Desmopressin Response in the Young

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether desmopressin administered as a melt tablet is effective in reducing the number of wet nights in children and adolescents who suffer from bedwetting.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Deamino Arginine Vasopressin

Criteria

Inclusion Criteria:

• Children and adolescents (age 5-16 years) with diagnosed primary monosymptomatic nocturnal enuresis.

• A minimum of 3 wet nights per week in the 2-week screening period without treatment.

Exclusion Criteria:

• Presence or a history of organic urological disease, diurnal urinary incontinence, polydipsia, diabetes insipidus, ongoing urinary tract infection, clinically significant renal, hepatic, gastrointestinal, pulmonary, cardiovascular, endocrinological or neurological disease that would interfere with evaluation.

• Ongoing systemic antibiotic use, use of diuretics or any drugs affecting urinary concentration, or medical treatment for hyperactivity.

• Usage of any experimental drug or device during 30 days before study entry.