The Effect of Melatonin on Nocturnal Enuresis | NCT01575678

Studies
The Effect of Melatonin on Nocturnal Enuresis

NCT01575678

Sponsor

University of Aarhus

Status

Unknown status

Last Update Posted

Nov 2, 2012Estimated

Enrollment

40Estimated

Phase

Phase 2

Conditions

Nocturnal Enuresis

Interventions

Melatonin
Lactose

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-004138-33	EudraCT Number

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Aug 2013Estimated

Completion Date

Aug 2013Estimated

First Submitted Date

Feb 24, 2012

First Submission Date that Met QC Criteria

Apr 10, 2012

First Posted Date

Apr 11, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2012

Last Update Posted Date

Nov 2, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Aim: To investigate the effect of melatonin in bedwetting.

Detailed Description

Design: Double blind randomized placebocontrolled trial using crossover.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Melatonin	Active Comparator		Drug: Melatonin
Lactose	Placebo Comparator		Drug: Lactose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Melatonin	Drug	blinded capsule 2-4 mg/day, oral use, for 4 weeks	Melatonin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of incontinence episodes		10 weeks

Secondary Outcomes

Measure	Description	Time Frame
nocturnal blood pressure	Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.	4 weeks
activity level	Time frame: Week 1: Baseline. Week 5: Effect of 1st treatment arm. Week 6: Wash out. Week 10: Effect of 2nd treatment arm.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Søren Rittig, MD, dr.med, professor	Contact			rittig@ki.au.dk
Britt Borg, MS	Contact	+4578451523		bborg@ki.au.dk

Overall Officials

Name	Affiliation	Role
Søren Rittig, MD, dr.med	Pediatric department, Aarhus Universityhospital, Denmark	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Center of Child Incontinence, Pediatric department, Aarhus Universityhospital	Recruiting	Aarhus	Central Jutland	8200	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32364251	Derived	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.

ID	Term
D053206	Nocturnal Enuresis
D004775	Enuresis
D009043	Motor Activity

ID	Term
D014555	Urination Disorders
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D014363	Tryptamines
D007211	Indoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring