A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults

Exclusion Criteria

• •Current diagnosis of Obstructive Sleep Apnoea (OSA)
• •Restless Legs Syndrome (RLS)
• •Bladder Outlet Obstruction (BOO) or urine flow \<5 mL/s, as confirmed by uroflowmetry upon suspicion during screening prior to Visit 2
• •Urinary incontinence defined as an average of \>1 episode/day in the 3-day e-Diary prior to Visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary)
• •Any pelvic or lower urinary tract surgery and/or radio therapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for Bladder Outlet Obstruction or Benign Prostatic Hyperplasia, hysterectomy or female incontinence procedures
• •Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder-related pain, chronic pelvic pain syndrome, or stone in the bladder or urethra causing symptoms
• •A history of cancer with the last date of disease activity/presence of malignancy within the last 12 months prior to Visit 1, except for adequately treated basal cell carcinoma of the skin
• •History of any neurological disease affecting bladder function or muscle strength (e.g., Multiple Sclerosis, Parkinson's, spinal cord injury, spina bifida)
• •Habitual (fluid intake \>3L per day) or psychogenic polydipsia
• •Uncontrolled hypertension, as judged by the investigator
• •Uncontrolled diabetes mellitus, as judged by the investigator
• •Central or nephrogenic diabetes insipidus
• •Known history of Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion
• •History of gastric retention
• •Suspicion or evidence of congestive heart failure, (New York Heart Association (NYHA) class II, III, IV)
• •Hyponatraemia:
• •* Serum sodium level \<135 mmol/L at Visit 1(re-tested, with results available within 7 days)
• •* Serum sodium level \<130 mmol/L at Visit 3 (re-tested, with results available within 7 days)
• •Use of any prohibited therapy listed below:
• •* Current or former (within 3 months prior to screening) treatment with any other investigational medicinal product (IMP)
• •* Unstable electrostimulation or behavioural bladder training program less than 3 months prior to screening (stable electrostimulation or behavioural bladder training program started at least 3 months before screening are acceptable)
• •* Thiazide diuretics
• •* Antiarrhythmic agents
• •* V2-receptor antagonists/agonists (e.g., vaptans/desmopressin, vasopressin)
• •* Loperamide
• •* Botulinum toxin (cosmetic non-urological use is acceptable)
• •* Valproate