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

Launched by FERRING PHARMACEUTICALS · Jun 26, 2017

Keywords

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Gender

ALL

Eligibility criteria

• 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