Skip to content

Trial · Interventional

CompletedPhase 4Registry data

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

Short name TM

NCTNCT01036841 (opens ClinicalTrials.gov in a new tab)Other id2009/653
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
24 participants (actual)
Sponsor
University Hospital, Ghent · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Belgium

Start
Dec 2009
Primary completion
Apr 2010
Completion
Apr 2010
First posted
21 Dec 2009 (estimated)
Last update posted
6 Feb 2019
Conditions
Enuresis · Polyuria

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 4

    TM

    NCT01036841

    Dec 2009 to Apr 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • desmopressin tabletDrug
  • desmopressin MELT formulationDrug

Arms2

  • Active comparator

    desmopressin tablet

  • Experimental

    desmopressin MELT-formulation

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Bioavailability of desmopressine MELT and tablet when taken with meal.

    Time frame · at 1h, 2h and 6h post adminstration

Secondary outcomes(1)

  1. Pharmacokinetic and pharmacodynamic for desmopressine MELT and tablet.

    Time frame · at 1h, 2h, 3h, 6h and 8h post administration

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 6 Years up to 16 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

PepBank is a research reference. Talk to a doctor before you use any peptide.