The effect of melatonin on bedwetting

The effect of melatonin on nocturnal enuresis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004138-33-DK

Enrollment

Registered

2011-12-15

Start date

2011-12-23

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nocturnal enuresis MedDRA version: 16.0 Level: LLT Classification code 10029453 Term: Nocturnal enuresis System Organ Class: 100000004857

Interventions

Trade Name: Circadin Product Name: Circadin Pharmaceutical Form: Capsule INN or Proposed INN: melatonin CAS Number: 73-31-4

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age 6-14 years - Clinical examination normal - = 3 wet nights / week due to either nocturnal polyuria with normal bladder size or reduced daytime/nighttime bladder capacity with normal urine output -OR healthy control Are the trial subjects under 18? yes Number of subjects for this age range: 40 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effect of melatonin in fixed dosage before bedtime in children with monosymtomatic nocturnal enuresis on the number of wet nights per week compared with placebo.;Secondary Objective: To investigate melatonins mechanisms of action in children with monosymptomatic nocturnal enuresis, including on nocturnal urine production, nocturnal blood pressure level and nocturnal bladder capacity.;Primary end point(s): number of incontinence episodes;Timepoint(s) of evaluation of this end point: at the end of trial	—

Measure

Time frame

Main Objective: To investigate the effect of melatonin in fixed dosage before bedtime in children with monosymtomatic nocturnal enuresis on the number of wet nights per week compared with placebo.;Secondary Objective: To investigate melatonins mechanisms of action in children with monosymptomatic nocturnal enuresis, including on nocturnal urine production, nocturnal blood pressure level and nocturnal bladder capacity.;Primary end point(s): number of incontinence episodes;Timepoint(s) of evaluation of this end point: at the end of trial

—

Secondary

Measure	Time frame
Secondary end point(s): nocturnal blood pressure, Circadian level (activity and skin), decrease in nocturnal urine production and increased bladder capacity;Timepoint(s) of evaluation of this end point: at the end of trial	—

Countries

Denmark

Contacts

Public ContactBritt Borg

Aarhus University Hospital

britt.borg@studmed.au.dk004522740973

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026