A Double-blind, Randomised, Parallel-group Trial Investigating Sleep Behaviour and Daytime Performance in Nocturia Patients Treated With Desmopressin Orally Disintegrating Tablets as Compared to Placebo
Overview
- Phase
- Phase 2
- Intervention
- Desmopressin
- Conditions
- Nocturia
- Sponsor
- Ferring Pharmaceuticals
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Wake after sleep onset
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief Summary
This trial will investigate the relationship of sleep, daytime performance and nocturia in patients treated with Desmopressin or placebo. Male and Female patients will be administered Desmopressin or Placebo every day for 3 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 2 night time voids per night
- •Habitual sleep of 6-9.5 hours per night
- •Experiencing symptoms of Nocturia greater than 6 months
Exclusion Criteria
- •Greater than 10 night time voids
- •History of sleep apnoea and PLMS (Periodic Limb Movements of Sleep)
- •Other sleep disorders
- •Signs or symptoms of: Bladder outlet obstruction, severe lower urinary tract symptoms (LUTS), interstitial cystitis, moderate to severe overactive bladder (OAB), moderate to severe as judged by the investigator stress urinary incontinence
- •Urological malignancies
- •Neurogenic detrusor over activity (e.g. Parkinson, spinal cord damage, etc.)
- •Central or nephrogenic diabetes insipidus
- •Habitual or psychogenic polydipsia (fluid intake resulting in a urine production exceeding 40ml/Kg/24hrs)
- •Syndrome of inappropriate antidiuretic hormone (SIADH)
- •Cardiac failure evidence based on physical examination, cardiac medical history and electrocardiogram (ECG) output
Arms & Interventions
Experimental A
Intervention: Desmopressin
Experimental B
Intervention: Desmopressin
Placebo
Intervention: Placebo (not active)
Outcomes
Primary Outcomes
Wake after sleep onset
Time Frame: 1 month and 3 months
i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography
Mean number of nocturnal voids
Time Frame: 1 month and 3 months
As measured by voiding diary
Sleep efficiency
Time Frame: 1 month and 3 months
Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography
Sleep stage N1, N2, N3, (sleep stages in NREM (non-rapid eye movement) and REM (rapid eye movement) as a percentage of total sleep time
Time Frame: 1 month and 3 months
Measured by Polysomnography
Number of awakenings due to nocturia
Time Frame: 1 month and 3 months
Measured by Actigraphy
Latency to slow-wave sleep
Time Frame: 1 month and 3 months
Measured by Polysomnography
Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale
Time Frame: 1 month and 3 months
Daytime performance
Mean time to first void
Time Frame: 1 month and 3 months
As measured by voiding diary
Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset
Time Frame: 1 month and 3 months
Measured by Actigraphy
Percent of sleep
Time Frame: 1 month and 3 months
Measured by Actigraphy
Quality of life score measured by EQ-5D-5L
Time Frame: 1 month and 3 months
Daytime performance
Safety - incidence of adverse events
Time Frame: 1 month and 3 months
Safety - clinically significant changes in lab values
Time Frame: 1 week and 3 months
Safety - clinically significant changes in vital signs
Time Frame: 1 week, 1 month and 3 months
Safety - clinically significant changes in physical examination
Time Frame: 3 months