The effect of melatonin on bedwetting

Phase 1

• Conditions: nocturnal enuresis; MedDRA version: 16.0 Level: LLT Classification code 10029453 Term: Nocturnal enuresis System Organ Class: 100000004857; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2011-004138-33-DK
• Lead Sponsor: Søren Rittig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-12-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 40

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

- 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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified