Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation (TM)
Primary Purpose
Enuresis, Polyuria
Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
desmopressin tablet
desmopressin MELT formulation
Sponsored by
About this trial
This is an interventional treatment trial for Enuresis focused on measuring MNE with nocturnal polyuria, monosymptomatic nocturnal enuresis with nocturnal polyuria
Eligibility Criteria
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
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
desmopressin tablet
desmopressin MELT-formulation
Arm Description
Outcomes
Primary Outcome Measures
Bioavailability of desmopressine MELT and tablet when taken with meal.
Secondary Outcome Measures
Pharmacokinetic and pharmacodynamic for desmopressine MELT and tablet.
Full Information
NCT ID
NCT01036841
First Posted
December 17, 2009
Last Updated
February 4, 2019
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT01036841
Brief Title
Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation
Acronym
TM
Official Title
Influence of Food-intake on Pharmacokinetic and Pharmacodynamic Parameters of Desmopressin Oral Tablet Formulation, in Comparison With Desmopressin MELT Formulation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enuresis, Polyuria
Keywords
MNE with nocturnal polyuria, monosymptomatic nocturnal enuresis with nocturnal polyuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
desmopressin tablet
Arm Type
Active Comparator
Arm Title
desmopressin MELT-formulation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
desmopressin tablet
Intervention Description
Administration of desmopressine tablet
Intervention Type
Drug
Intervention Name(s)
desmopressin MELT formulation
Intervention Description
Administration of desmopressine MELT formulation
Primary Outcome Measure Information:
Title
Bioavailability of desmopressine MELT and tablet when taken with meal.
Time Frame
at 1h, 2h and 6h post adminstration
Secondary Outcome Measure Information:
Title
Pharmacokinetic and pharmacodynamic for desmopressine MELT and tablet.
Time Frame
at 1h, 2h, 3h, 6h and 8h post administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Vande Walle, MD, PhD
Organizational Affiliation
University Hospital Ghent, department of pediatric nephrology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation
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