Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2012-01-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Melatonin
Melatonin
blinded capsule 2-4 mg/day, oral use, for 4 weeks
Lactose
Lactose
blinded capsule 1/day, oral use, for 4 weeks
Interventions
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Melatonin
blinded capsule 2-4 mg/day, oral use, for 4 weeks
Lactose
blinded capsule 1/day, oral use, for 4 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
6 Years
14 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
Responsible Party
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Principal Investigators
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Søren Rittig, MD, dr.med
Role: PRINCIPAL_INVESTIGATOR
Pediatric department, Aarhus Universityhospital, Denmark
Locations
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Center of Child Incontinence, Pediatric department, Aarhus Universityhospital
Aarhus, Central Jutland, Denmark
Countries
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Central Contacts
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Facility Contacts
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Britt Borg, postgrad. medical student
Role: primary
References
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Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.
Other Identifiers
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2011-004138-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EnuMel-11
Identifier Type: -
Identifier Source: org_study_id