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The Effect of Melatonin on Nocturnal Enuresis

This study is currently recruiting participants.
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
History of Changes

February 24, 2012
November 1, 2012
January 2012
August 2013   (final data collection date for primary outcome measure)
number of incontinence episodes [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01575678 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effect of Melatonin on Nocturnal Enuresis
The Effect of Melatonin on Nocturnal Enuresis

Aim: To investigate the effect of melatonin in bedwetting.

Design: Double blind randomized placebocontrolled trial using crossover.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Nocturnal Enuresis
  • Drug: Melatonin
    blinded capsule 2-4 mg/day, oral use, for 4 weeks
  • Drug: Lactose
    blinded capsule 1/day, oral use, for 4 weeks
  • Active Comparator: Melatonin
    Intervention: Drug: Melatonin
  • Placebo Comparator: Lactose
    Intervention: Drug: Lactose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
6 Years to 14 Years
No
Contact: Søren Rittig, MD, dr.med, professor rittig@ki.au.dk
Contact: Britt Borg, MS +4578451523 bborg@ki.au.dk
Denmark
 
NCT01575678
EnuMel-11, 2011-004138-33
Yes
University of Aarhus
University of Aarhus
Not Provided
Principal Investigator: Søren Rittig, MD, dr.med Pediatric department, Aarhus Universityhospital, Denmark
University of Aarhus
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP