A Phase 4 interventional study of desmopressin tablet and desmopressin MELT formulation in Enuresis and Polyuria, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2019-02-06.
Sponsored by University Hospital, Ghent · Phase 4, Interventional, and Treatment
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.
31 studies on the registry are indexed under Enuresis; 2 are open to participants now.
This study's enrollment of 24 is below the median of 52 across 20 interventional studies indexed under Enuresis.
Browse Enuresis studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Drug: desmopressin tablet
Drug: desmopressin MELT formulation
Administration of desmopressine tablet
Administration of desmopressine MELT formulation
Bioavailability of desmopressine MELT and tablet when taken with meal.
Time frame: at 1h, 2h and 6h post adminstration
Pharmacokinetic and pharmacodynamic for desmopressine MELT and tablet.
Time frame: at 1h, 2h, 3h, 6h and 8h post administration
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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