Enuresis Clinical Trial
Official title:
Influence of Food-intake on Pharmacokinetic and Pharmacodynamic Parameters of Desmopressin Oral Tablet Formulation, in Comparison With Desmopressin MELT Formulation
Alarm-treatment as well as Desmopressin, a synthetic analogue of human vasopressin, are
considered the only evidence-based medicine (EBM) IA treatments in monosymptomatic nocturnal
enuresis (MNE). Desmopressin exists in three different formulations for ambulant use: nasal
spray, tablet and lyophilisate (MELT) each with differences in bioavailability (spray 2%,
tablet 0.2%, MELT 0.5%). There 's insufficient evidence to confirm the actually used
bioequivalent doses ( 10µg spray = 120µg MELT= 0.2mg tablet).
Although so frequently used, very few pharmacokinetic and -dynamic data on desmopressin are
available for children.
Due to prolonged half life, associated with waterintoxication,the nasal spray has a black box
warning from the FDA and is no longer recommended . For some authors oral formulations appear
to be a safer alternative. However, based on clinical experience of less response rate with
oral formulations, lower biodisponibility is suspected. Adult research confirms low
bioavailability of tablets but also show major influences by food-intake and changes in
gastro-intestinal motility.
To achieve maximum efficacy, recommendations are to take desmopressin tablet 1 hour before
bedtime and 2 hours after meal: this is unrealistic in schoolaged children since there never
is 3 hours between evening meal and bedtime.
In 2005 a dose response study demonstrated superior pharmaco-kinetic and dynamic properties
for desmopressin Lyophilisate MELT formula.
Since these results implicate superior action of MELT, often a change to MELT is recommended
if there is a suboptimal response with tablet: sublingual absorption would eliminate the
influence of food-intake.
However, for this statement there's no evidence, since these tests were all conducted in
children in fasting condition. Only one clinical study demonstrates bioequivalence for MELT
and tablet.
Hypothesis is that desmopressin MELT formulation has a better bioavailability when
administered together with meal due to its sublingual absorption.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02600676 -
Transcutaneous Electric Nerve Stimulation (TENS) in Children With Enuresis
|
N/A | |
Completed |
NCT02369445 -
Investigation of Teacher-Mediated Toilet Training Using a Manualized Moisture Alarm Intervention
|
N/A | |
Completed |
NCT01978210 -
Development of a Manualized Wireless Moisture Pager Intervention for Teaching Toileting in Children With Autism
|
N/A | |
Recruiting |
NCT06070675 -
Comparison of a Paper and Automated Bladder Diary in Pediatric Patients
|
N/A | |
Completed |
NCT01747343 -
Toilet Training Toddlers and Preschoolers
|
N/A | |
Recruiting |
NCT00437528 -
Safety and Applicability Study of a Novel Heat Flow Sensor Unit for Measuring Urinary Bladder Capacity
|
Phase 1 | |
Recruiting |
NCT02699528 -
The Effect of Methylphenidate on Primary Enuresis in Children With Attention Deficit Hyperactivity Disorder
|
N/A | |
Withdrawn |
NCT01861145 -
Intranasal Steroids for the Treatment of Nocturnal Enuresis With Associated Obstructive Sleep Apnea
|
Phase 4 | |
Completed |
NCT04260646 -
Alarm Treatment for Combined Enuresis and Daytime Urinary Incontinence in Children
|
N/A | |
Completed |
NCT00270621 -
Family Help Program: Nighttime Enuresis Treatment Program
|
Phase 2 | |
Completed |
NCT01367080 -
A Study to Compare the Pharmacokinetic Profiles of Etravil® Tablet 10mg and Etravil® Tablet 25mg
|
Phase 1 | |
Completed |
NCT00226122 -
The Effect of Indomethacin in Monosymptomatic Enuresis Nocturnal
|
Phase 4 | |
Completed |
NCT05190601 -
Uroflowmetry in Children With Enuresis Nocturnal
|
||
Withdrawn |
NCT03478813 -
Voiding School as a Treatment of Children's Day-time Incontinence or Enuresis
|
N/A | |
Recruiting |
NCT03399877 -
A Study on Accuracy Improvement of Repeated Measure Uroflowmetry- Electromyography
|
N/A | |
Active, not recruiting |
NCT06185361 -
Selective Serotonin Reuptake Inhibitors, Fluoxetine Versus the Standard Oral Desmopressin for Management of Mono-symptomatic Nocturnal Enuresis.
|
N/A | |
Completed |
NCT04280887 -
MyPad - Intelligent Bladder Pre-void Alerting System
|
N/A | |
Completed |
NCT00240812 -
A Study to Determine if Ibuprofen in Combination With Pseudoephedrine HCl is More Effective Than Each Drug Alone in the Treatment of Nighttime Bedwetting
|
Phase 2 |