The Effect of Melatonin on Nocturnal Enuresis

Nocturnal Enuresis Clinical Trial

Official title:

The Effect of Melatonin on Nocturnal Enuresis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01575678
• Other study ID #: EnuMel-11
• Secondary ID: 2011-004138-33
• Status: Recruiting
• Phase: Phase 2
• First received: February 24, 2012
• Last updated: November 1, 2012
• Start date: January 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2012
• Source: University of Aarhus
• Contact: Søren Rittig, MD, dr.med, professor
• Email: rittig[@]ki.au.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

Aim: To investigate the effect of melatonin in bedwetting.

Description:

Design: Double blind randomized placebocontrolled trial using crossover.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enuresis
• Nocturnal Enuresis

Intervention

Drug:
• Melatonin
blinded capsule 2-4 mg/day, oral use, for 4 weeks
• Lactose
blinded capsule 1/day, oral use, for 4 weeks

Locations

Country	Name	City	State
Denmark	Center of Child Incontinence, Pediatric department, Aarhus Universityhospital	Aarhus	Region Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of incontinence episodes		10 weeks	No
Secondary	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	No
Secondary	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.	4 weeks	No
Secondary	bladder capacity	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	No
Secondary	nocturnal urine production	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	No