Daytime Impact Sleep Study

Nocturia Clinical Trial

— DAISS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01779466
• Other study ID #: 000088
• Secondary ID: 2012-004388-34
• Status: Terminated
• Phase: Phase 2
• First received: January 23, 2013
• Last updated: April 24, 2015
• Start date: April 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nocturia

Intervention

Drug:
• Desmopressin

• Placebo (not active)

Locations

Country	Name	City	State
United Kingdom	Surrey Clinical Research Centre	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean number of nocturnal voids	As measured by voiding diary	1 month and 3 months	No
Primary	Wake after sleep onset	i.e. time in minutes of epochs scored as wake from sleep onset latency until lights on. Measured by Polysomnography	1 month and 3 months	No
Primary	Daytime sleepiness score as measured by Karolinska Sleepiness Scale and Epworth Sleepiness Scale	Daytime performance	1 month and 3 months	No
Primary	Mean time to first void	As measured by voiding diary	1 month and 3 months	No
Primary	Sleep efficiency	Sleep efficiency equals total sleep time divided by total recording time multiplied by 100. Measured by Polysomnography	1 month and 3 months	No
Primary	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	Measured by Polysomnography	1 month and 3 months	No
Primary	Number of awakenings due to nocturia	Measured by Polysomnography	1 month and 3 months	No
Primary	Latency to slow-wave sleep	Measured by Polysomnography	1 month and 3 months	No
Primary	Wake after sleep onset (WASO) i.e total minutes of wakefulness recorded after sleep onset	Measured by Actigraphy	1 month and 3 months	No
Primary	Percent of sleep	Measured by Actigraphy	1 month and 3 months	No
Primary	Number of awakenings due to nocturia	Measured by Actigraphy	1 month and 3 months	No
Primary	Quality of life score measured by EQ-5D-5L	Daytime performance	1 month and 3 months	No
Primary	Safety - incidence of adverse events		1 month and 3 months	Yes
Primary	Safety - clinically significant changes in lab values		1 week and 3 months	Yes
Primary	Safety - clinically significant changes in vital signs		1 week, 1 month and 3 months	Yes
Primary	Safety - clinically significant changes in physical examination		3 months	Yes