Nocturia
Conditions
Keywords
VA106483, fedovapagon, Nocturia, males, nocturnal voids, anti-diuretic
Brief summary
The purpose of this study is to determine the dose level(s) of fedovapagon which result in a decrease in the mean nocturnal void frequency.
Detailed description
Fedovapagon is a selective vasopressin V2 receptor (V2 receptor) agonist that is being developed for the treatment of Nocturia. The antidiuretic effect of V2 receptor stimulation in the kidneys is well established through the use of the peptide agonist, desmopressin, which shows clinical benefit in diabetes insipidus, primary nocturnal enuresis and Nocturia. Nocturia, defined as the complaint that the individual has to wake at night one or more times to void, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of Nocturnal Voids). It is the most bothersome symptom of benign prostatic hypertrophy (BPH) and has been linked to an age-dependent loss in circadian release of endogenous nocturnal vasopressin and consequent over production of urine at night (Nocturnal Polyuria). The purpose of this Phase IIb study is to determine the efficacy of different doses of fedovapagon in reducing the number of times subjects with Nocturia void during the night together with other parameters including increasing the time between going to bed and waking to first void. By establishing the effective doses of fedovapagon on these clinical endpoints, the data from this study will determine the most appropriate dose(s) of fedovapagon for the treatment of Nocturia to be taken forward into further studies.
Interventions
Sponsors
Vantia Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
55 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males aged 55 or over * History and/ or symptoms of Nocturia (2 - 5 voids per night) * Generally well (concomitant illness / conditions well controlled) * Serum sodium, potassium, chloride and bicarbonate within normal limits * No clinically significant abnormalities in other laboratory parameters, urinalysis, electrocardiogram (ECG) or physical examination * Prostate specific antigen (PSA) within the normal range or not considered clinically significant * Ability to comply with the requirements of the study * Written informed consent.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the mean nocturnal urine voids | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Change in the mean nocturnal urine voids | 4 weeks |
| Change in the mean time to first nocturnal void | 4 weeks |
| Change in Nocturia-related quality of life (N-QOL) | 4 weeks |
Countries
United States
Outcome results
None listed