EUCTR2017-002169-23-DK
Active, Not Recruiting
Phase 1
The effect of clinical characterization of children with monosymptomatic nocturnal enuresis on the efficacy of desmopressin and alarm therapy. - DRYCHILD
Søren Rittig0 sites400 target enrollmentJune 30, 2017
ConditionsEnuresis nocturnaMedDRA version: 20.1Level: LLTClassification code 10014930Term: Enuresis (non-organic)System Organ Class: 100000004873Therapeutic area: Not possible to specify
DrugsMinirin
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Enuresis nocturna
- Sponsor
- Søren Rittig
- Enrollment
- 400
- Status
- Active, Not Recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age 6\-14 years.
- •2\. Three or more wet nights per week regarding the home registrations.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 400
- •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
- •1\. Ongoing constipation and/or faecal incontinence.
- •2\. Daytime symptoms such as urgency, frequency or incontinence.
- •3\. Recurrent urinary tract infections.
- •4\. Anamnestic, clinical or laboratory findings that can be related to diseases or conditions that might affect the parameters investigated.
- •5\. Neurological and/or known clinically significant anatomical abnormalities of the urinary tract.
- •6\. Former operations in the urinary tract.
- •7\. Prior or ongoing treatment with alarm, desmopressin or anticholinergics.
- •8\. Ongoing medication that may interfere with the parameters tested.
- •9\. Pregnant or lactating girl.
- •10\. Contra\-indications for the use of desmopressin: habitual or psychogenic polydipsia, use of diuretics, renal insufficiency, hyponatraemia or SIADH.
Outcomes
Primary Outcomes
Not specified
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