Nocturia
Conditions
Keywords
VA106483, Nocturia, males, nocturnal voids, anti-diuretic, hyponatraemia
Brief summary
To investigate the effect of VA106483 on nocturia related clinical outcomes compared to placebo.
Detailed 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.
Interventions
DRUGVA106483
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
Sponsors
Vantia Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean number of nocturnal voids per night | 70 days |
Secondary
| Measure | Time frame |
|---|---|
| Mean duration of first sleep period | 70 days |
| Change in nocturia-related quality of life | 70 days |
| Incidence and frequency of adverse events | 70 days |
| Frequency of hyponatraemia | 70 days |
| Change from baseline in safety laboratory parameters | 70 days |
Countries
United States
Outcome results
None listed