Clinical Trial: Efficacy Study of VA106483 in Males With Nocturia.
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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
Brief Summary: To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
Detailed Summary:
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.
Sponsor: Vantia Ltd
Current Primary Outcome: Change in the mean number of nocturnal voids per night [ Time Frame: 70 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Vantia Ltd
Dates:
Date Received: December 22, 2009
Date Started: December 2009
Date Completion:
Last Updated: June 18, 2014
Last Verified: June 2014
