A trial to investigate efficacy, safety and tolerability of FE 201836 for Nocturia due to Nocturnal Polyuria in adults

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 300

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

* Current diagnosis of Obstructive Sleep Apnoea (OSA).
* Restless Legs Syndrome (RLS)
* Bladder Outlet Obstruction (BOO) or urine <5mL/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/prescence 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 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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