Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation (TM)
|ClinicalTrials.gov Identifier: NCT01036841|
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : May 26, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Enuresis Polyuria||Drug: desmopressin tablet Drug: desmopressin MELT formulation||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Influence of Food-intake on Pharmacokinetic and Pharmacodynamic Parameters of Desmopressin Oral Tablet Formulation, in Comparison With Desmopressin MELT Formulation|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
|Active Comparator: desmopressin tablet||
Drug: desmopressin tablet
Administration of desmopressine tablet
|Experimental: desmopressin MELT-formulation||
Drug: desmopressin MELT formulation
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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01036841
|University Hospital Ghent|
|Ghent, Belgium, 9000|
|Principal Investigator:||Johan Vande Walle, MD, PhD||University Hospital Ghent, department of pediatric nephrology|