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

Ghent University0 个研究点目标入组 24 人开始时间: 2015年6月11日最近更新: 2020年8月10日

试验速览

暂无简介。

•-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

•-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

发起方