Desmopressin Response in the Young (DRY)

Ferring

Status and phase: Completed; Phase 3

Conditions: Primary Nocturnal Enuresis

Treatments: Drug: placebo; Drug: desmopressin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00230594

FE992026, CLN 10.3.26

Details and patient eligibility

About

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.

Full description

Primary nocturnal enuresis (PNE), or bedwetting, is a common childhood urological disease. Factors contributing to nocturnal enuresis include nocturnal polyuria due to, at least in part, a relative deficiency of antidiuretic hormone arginine vasopressin (AVP) which has been supported by the finding that some enuretic children lack a nocturnal increase in endogenous AVP secretion. Desmopressin, a synthetic, structural analogue of AVP, selective for V2-receptors and with a longer half life than the natural hormone, has been found to be especially beneficial in PNE subjects with nocturnal polyuria and normal functional bladder capacity.

A melt tablet formulation offers benefits compared to regular tablets and nasal spray. Regular tablets are more difficult to swallow for some patients and require fluid intake for swallowing. Nasal spray absorption may be altered by seasonal allergies, upper respiratory infections or improper administration.

Enrollment: 132 patients

Sex: All

Ages: 5 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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132 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

desmopressin

Treatment:

Drug: desmopressin

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo