Daytime Impact Sleep Study (DAISS)

This study has been terminated.
(Terminated due to lack of eligible patients)
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01779466
First received: January 23, 2013
Last updated: June 30, 2014
Last verified: June 2014
  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:


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 ]

Enrollment: 5
Study Start Date: April 2013
Study Completion Date: May 2014
Primary Completion Date: May 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:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United Kingdom
Surrey Clinical Research Centre
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: June 30, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 14, 2014