Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel-group Trial With an Open-label Extension to Demonstrate the Efficacy and Safety of Desmopressin Orally Disintegrating Tablets for the Treatment of Nocturia in Adult Males

The purpose of this trial was to confirm/establish long-term safety and efficacy of desmopressin orally disintegrating tablets at dose levels of 50 μg and 75 μg and to further evaluate the safety of an efficacious higher dose level of 100 μg in males with nocturia.

Inclusion Criteria:

• Written informed consent prior to performance of any trial-related activity
• Male sex 18 years of age or older
• At least 2 voids every night in a consecutive 3-day period during the screening period based on the patient diary.

Exclusion Criteria:

• Evidence of severe daytime voiding dysfunction defined as: Urge urinary incontinence (more than 1 episode/day in the 3-day diary period), Urgency (more than 1 episode/day in the 3-day diary period), Frequency (more than 8 daytime voids/day in the 3-day diary period)
• Interstitial Cystitis
• Chronic prostatitis/chronic pelvic pain syndrome
• Suspicion of bladder outlet obstruction (BOO) or a urine flow of less than 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO
• Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia within the past 6 months
• Urinary retention or a post void residual volume in excess of 250 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
• Habitual or psychogenic fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours
• Central or nephrogenic diabetes insipidus.
• Syndrome of inappropriate anti-diuretic hormone.
• Current or a history of urologic malignancies e.g. urothelium, prostate, or kidney cancer
• Genitourinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms
• Neurogenic detrusor activity (detrusor overactivity)
• Suspicion or evidence of cardiac failure
• Uncontrolled hypertension
• Uncontrolled diabetes mellitus
• Hyponatraemia: Serum sodium level must be within normal limits
• Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
• Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL
• History of obstructive sleep apnea
• Previous desmopressin treatment for nocturia
• Treatment with another investigational product within 3 months prior to screening
• Concomitant treatment with any prohibited medication, i.e. loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
• Known alcohol or substance abuse
• Work or lifestyle that may interfere with regular nighttime sleep 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