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

Inclusion Criteria

• Adults ≥18 years of age (at the time of written consent)
• Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1
• ≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2
• The largest single voided volume must be ≥200 mL (at least 1 void ≥200 mL) as documented in the 3-day e-Diary prior to Visit 2
• Nocturnal polyuria, defined as Nocturnal Polyuria index >33%, a ratio of Nocturnal Urine Volume in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2
• ≥20% decrease in the nocturnal diuresis rate (mL/min) (that was recorded at Visit 2) as documented in the 3-day e-Diary prior to Visit 3

Exclusion Criteria

• Current diagnosis of Obstructive Sleep Apnoea (OSA)
• Restless Legs Syndrome (RLS)
• Bladder Outlet Obstruction (BOO) or urine flow 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