A trial to investigate efficacy, safety and tolerability of FE 201836 for Nocturia due to Nocturnal Polyuria in adults
- Conditions
- octuria due to Nocturnal PolyuriaMedDRA version: 20.0Level: LLTClassification code 10064016Term: Nocturnal polyuriaSystem Organ Class: 100000004857Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
- Registration Number
- EUCTR2016-003851-31-CZ
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 531
* 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
* 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/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 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.;Secondary Objective: * To evaluate responder rates with regards to changes in number of nocturnal voids.<br>*To psychometrically validate the Nocturia Impact Diary© (NI Diary).<br>* To evaluate the patient benefit of FE 201836 based on the Nocturia Impact Diary data.<br>* To evaluate the clinical benefit of FE 201836 based on reduction in nocturnal voiding.<br>* 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).<br>* To evaluate the pharmacodynamic effect of FE 201836 with respect to nocturnal diuresis rate and 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 Outcome Measures
Name Time Method