Demonstrate the safety and tolerability of desmopressin ODT during long-term treatment of subjects with nocturia due to nocturnal polyuria, for up to 1 year
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
503
Investigational site (there may be other sites in this country)
Tokyo, Japan
The frequency and severity of adverse events
During long-term treatment
Time frame: Up to 1 year
Clinically significant changes in laboratory values and vital signs
During long-term treatment
Time frame: Up to 1 year
The incidence and severity of hyponatraemia
Measured by serum sodium levels during long-term treatment
Time frame: Up to 1 year
Change from baseline in mean number of nocturnal voids
Time frame: Week 12, 24, 40 and 52
Change from baseline in mean time to first awakening to void
Time frame: Week 12, 24, 40 and 52
Change from baseline in mean nocturnal urin volume
Time frame: Week 12, 24, 40 and 52
Change from baseline in mean Nocturnal Polyuria Index (NPI)
Time frame: Week 12, 24, 40 and 52
Change from baseline in Nocturia-Specific Quality-of-Life Questionnaire (N-QoL)
Time frame: Week 12, 24, 40 and 52
Change from baseline in Insomnia Severity Index (ISI)
Time frame: Week 12, 24, 40 and 52
Change from baseline in bother score
Assessed by the Hsu 5-point Likert bother scale
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Time frame: Week 12, 24, 40 and 52