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The Effect of Melatonin on Nocturnal Enuresis

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ClinicalTrials.gov Identifier: NCT01575678
Recruitment Status : Unknown
Verified November 2012 by University of Aarhus.
Recruitment status was:  Recruiting
First Posted : April 11, 2012
Last Update Posted : November 2, 2012
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
Aim: To investigate the effect of melatonin in bedwetting.

Condition or disease Intervention/treatment Phase
Nocturnal Enuresis Drug: Melatonin Drug: Lactose Phase 2

Detailed Description:
Design: Double blind randomized placebocontrolled trial using crossover.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Melatonin on Nocturnal Enuresis
Study Start Date : January 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Melatonin
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. number of incontinence episodes [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. nocturnal blood pressure [ Time Frame: 4 weeks ]

    Time frame:

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


  2. activity level [ Time Frame: 4 weeks ]

    Time frame:

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


  3. bladder capacity [ Time Frame: 4 weeks ]

    Time frame:

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


  4. nocturnal urine production [ Time Frame: 4 weeks ]

    Time frame:

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




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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01575678     History of Changes
Other Study ID Numbers: EnuMel-11
2011-004138-33 ( EudraCT Number )
First Posted: April 11, 2012    Key Record Dates
Last Update Posted: November 2, 2012
Last Verified: November 2012

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

Additional relevant MeSH terms:
Enuresis
Urinary Incontinence
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants