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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01036841
Recruitment Status : Completed
First Posted : December 21, 2009
Last Update Posted : May 26, 2011
Information provided by:
University Hospital, Ghent

Brief Summary:

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
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bedwetting

Arm Intervention/treatment
Active Comparator: desmopressin tablet Drug: desmopressin tablet
Administration of desmopressine tablet

Experimental: desmopressin MELT-formulation Drug: desmopressin MELT formulation
Administration of desmopressine MELT formulation

Primary Outcome Measures :
  1. Bioavailability of desmopressine MELT and tablet when taken with meal. [ Time Frame: at 1h, 2h and 6h post adminstration ]

Secondary Outcome Measures :
  1. Pharmacokinetic and pharmacodynamic for desmopressine MELT and tablet. [ Time Frame: at 1h, 2h, 3h, 6h and 8h post administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01036841

University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Principal Investigator: Johan Vande Walle, MD, PhD University Hospital Ghent, department of pediatric nephrology

Additional Information:
Responsible Party: MD. PhD Vande Walle, University hospital Ghent Identifier: NCT01036841     History of Changes
Other Study ID Numbers: 2009/653
First Posted: December 21, 2009    Key Record Dates
Last Update Posted: May 26, 2011
Last Verified: May 2011

Keywords provided by University Hospital, Ghent:
MNE with nocturnal polyuria
monosymptomatic nocturnal enuresis with nocturnal polyuria

Additional relevant MeSH terms:
Urinary Incontinence
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Deamino Arginine Vasopressin
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs