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 <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