Nocturnal EnuresisPhase 2NCT01575678
The Effect of Melatonin on Nocturnal Enuresis
A Phase 2 study testing Melatonin and Lactose in people with Nocturnal Enuresis, run by University of Aarhus at 1 site in Denmark.
Trial summary
Aim: To investigate the effect of melatonin in bedwetting. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Nocturnal Enuresis
- What is being tested?
- Melatonin and Lactose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Søren Rittig, MD, dr.med, professor contact
Denmark1 site, 1 recruiting
- Recruiting
Center of Child Incontinence, Pediatric department, Aarhus Universityhospital
Aarhus, Central Jutland, 8200
Britt Borg, postgrad. medical student, +45 78451523, bborg@ki.au.dk
Kostas Kamperis, MD, Ph.D
About this study
Aim: To investigate the effect of melatonin in bedwetting.
Read the detailed description
Design: Double blind randomized placebocontrolled trial using crossover.
- Conditions
- Nocturnal Enuresis
- Being tested
- Melatonin, Lactose
- Keywords
- enuresis, melatonin, circadian rhythm, children, blood pressure, urine production, activity, sleep
- Medical subject headings
- Nocturnal Enuresis, Enuresis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
blinded capsule 2-4 mg/day, oral use, for 4 weeks
LactoseDrug
blinded capsule 1/day, oral use, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Melatonin | Active comparator | Not described Receives: Drug: Melatonin |
| Lactose | Placebo comparator | Not described Receives: Drug: Lactose |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of incontinence episodes
Measured: 10 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nocturnal EnuresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Søren Rittig, MD, dr.med, Principal investigator, Pediatric department, Aarhus Universityhospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575678
- Sponsor's protocol ID
- EnuMel-11
- Other IDs
- 2011-004138-33
- Status last verified
- Nov 2012
- First submitted
- 24 Feb 2012
- Last updated
- 2 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32364251
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Melatonin on Nocturnal Enuresis
- ClinicalTrials.gov ID
- NCT01575678
- Acronym / sponsor ID
- EnuMel-11
- Conditions
- Nocturnal Enuresis
- Keywords
- enuresis, melatonin, circadian rhythm, children, blood pressure, urine production, activity, sleep
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: To investigate the effect of melatonin in bedwetting.
Detailed description
Design: Double blind randomized placebocontrolled trial using crossover.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Melatonin | Active comparator | Drug: Melatonin |
| Lactose | Placebo comparator | Drug: Lactose |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatoninblinded capsule 2-4 mg/day, oral use, for 4 weeks | Drug | Melatonin |
| Lactoseblinded capsule 1/day, oral use, for 4 weeks | Drug | Lactose |
Primary outcome
number of incontinence episodes
Time frame: 10 weeks
4 secondary outcomes
nocturnal blood pressure
Time frame: 4 weeks
activity level
Time frame: 4 weeks
bladder capacity
Time frame: 4 weeks
nocturnal urine production
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2012.
- Derived from this study: PubMed 32364251Caldwell 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.
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Effectiveness of Individualized Pelvic Floor Muscle Rehabilitation in Addition to Standard Urotherapy and Alarm Therapy in Children With Primary Monosymptomatic Nocturnal Enuresis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Søren Rittig, MD, dr.med, professor contact
Søren Rittig, MD, dr.med principal investigator
Pediatric department, Aarhus Universityhospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Melatonin and Lactose in people with Nocturnal Enuresis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Søren Rittig, MD, dr.med, professor (rittig@ki.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of incontinence episodes (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01575678, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2012.