Daytime Impact Sleep Study
Information source: Ferring Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nocturia
Intervention: Desmopressin (Drug); Placebo (not active) (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s): Clinical Development Support, Study Director, Affiliation: Ferring Pharmaceuticals
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean number of nocturnal voidsWake after sleep onset Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale Mean time to first void Sleep efficiency 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 Number of awakenings due to nocturia Latency to slow-wave sleep Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset Percent of sleep Number of awakenings due to nocturia Quality of life score measured by EQ-5D-5L Safety - incidence of adverse events Safety - clinically significant changes in lab values Safety - clinically significant changes in vital signs Safety - clinically significant changes in physical examination
Eligibility
Minimum age: 25 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
- Uncontrolled hypertension
- Uncontrolled diabetes mellitus
- Hyponatraemia with sodium <135 mmol/L
- Renal insufficiency
- Known or suspected clinically significant hepatic and/or biliary diseases
Locations and Contacts
Surrey Clinical Research Centre, Surrey, United Kingdom
Additional Information
Starting date: April 2013
Last updated: April 24, 2015
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