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Pharmacokinetics and Pharmacodynamics of Desmopressin Oral Lyophilisate Formulation in the Paediatric Population

2015-10-23 14:08:22 | BioPortfolio

Summary

Patients suffering from nocturnal enuresis (starting from the age of 5 till adulthood) are all treated with the same dose of desmopressin, i.e. 120mcg once daily. In treatment resistant enuresis, this dose is doubled: those patients take 240mcg once daily. A pilot study performed at our department showed a correlation between weight and plasma concentration when a fixed dose of desmopressin oral lyophilisate formulation was given to the pediatric patient (older than 6 years). This study will investigate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmopressin in young children, less than 8 years old. Additionally, the efficacy of desmopressin oral lyophilisate formulation in urinary concentration testing will be evaluated

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Monosymptomatic Nocturnal Enuresis

Intervention

desmopressin

Location

Ghent University Hospital - Department of Paediatric Nephrology
Ghent
Belgium
9000

Status

Recruiting

Source

University Hospital, Ghent

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-10-23T14:08:22-0400

Clinical Trials [181 Associated Clinical Trials listed on BioPortfolio]

The Effect of Selecting Treatment With Desmopressin or Alarm to Children With Enuresis Based on Home Recordings.

The aim of this study is to investigate the importance of clinical characterization of children with monosymptomatic nocturnal enuresis (MNE) in order to improve treatment efficacy. ...

Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).

Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of all 7 year olds. MEN is often leading to psychosocial problems because of its burden and stigma...

Study With Two Different Doses of Desmopressin Melt Tablet With Nocturnal Enuresis

This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin lyophilisate f...

The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal

Monosymptomatic nocturnal enuresis, defined as the involuntary loss of urine during the night at an age where voluntary bladder control should have been attained and on the background of n...

Desmopressin as a Therapy for Bedwetting in Children With Sickle Cell Disease

This study assesses if using the medication desmopressin will decrease nightime bedwetting in children with sickle cell disease. Half of the children will receive placebo and half of the c...

PubMed Articles [154 Associated PubMed Articles listed on BioPortfolio]

Desmopressin, alarm, desmopressin plus alarm, and desmopressin plus anticholinergic agent in the management of pediatrics monosymptomatic nocturnal enuresis: a network meta-analysis.

To assess the efficacy of desmopressin (D), alarm (A), desmopressin plus alarm (DA), and desmopressin plus anticholinergic agent (DAA) in the management of pediatrics monosymptomatic nocturnal enuresi...

Enuresis Management in the Primary Care Pediatrics Clinic.

Enuresis is a frequent complaint not always volunteered by parents or patients. The pediatric clinician has to inquire about enuresis to break the secrecy surrounding this symptom that could be relate...

Primary nocturnal enuresis: a novel therapeutic strategy with higher efficacy.

To introduce a new protocol for patients with primary nocturnal enuresis to increase efficacy of treatment and decrease relapse rate.

A comprehensive review of adult enuresis.

Nocturnal enuresis (NE) is a combined symptom of nocturia and urinary incontinence. In this review, we aim to summarize the current literature on NE in terms of its definition, diagnosis, and manageme...

Relationship between nocturnal enuresis and poor sleep quality.

Sleep disorders are strongly associated with childhood nocturnal enuresis (NE). In this study, we examined whether sleep disorders are present in children with NE, and whether NE is caused by sleeping...

Medical and Biotech [MESH] Definitions

Involuntary discharge of URINE after expected age of completed development of urinary control. This can happen during the daytime (DIURNAL ENURESIS) while one is awake or during sleep (NOCTURNAL ENURESIS). Enuresis can be in children or in adults (as persistent primary enuresis and secondary adult-onset enuresis).

Involuntary discharge of URINE during sleep at night after expected age of completed development of urinary control.

Involuntary shock-like contractions, irregular in rhythm and amplitude, followed by relaxation, of a muscle or a group of muscles. This condition may be a feature of some CENTRAL NERVOUS SYSTEM DISEASES; (e.g., EPILEPSY, MYOCLONIC). Nocturnal myoclonus is the principal feature of the NOCTURNAL MYOCLONUS SYNDROME. (From Adams et al., Principles of Neurology, 6th ed, pp102-3).

Involuntary discharge of URINE during the daytime while one is awake.

An idiopathic syndrome characterized by one or more of the following; recurrent orofacial swelling, relapsing facial paralysis, and fissured tongue (lingua plicata). The onset is usually in childhood and relapses are common. Cheilitis granulomatosa is a monosymptomatic variant of this condition. (Dermatol Clin 1996 Apr;14(2):371-9; Magalini & Magalini, Dictionary of Medical Syndromes, 4th ed, p531)

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