Trial of Desmopressin Orally Disintegrating Tablets (ODT) for Nocturia Due to Nocturnal Polyuria in Japanese Male Subjects

Inclusion Criteria: * Written informed consent prior to performance of any trial-related activity * Man ≥20 years of age * Nocturia symptoms present for ≥6 months prior to trial entry at Visit 1 * ≥2 nocturnal voids at the end of screening period prior to Visit 2 * Nocturnal polyuria at the end of screening period prior to Visit 2 * Bothered by nocturia on the Hsu 5-point Likert bother scale at Visit 1 and Visit 2 * Has given agreement about contraception during the trial Exclusion Criteria: * Evidence of any significant voiding dysfunction resulting in abnormally low bladder capacity at the end of the screening period prior to Visit 2 * History or evidence of significant obstructive sleep apnoea * History or diagnosis of any of the following urological diseases at Visit 1: * Interstitial cystitis or bladder pain disorder * Suspicion of moderate or severe benign prostate hyperplasia (BPH), defined as international prostate symptom score (IPSS) ≥8 points and: * Urinary flow \<5 mL/s or * Post-void residual volume \>150 mL * Stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on prior history * Chronic pelvic pain syndrome * Surgical treatment, including transurethral resection, for bladder outlet obstruction (BOO) or BPH within the past 6 months prior to Visit 1 * Symptoms of severe over-active bladder (OAB): * Defined as an over-active bladder symptom score (OABSS) ≥12 at Visit 1 * Defined as a mean of \>8 voids and a mean of ≥1 urgency episode per 24 hours at the end of the screening period prior to Visit 2 * Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence at Visit 1 * Complication of cancer or a history of cancer which has not been in remission for the last 5 years at Visit 1 * Current or a history of urologic malignancies, any lower urinary tract surgery, previous pelvic irradiation, or neoplasia at Visit 1 * History of any neurological disease affecting bladder function or muscle strength at Visit 1 * Habitual or psychogenic polydipsia based on medical history at Visit 1 or 24 hour urine output of \>2.8 L based on the voiding diary at Visit 2 * Central or nephrogenic diabetes insipidus at Visit 1 * Syndrome of inappropriate antidiuretic hormone secretion at Visit 1 * Suspicion or evidence of cardiac failure at Visit 1 * Uncontrolled hypertension at Visit 1 * Uncontrolled diabetes mellitus at Visit 1 * Hyponatraemia (serum sodium level \<135 mmol/L) at Visit 1 * Renal insufficiency at Visit 1 * Hepatic and/or biliary diseases at Visit 1 * Known or suspected hypersensitivity to desmopressin ODTs or previous desmopressin treatment for nocturia at Visit 1 * Known alcohol or substance abuse at Visit 1 * Work or lifestyle that may interfere with regular night-time sleep at Visit 1, e.g., shift workers * Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial at Visit 1 * Use of any prohibited therapy during the trial period