to void. Desmopressin is a commonly used medication for treating nocturia.

Pharmacotherapy for Nocturia.

To assess current pharmacological principles used for treatment of nocturia/nocturnal polyuria.

Nocturia is Associated with Poor Sleep Quality Among Older Women in the Study of Osteoporotic Fractures.

(1) To examine relationships between frequency of nocturia and self-reported sleep quality and objective sleep measures in older women, and (2) to estimate the amount of variation in sleep measures th...

The Relationship Between Sleep Disorders and Lower Urinary Tract Symptoms: Results from the National Health and Nutrition Examination Survey (NHANES).

It is well established that sleep disorders (SDs) are associated with the prevalence of nocturia in men. While previous literature supports that patients with SDs are at increased risk of nocturia, th...

Efficacy and Safety of SER120 Nasal Spray in Nocturia Patients Pooled Analysis of 2 Randomized, Double-Blind, Placebo-Controlled Phase 3 Trials.

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).

Medical and Biotech [MESH] Definitions

Frequent URINATION at night that interrupts sleep. It is often associated with outflow obstruction, DIABETES MELLITUS, or bladder inflammation (CYSTITIS).

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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