Clinical Trial Investigating Sleep Behaviour and Daytime Performance in Nocturia Patients Treated with Desmopressin Orally Disintegrating Tablets as compared to Placebo
- Conditions
- octuriaTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2012-004388-34-GB
- Lead Sponsor
- Ferring Pharmaceuticals A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
1. Written informed consent has been given prior to performance of any trial-related activity
2. Male or female patients, aged 25-65 years at the time of written consent, who currently have a regular sleep/wake schedule with minimal daytime napping
3. Nocturia symptoms which have been present for =6 months prior to trial entry (patient-reported)
4. At least 2 nocturnal voids per night as judged by the Investigator during both 3-day diary periods
5. A nocturia index >1 (nocturnal urine production exceeding maximum voided volume)
6. A time-in-bed period of between 6.0 and 9.5 hours per night (based on screening diary and actigraphy)
7. The patient is able to read and understand the informed consent form and understand the trial procedures
8. Pre- or peri-menopausal women must have a negative pregnancy test and be willing and able to use a reliable method of contraception throughout the trial. In the context of this trial, an effective method is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly such as: implants, injectables, combined or progesterone only oral contraceptives, sexual abstinence or vasectomised (male patients or partners). 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 a pregnancy test
9. Be willing and able to stay at the sleep centre as required by the protocol.
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 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
1. Evidence of severe voiding dysfunction defined as >10 nocturnal voids as documented on any given night in the voiding diary during the screening period
2. History of, or evidence of obstructive sleep apnoea (AHI >10) and PLMS (=10 arousals) as measured by PSG at Visit 1b
3. Evidence of other sleep disorders which are independent of nocturia
4. Signs or symptoms of any of the following diseases:
• severe bladder outlet obstruction with a Q max <5 ml/sec as confirmed by uroflowmetry; urinary retention or a post-void residual volume in excess of 150 mL (in women) or 250 mL (in men) as confirmed by bladder ultrasound
• severe lower urinary tract symptoms (LUTS) as defined by International Prostate Symptom Score (IPSS) (20 to 35 represents severe symptoms)
• interstitial cystitis
• moderate to severe overactive bladder (OAB) defined as =8 daytime voids per day/night time cycle, and/or any urge urinary incontinence (UUI) episode as documented in the 3-day voiding diary period just before Visit 2 patients with UUI are to be excluded.
• moderate to severe, as judged by the Investigator, stress urinary incontinence or mixed incontinence, where stress incontinence is the predominant component based on previous history
5. Genito-urinary tract pathology which in the opinion of the Investigator may 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 and urethra causing symptoms
6. Urological malignancies
7. Neurogenic detrusor overactivity (e.g. parkinson, spinal cord damage, etc.)
8. Central or nephrogenic diabetes insipidus
9. Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding >40 mL/kg/24 hours)
10. Syndrome of inappropriate antidiuretic hormone (SIADH)
11. Cardiac failure, evidence based on physical examination, cardiac medical history, and electrocardiogram (ECG) output
12. Uncontrolled hypertension
13. Uncontrolled diabetes mellitus
14. Hyponatraemia with a serum sodium level <135 mmol/L or history of hyponatraemia
15. Renal insufficiency: Serum creatinine must be within normal laboratory reference intervals and estimated glomerular filtration rate must be =50 mL/min
16. Known or suspected clinically significant hepatic and/or biliary diseases:
•aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range (=2 X ULN) and total bilirubin level must not be more than 1.5 mg/dL
•if AST and/or ALT =2 but =3 X ULN, total bilirubin level must be normal
•if total bilirubin level 1.5-2.0 mg/dL, AST and/or ALT must be normal
17. Women who are pregnant, breastfeeding, or who plan to become pregna
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