Nocturia due to Nocturnal Polyuria MedDRA version: 20.0 Level: LLT Classification code 10064016 Term: Nocturnal polyuria System Organ Class: 100000004857
Conditions
Interventions
Product Name: FE 201836
Pharmaceutical Form: Oral solution
INN or Proposed INN: not applicable
CAS Number: 1647120-04-4
Current Sponsor code: FE 201836
Other descriptive name: FE 201836
Concentration
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion 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 >250 mL (at least 1 void >250 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 * Bothered by nocturia as defined by an Nocturia Impact Diary Total Score of =10 points (raw score) 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
Exclusion criteria: * Current diagnosis of Obstructive Sleep Apnoea (OSA). In case of no current diagnosis of Obstructive Sleep Apnoea, high-risk subjects should be excluded as assessed by the STOP-Bang questionnaire at Visit 1 * Restless Legs Syndrome (RLS) * History or suspicion of moderate to severe Lower Urinary Tract Symptoms with or without Bladder Outlet Obstruction. In case of suspicion of moderate or severe Lower Urinary Tract Symptoms with or without Bladder Outlet Obstruction, subjects should be excluded from the trial as follows: ? - All subjects with a Post-void Residual (PVR) >150 mL, as confirmed by ultrasound during screening prior to Visit 2 ? - Male subjects who also have International Prostate Symptom Score (IPSS) =8 points and urinary 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) * Predominant daytime voiding dysfunction due to Overactive Bladder, at Visit 2, defined as: ? - Frequency (an average of >8 daytime voids per day during the 3-day diary period) and ? - =1 daily urgency episode (the subject could not postpone voiding or the subject leaked before arriving to the toilet) * 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 * Serum triglyceride level >400 mg/dL * 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, vasop
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the dose-response of FE 201836 with respect to the number of nocturnal voids in subjects with nocturia due to nocturnal polyuria.;Primary end point(s): Change from baseline in number of nocturnal voids during 12 weeks of treatment.;Timepoint(s) of evaluation of this end point: please refer to Section E.5.1;Secondary Objective: * To evaluate responder rates with regards to changes in number of nocturnal voids. *To psychometrically validate the Nocturia Impact Diary© (NI Diary). * To evaluate the clinically meaningful patient benefit of FE 201836 based on the Nocturia Impact Diary data. * To evaluate FE 201836 with respect to sleep benefit, i.e., duration of the First Undisturbed Sleep Period (FUSP) and sleep related Patient Reported Outcomes (PROs). * To evaluate the pharmacodynamic effect of FE 201836 with respect to nocturnal diuresis rate and nocturnal polyuria. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): * Change from baseline in number of nocturnal voids at Weeks 1, 4, 8 and 12. * Responder rate defined as 50% reduction in nocturnal voids from baseline at Weeks 1, 4, 8 and 12 and during 12 weeks of treatment. * Change from baseline in NI Diary Total Score at Weeks 1, 4, 8 and 12 and during 12 weeks of treatment. * Change from baseline in NI Diary Overall Impact Score at Weeks 1, 4, 8 and 12 and during 12 weeks of treatment. * Patient Global Impression of Improvement (PGI-I) urinary symptoms scores at Weeks 1, 4, 8 and 12. * Change from baseline in Patient Global Impression of Severity (PGI-S) scores at Weeks 1, 4, 8 and 12. * Change from baseline in Bother as measured by the Hsu 5-point Likert Bother scale at Weeks 1, 4, 8 and 12. * Change from baseline in Insomnia Severity Index (ISI) at Weeks 4, 8 and 12. * Change from baseline in FUSP at 1, 4, 8 and 12 weeks of treatment and during 12 weeks. * Change from baseline in nocturnal diuresis rate (hourly) profiles at Week 1 and Week 12. * Change from baseline in NUV at Week 1 and Week 12.;Timepoint(s) of evaluation of this end point: please refer to Section E.5.2 | — |
Countries
Belgium, Canada, Czech Republic, France, Germany, Hungary, Poland, United States
Contacts
Public ContactClinical Development Support
Ferring Pharmaceuticals A/S
Outcome results
None listed