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

This is an interventional treatment trial for Nocturia Read More

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