Daytime Impact Sleep Study - Full Text View

Purpose

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.

Condition	Intervention	Phase
Nocturia	Drug: Desmopressin Drug: Placebo (not active)	Phase 2

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

Resource links provided by NLM:

Drug Information available for: Desmopressin Desmopressin acetate

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

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

Estimated Enrollment:	48
Study Start Date:	April 2013
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Experimental A	Drug: Desmopressin
Experimental: Experimental B	Drug: Desmopressin
Placebo Comparator: Placebo	Drug: Placebo (not active)

Eligibility

Ages Eligible for Study:	35 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 3 night time voids per night
Habitual sleep of 6.5-9.5 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), 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779466

Contacts

Contact: Clinical Development Support

DK0-Disclosure@ferring.com

Locations

United Kingdom
Surrey Clinical Research Centre	Recruiting
Surrey, United Kingdom

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01779466 History of Changes
Other Study ID Numbers:	000088, 2012-004388-34
Study First Received:	January 23, 2013
Last Updated:	April 3, 2013
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Nocturia
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013

Daytime Impact Sleep Study (DAISS)