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Desmopressin Melt: Impact on Sleep and Daytime Functioning (SLEEP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by University Hospital, Ghent.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01645475
First received: July 13, 2012
Last updated: July 17, 2012
Last verified: July 2012
  Purpose

Nocturnal enuresis affects 10% of the 7-year-old children and is essentially caused by a mismatch between nocturnal bladder capacity and the amount of urine produced during the night together with failure of the child to awaken in response to a full bladder.Urine overproduction at night or nocturnal polyuria (NP) is a major factor contributing to monosymptomatic nocturnal enuresis (MNE) pathophysiology in a large proportion of patients.

Since NP is related to an abnormal circadian rhythm of arginine vasopressin (AVP) secretion, the synthetic AVP analogue desmopressin is widely used to treat MNE.

It is recommended by the International Consultation on Incontinence (grade A,level 1). Desmopressin is available in 3 different formulations: nasal spray, tablet and the newest form melt.

Baeyens et al demonstrated an increased prevalence of attention deficit-hyperactivity disorder (ADHD) in children with MNE According to recent data there is a high incidence of periodic limb movements in sleep at night in children with nocturnal enuresis. Those children have an increased cortical arousability leading to awakening.

The frequent awakening most likely has an influence on concentration and other ADHD-symptoms in daily life.

This study will assess the impact of desmopressin melt on prepulse inhibition, ADHD-symptoms, cognition and learning, sleep, quality of life and self esteem.

New patients aged 6-16 years with monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems are tested before the start of the study medication desmopressin melt (T1) and 6 months later (T2). It is a multi-method, multi-informant study.


Condition Intervention Phase
Monosymptomatic Nocturnal Enuresis.
Drug: Desmopressin lyophilisate (Melt)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Desmopressin Melt: Impact on Sleep and Daytime Functioning? A Prospective Study.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Bladder information: voiding calender [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Voiding calendar

  • Urine concentration [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Forced diuresis and 24h concentration profile with measurement of Na, K, creatinin, osmolality

  • IQ (Intelligent Quotient) [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Wechsler Intelligence Scale for Children-Third Edition (WISC-III) short version

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Child Behavior Checklist - CBCL (parents)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    "Vragenlijst voor Gedragsproblemen bij Kinderen" (VvGK): questionnaire to screen for ADHD and behavioral disorders (parents, teacher)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    TRF: Teacher Report Form (teacher)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Behavior Rating Inventory of Executive Function (BRIEF): questionnaire to assess executive functions) (parents, teacher)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Pediatric Incontinence Questionniare (PinQ): questionnaire to measure health related quality of life, specific enuresis (parents + child)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Pediatric Quality of Life Inventory (PedsQL): questionnaire to measure health related quality of life (parents + child)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Kiddie Schedule for Affective Disorders and Schizofrenia (K-SADS): diagnostic interview if CBCL/TRF is (sub)clinical (parents + child)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Cambridge Neuropsychological Test Automated Battery (CANTAB) (child)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    IQ: WISC-III subtest Digit Span - children are orally given sequences of numbers and asked to repeat them, either as heard or in reverse order. (child)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Test of Everyday Attention for Children (TEA-ch): subtest Secret code + Score DT (sustained attention task) (child)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    "Competentiebelevingsschaal voor Kinderen/Adolescenten" (CBSK/CBSA): questionnaire to measure self-esteem in children or adolescents OR The pictorial scale of perceived competence and social acceptance for young children. (child)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Swanson, Kotkin, Agler, Mylnn, and Pelham (SKAMP) Rating Scale: observation scale (teacher)

  • Psychological functioning questionnaire [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    School results: copy of schoolreport (+median) (teacher)

  • Sleep [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Pediatric Sleep Questionnaire (questionnaire to assess the quality of sleep) (parents)

  • Sleep [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Children's Sleep Habits Questionnaire (CSHQ) (parents)

  • Sleep [ Time Frame: Change between day 1 before start of studymedication and 6 months later ] [ Designated as safety issue: No ]
    Polysomnography (overnight hospitalization) (child)


Enrollment: 30
Study Start Date: April 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desmopressin lyophilisate (Melt)
Patients receiving Desmopressin lyophilisate (Melt).
Drug: Desmopressin lyophilisate (Melt)
Patient receives Desmopressin lyophilisate (Melt).

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • New patient
  • age 6 to 16 years
  • monosymptomatic nocturnal enuresis, nocturnal polyuria and sleep problems

Exclusion Criteria:

  • mental retardation
  • autism spectrum disorders
  • daytime incontinence resistant to therapy
  • dysfunctional voiding
  • poor therapy-compliance
  • diuretics, antihypertensives, uropathy, renal abnormalities
  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: NCT01645475

Locations
Belgium
Ghent University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Ferring Pharmaceuticals
Investigators
Principal Investigator: Johan Vande Walle, MD, PhD Ghent University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01645475     History of Changes
Other Study ID Numbers: 2010/247
Study First Received: July 13, 2012
Last Updated: July 17, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
enuresis

Additional relevant MeSH terms:
Enuresis
Nocturnal Enuresis
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Mental Disorders Diagnosed in Childhood
Urination Disorders
Urologic Diseases
Deamino Arginine Vasopressin
Antidiuretic Agents
Cardiovascular Agents
Coagulants
Hematologic Agents
Hemostatics
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014