NCT01575678

Brief Summary

Aim: To investigate the effect of melatonin in bedwetting.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 2, 2012

Status Verified

November 1, 2012

Enrollment Period

1.6 years

First QC Date

February 24, 2012

Last Update Submit

November 1, 2012

Conditions

Nocturnal Enuresis

Keywords

enuresismelatonincircadian rhythmchildrenblood pressureurine productionactivitysleep

Outcome Measures

Primary Outcomes (1)

  • number of incontinence episodes

    10 weeks

Secondary Outcomes (4)

  • nocturnal blood pressure

    4 weeks

  • activity level

    4 weeks

  • bladder capacity

    4 weeks

  • nocturnal urine production

    4 weeks

Study Arms (2)

Melatonin

ACTIVE COMPARATOR
Drug: Melatonin

Lactose

PLACEBO COMPARATOR
Drug: Lactose

Interventions

MelatoninDRUG

blinded capsule 2-4 mg/day, oral use, for 4 weeks

Melatonin
LactoseDRUG

blinded capsule 1/day, oral use, for 4 weeks

Lactose

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of Child Incontinence, Pediatric department, Aarhus Universityhospital

Aarhus, Central Jutland, 8200, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 32364251DERIVED

MeSH Terms

Conditions

Nocturnal EnuresisEnuresisMotor Activity

Interventions

MelatoninLactose

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone AntagonistsDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Søren Rittig, MD, dr.med

    Pediatric department, Aarhus Universityhospital, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Søren Rittig, MD, dr.med, professor

CONTACT

rittig@ki.au.dk

Britt Borg, MS

CONTACT

+4578451523bborg@ki.au.dk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2012

First Posted

April 11, 2012

Study Start

January 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 2, 2012

Record last verified: 2012-11

Locations

DK(1)