The Effect of Melatonin on Nocturnal Enuresis

November 1, 2012 updated by: University of Aarhus
Aim: To investigate the effect of melatonin in bedwetting.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Design: Double blind randomized placebocontrolled trial using crossover.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Britt Borg, MS
  • Phone Number: +4578451523
  • Email: bborg@ki.au.dk

Study Locations

  • Denmark
    • Region Midtjylland
      • Aarhus, Region Midtjylland, Denmark, 8200
        • Recruiting
        • Center of Child Incontinence, Pediatric department, Aarhus Universityhospital
        • Contact:
          • Britt Borg, postgrad. medical student
          • Phone Number: +45 78451523
          • Email: bborg@ki.au.dk
        • Sub-Investigator:
          • Kostas Kamperis, MD, Ph.D
        • Sub-Investigator:
          • Birgitte Mahler, MD, Ph.D
        • Sub-Investigator:
          • Britt Borg, postgrad. medical student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Melatonin
Drug: Melatonin
blinded capsule 2-4 mg/day, oral use, for 4 weeks
Placebo Comparator: Lactose
Drug: Lactose
blinded capsule 1/day, oral use, for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of incontinence episodes
Time Frame: 10 weeks
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
nocturnal blood pressure
Time Frame: 4 weeks

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: 4 weeks

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
bladder capacity
Time Frame: 4 weeks

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
nocturnal urine production
Time Frame: 4 weeks

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Søren Rittig, MD, dr.med, Pediatric department, Aarhus Universityhospital, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

August 1, 2013

Study Completion (Anticipated)

August 1, 2013

Study Registration Dates

First Submitted

February 24, 2012

First Submitted That Met QC Criteria

April 10, 2012

First Posted (Estimate)

April 11, 2012

Study Record Updates

Last Update Posted (Estimate)

November 2, 2012

Last Update Submitted That Met QC Criteria

November 1, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EnuMel-11
  • 2011-004138-33 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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