Trial | NCT01038843  Report issue

Title

Efficacy Study of VA106483 in Males With Nocturia.
A Randomised, Double-blind, Placebo-controlled, Parallel Group, Dose-titration Study to Determine the Efficacy and Safety of VA106483 in Male Subjects With Nocturia

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    152
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
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 Started
Dec 31
2009
Primary Completion
Jul 31
2010
Study Completion
Aug 31
2010
Last Update
Jun 20
2014
Estimate

Drug VA106483

Drug: VA106483 Once daily oral dose of 1 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 2 mg VA106483 or matching placebo for 14 (+3) days. Once daily oral dose of 4 mg VA106483 or matching placebo for 28 days. Placebo: as above

VA106483 1mg Experimental

VA106483 2mg Experimental

VA106483 4mg Experimental

Sugar pill Placebo Comparator

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
No Results Posted