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Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation (TM)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01036841
First received: December 17, 2009
Last updated: May 25, 2011
Last verified: May 2011

December 17, 2009
May 25, 2011
December 2009
April 2010   (final data collection date for primary outcome measure)
Bioavailability of desmopressine MELT and tablet when taken with meal. [ Time Frame: at 1h, 2h and 6h post adminstration ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01036841 on ClinicalTrials.gov Archive Site
Pharmacokinetic and pharmacodynamic for desmopressine MELT and tablet. [ Time Frame: at 1h, 2h, 3h, 6h and 8h post administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Enuresis
  • Polyuria
  • Drug: desmopressin tablet
    Administration of desmopressine tablet
  • Drug: desmopressin MELT formulation
    Administration of desmopressine MELT formulation
  • Active Comparator: desmopressin tablet
    Intervention: Drug: desmopressin tablet
  • Experimental: desmopressin MELT-formulation
    Intervention: Drug: desmopressin MELT formulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
April 2010
April 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • children aged 6-16 years old
  • with MNE and nocturnal polyuria
  • treated with desmopressin tablet, non or partial responders, for whom change to MELT formulation is indicated according to the international standard guidelines.

Exclusion Criteria:

  • history of urologic disease, diurnal urinary incontinence, diabetes insipidus, urinary tract infection, clinically significant disease
  • No systemic use of antibiotics, diuretics, other medication that influences urinary concentrating mechanism
  • abnormalities of oral mucosa which could influence drugrelease or absorption
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01036841
2009/653
No
MD. PhD Vande Walle, University hospital Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Johan Vande Walle, MD, PhD University Hospital Ghent, department of pediatric nephrology
University Hospital, Ghent
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP