study of the pharmacokinetics and pharmacodynamics of desmopressin oral lyophilisate - route of administration in the pediatric patient population - SAFEPEDRUG

Phase 1

• Conditions: therapeutic population: monosympthomatic enuresis nocturnadiagnostic population: children with a history of a urinary tract infection or suspicion of renal damage who need a renal concentration test; Therapeutic area: Body processes [G] - Biological Phenomena [G16]

• Registration Number: EUCTR2014-005200-13-BE
• Lead Sponsor: Ghent University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-11
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

-children with uro-nephropathy who need a renal concentration test, or children with monosympthomatic enuresis nocturna and nightly polyuria with lack of efficacy of desmopressin tablet
-healthy children (cfr medical history and clinical examination)
-informed consent voluntary signed by the parents or legal guardian
-age between 6 months and 8 years
-minimum weight of 8 kg
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-diabetes insipidus (proven central diabetes insipidus)
-renal insufficiency (eGFR < 60ml/min/1,73m²)
-active urine tract infection (on day of testing, based on clinical data)
- SIADH (syndrome of inappropriate ADH-release),
-heart failure
-clinical significant disease (renal, hepatic, gastrointestinal, pulmonary, cardia, endocrinological or neurological) which could interfere with the evaluation of the end points
-hypersensitivity of desmopressin and/or the excipients of the lyophilisate (lactose monohydrate, potato starch, povidone, magnesium stearate)
-the use of antibiotics, diuretics or other medicines (like tricyclic antidepressants, chlorpropamide, oxcarbazepine, selective serotonin reuptake inhibitors, chlorpromazin and carbamazepine) which could influence the diuresis
-use of medication (like loperamide) which could influence the gastrointestinal motility
-abnormalities or diseases of the oral cavity which vould influence the release or absorption of the medication

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified