Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo

A Multi-centre, Double-blind, Randomised, Placebo-controlled, Parallel-group, Comparative Trial to Investigate the Dose-Response of 4 Different Dose Levels of Minirin Melt and Placebo in Water-loaded Male and Female Japanese Nocturia Patients (Single Dose), and to Study the Efficacy of 4 Different Dose Levels of Minirin Melt and Placebo After 28 Days of Dosing (Multiple Doses)

This is a multi-centre, randomised, placebo-controlled, double-blind, parallel-group comparative trial to be conducted in nocturia patients. The trial is designed to characterize the dose-response relationship of Minirin (desmopressin) Melt in order to establish correct dose recommendations in the target patient population. In particular, the trial is designed to link the duration of action to the clinical endpoint. Furthermore, the trial is designed to describe the safety of four different dose levels of desmopressin.

Inclusion Criteria:

• Given written informed consent prior to any trial-related activity is performed
• Aged 55-75 years
• Mean number of nocturnal voids of at least two per night
• Reached post-menopause (applicable to females only)

Exclusion Criteria:

• Evidence of bladder outlet obstruction (BOO); or a urine flow of less than 5 mL/s (applicable to males only)
• A surgical treatment for BOO or prostatic hyperplasia within the past 6 months (applicable to males only)
• Showing symptoms of any of the following diseases and having a mean number of nocturnal voids exceeding four per night: Benign prostatic hyperplasia, overactive bladder, interstitial cystitis, severe stress urinary incontinence
• Psychosomatic or habitual polydipsia
• Urinary retention; or a post void residual volume in excess of 150 mL
• A history or complication of urologic malignancy (e.g. bladder cancer or prostate cancer)
• Complication of genito-urinary pathology (e.g. infection, stone, or neoplasia)
• Complication of neurogenic detrusor activity
• Complication or suspicion of heart failure
• Uncontrolled hypertension
• Uncontrolled diabetes mellitus
• Complication of hepatobiliary disease
• Abnormal serum creatinine level
• Complication of hyponatraemia, or serum sodium level <135 mEq/L
• Central or nephrogenic diabetes insipidus (CDI or NDI)
• Syndrome of inappropriate antidiuretic hormone (SIADH)
• Obstructive sleep apnea
• Alcohol dependency or drug abuse
• A job or lifestyle that may interfere with regular night-time sleep
• Previous desmopressin treatment
• Treatment with another investigational product within the past 3 months
• A need for treatment with a prohibited concomitant drug for a complication or other problem
• A mental condition, the lack of decision-making ability, dementia or a speech handicap
• Any other reason that the Investigator believes inappropriate