Enuresis Clinical Trial
— TMOfficial title:
Influence of Food-intake on Pharmacokinetic and Pharmacodynamic Parameters of Desmopressin Oral Tablet Formulation, in Comparison With Desmopressin MELT Formulation
NCT number | NCT01036841 |
Other study ID # | 2009/653 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | December 2009 |
Est. completion date | April 2010 |
Verified date | February 2019 |
Source | University Hospital, Ghent |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 24 |
Est. completion date | April 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 16 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Ghent | Ghent |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bioavailability of desmopressine MELT and tablet when taken with meal. | at 1h, 2h and 6h post adminstration | ||
Secondary | Pharmacokinetic and pharmacodynamic for desmopressine MELT and tablet. | at 1h, 2h, 3h, 6h and 8h post administration |
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