The Effect of Melatonin on Nocturnal Enuresis

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01575678
First received: February 24, 2012
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

Aim: To investigate the effect of melatonin in bedwetting.


Condition Intervention Phase
Nocturnal Enuresis
Drug: Melatonin
Drug: Lactose
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Melatonin on Nocturnal Enuresis

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • number of incontinence episodes [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • nocturnal blood pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Time frame:

    Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.


  • activity level [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Time frame:

    Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.


  • bladder capacity [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Time frame:

    Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.


  • nocturnal urine production [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    Time frame:

    Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.



Estimated Enrollment: 40
Study Start Date: January 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Melatonin Drug: Melatonin
blinded capsule 2-4 mg/day, oral use, for 4 weeks
Placebo Comparator: Lactose Drug: Lactose
blinded capsule 1/day, oral use, for 4 weeks

Detailed Description:

Design: Double blind randomized placebocontrolled trial using crossover.

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Monosymptomatic nocturnal enuresis
  • Age 6-14 years
  • Clinical examination normal
  • ≥ 3 wet nights / week due to either nocturnal polyuria with normal bladder size or reduced functional bladder capacity with normal urine output

Exclusion Criteria:

  • Constipation (by ROME III criteria)
  • Day incontinence
  • Overactive bladder (ICCS 2008 classification of symptoms)
  • Current or past history of clinical or laboratory findings that can be related to diseases or - conditions (eg pregnancy) likely to change the parameters examined, especially diseases of the kidney and urinary tract, liver or endocrine disorder.
  • Clinical signs of urinary tract infection
  • Hypertension, blood pressure assessed by ambulatory measurement with blood pressure cuff
  • Set treatment with one or more drugs
  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: NCT01575678

Contacts
Contact: Søren Rittig, MD, dr.med, professor rittig@ki.au.dk
Contact: Britt Borg, MS +4578451523 bborg@ki.au.dk

Locations
Denmark
Center of Child Incontinence, Pediatric department, Aarhus Universityhospital Recruiting
Aarhus, Region Midtjylland, Denmark, 8200
Contact: Britt Borg, postgrad. medical student    +45 78451523    bborg@ki.au.dk   
Sub-Investigator: Kostas Kamperis, MD, Ph.D         
Sub-Investigator: Birgitte Mahler, MD, Ph.D         
Sub-Investigator: Britt Borg, postgrad. medical student         
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Søren Rittig, MD, dr.med Pediatric department, Aarhus Universityhospital, Denmark
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01575678     History of Changes
Other Study ID Numbers: EnuMel-11, 2011-004138-33
Study First Received: February 24, 2012
Last Updated: November 1, 2012
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by University of Aarhus:
enuresis
melatonin
circadian rhythm
children
blood pressure
urine production
activity
sleep

Additional relevant MeSH terms:
Enuresis
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014