NCT02699528

Brief Summary

To assess wether methylphenidate reduces the prevalence of primary nocturnal enuresis in children with attention deficit disorder

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 4, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

11 months

First QC Date

February 2, 2016

Last Update Submit

September 15, 2016

Conditions

Attention Deficit Hyperactivity DisorderEnuresis

Outcome Measures

Primary Outcomes (1)

  • A reduction in nocturnal enuresis frequency

    6 weeks

Interventions

methylphenidateDRUG

The drug will be prescribed as indicated for attention deficit disorder

Also known as: Ritalin, Concerta

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children aged 5 - 10 years receiving a new diagnosis of attention deficit hyperactivity disorder

You may qualify if:

  • New diagnosis of attention deficit hyperactivity disorder
  • History of primary nocturnal enuresis
  • Normal neurological examination

You may not qualify if:

  • Anatomical abnormality of the genitourinary system
  • Concommitant treatment, pharmacological/behavioral for enuresis
  • Concommitant diurnal enuresis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityEnuresis

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesBehavioral SymptomsBehaviorElimination Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nathan Watemberg, MD

    Meir Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Florence Katz, BA

CONTACT

972-9-7471803florence.katz@clalit.org.il

Omer Raviv, MD

CONTACT

972-52-8822052omerol@walla.co.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 2, 2016

First Posted

March 4, 2016

Study Start

May 1, 2016

Primary Completion

April 1, 2017

Study Completion

May 1, 2017

Last Updated

September 16, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)