Influence of Food-intake on Desmopressin Oral Tablets and MELT-formulation (TM)
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Enuresis Polyuria |
Drug: desmopressin tablet Drug: desmopressin MELT formulation |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: 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 |
- Bioavailability of desmopressine MELT and tablet when taken with meal. [ Time Frame: at 1h, 2h and 6h post adminstration ] [ Designated as safety issue: No ]
- Pharmacokinetic and pharmacodynamic for desmopressine MELT and tablet. [ Time Frame: at 1h, 2h, 3h, 6h and 8h post administration ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | December 2009 |
| Study Completion Date: | April 2010 |
| Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: desmopressin tablet |
Drug: desmopressin tablet
Administration of desmopressine tablet
|
| Experimental: desmopressin MELT-formulation |
Drug: desmopressin MELT formulation
Administration of desmopressine MELT formulation
|
Eligibility| Ages Eligible for Study: | 6 Years to 16 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Belgium | |
| University Hospital Ghent | |
| Ghent, Belgium, 9000 | |
| Principal Investigator: | Johan Vande Walle, MD, PhD | University Hospital Ghent, department of pediatric nephrology |
More Information
Additional Information:
No publications provided
| Responsible Party: | MD. PhD Vande Walle, University hospital Ghent |
| ClinicalTrials.gov Identifier: | NCT01036841 History of Changes |
| Other Study ID Numbers: | 2009/653 |
| Study First Received: | December 17, 2009 |
| Last Updated: | May 25, 2011 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Belgium: Institutional Review Board |
Keywords provided by University Hospital, Ghent:
|
MNE with nocturnal polyuria monosymptomatic nocturnal enuresis with nocturnal polyuria |
Additional relevant MeSH terms:
|
Enuresis Nocturnal Enuresis Polyuria Urination Disorders Urologic Diseases Behavioral Symptoms Elimination Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Urological Manifestations Signs and Symptoms |
Deamino Arginine Vasopressin Antidiuretic Agents Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Hemostatics Coagulants Hematologic Agents Therapeutic Uses Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 21, 2013