Nocturia due to Nocturnal Polyuria MedDRA version: 20.0 Level: LLT Classification code 10064016 Term: Nocturnal polyuria System Organ Class: 100000017861
Conditions
Interventions
Trade Name: NOCDURNA
Product Name: Nocdurna 50 microgram oral lyophilisate
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: DESMOPRESSIN ACET
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent prior to performance of any trial-related activity 2. Adults =18 years of age (at the time of written consent) 3. Female subjects of child-bearing potential must be willing and able to use adequate contraception throughout the trial. Documentation of an acceptable effective method of contraception must be available. All pre- and perimenopausal subjects have to perform pregnancy tests. Amenorrhea of more than 12 months duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require any pregnancy test 4. Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1 5. =2 nocturnal voids per night (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2 6. 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 7. Nocturnal polyuria, defined as NPi >33%, a ratio of Nocturnal Urine Volume (NUV) in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2 8. Bothered by nocturia as defined by an NI Diary Total Score of =10 points (raw score) as documented in the 3-day e-Diary prior to Visit 2 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 69 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 69
Exclusion criteria
Exclusion criteria: 1. Current diagnosis of Obstructive Sleep Apnoea (OSA). In case of no current diagnosis of OSA, high-risk subjects should be excluded as assessed by the STOP-Bang questionnaire at Visit 1 2. Restless Legs Syndrome (RLS) 3. Current mild to severe depression as assessed by a score of =14 on the Beck Depression Inventory-II (BDI-II) scale at Visit 1 or Visit 2 4. History or suspicion of moderate to severe Lower Urinary Tract Symptoms (LUTS) with or without Bladder Outlet Obstruction (BOO). In case of suspicion of moderate or severe LUTS with or without BOO, 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 have International Prostate Symptom Score (IPSS) =13 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) 6. Predominant daytime voiding dysfunction due to Overactive Bladder (OAB), 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) 7. Any pelvic or lower urinary tract surgery and/or radiotherapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for BOO or Benign Prostatic Hyperplasia (BPH), hysterectomy or female incontinence procedures 8. 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, or stone in the bladder or urethra causing symptoms 9. 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 10. History of any neurological disease affecting bladder function or muscle strength (e.g., Multiple Sclerosis, Parkinson’s, spinal cord injury, spina bifida) 11. Habitual (fluid intake >3L per day) or psychogenic polydipsia 12. Uncontrolled hypertension, as judged by the investigator 13. Uncontrolled diabetes mellitus, as judged by the investigator 14. Central or nephrogenic diabetes insipidus 15. Known history of Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion 16. History of gastric retention 17. Known or suspected cardiac insufficiency or other conditions associated with fluid overload, sufficient to require treatment with diuretics, including a history of such conditions 18. Hyponatraemia (serum sodium level <135 mmol/L) at Visit 1 (re-tested and confirmed, with results available within 7 days) 19. Renal insufficiency (estimated glomerular filtration rate =60 mL/min) 20. H
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the association between changes in the number of nocturnal voids and change in Nocturia Sleep Quality Scale (NSQS) total score in adult subjects with nocturia due to Nocturnal Polyuria (NP); Secondary Objective: - To assess the association between changes in Patient Global Impression of Severity (PGI-S) and change in Nocturia Sleep Quality Scale (NSQS) total score - To assess the association between Patient Global Impression of Improvement (PGI-I) and change in NSQS total score - To assess the association between change in First Undisturbed Sleep Period (FUSP) and change in NSQS total score - To assess changes from baseline in NSQS total score - To assess changes from baseline in PGI-S and Bother scales - To assess PGI-I scores - To assess changes from baseline in number of nocturnal voids - To assess changes from baseline in FUSP ;Primary end point(s): Pearson correlation coefficient between change from baseline to Week 12 in number of nocturnal voids and the Nocturia Sleep Quality Scale (NSQS) total score;Timepoint(s) of evaluation of this end point: please refer to section E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Pearson correlation coefficient between change from baseline to Weeks 1, 4 and 8 in number of nocturnal voids and the Nocturia Sleep Quality Scale (NSQS) total score - Pearson correlation coefficient between change from baseline to Weeks 1, 4, 8 and 12 in Patient Global Impression of Severity (PGI-S) and NSQS total score - Pearson correlation coefficient between PGI-I scores and change from baseline to Weeks 1, 4, 8 and 12 in NSQS total score - Pearson correlation coefficient between change from baseline to Weeks 1, 4, 8 and 12 in First Undisturbed Sleep Period (FUSP) and NSQS total score - Change from baseline in NSQS total score at Weeks 1, 4, 8 and 12 and during 12 weeks of treatment - Change from baseline in 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 - PGI-I scores at Weeks 1, 4, 8 and 12 - Change from baseline in number of nocturnal voids during 12 weeks of treatment - Change from baseline in FUSP during 12 weeks of treatment ;Timepoint(s) of evaluation of this end point: please refer to section E.5.2 | — |
Countries
Canada, Czech Republic, Hungary, Netherlands, United Kingdom, United States
Contacts
Public ContactClinical Development Support
Ferring Pharmaceuticals A/S
Outcome results
None listed