Nocturnal Enuresis. MedDRA version: 7.1 Level: LLT Classification code 10002774
Conditions
Interventions
16-
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Code: FE106483
Pharmaceutical Form: Tablet
INN or Proposed INN: Not applied for as yet
CAS Number: 347887-36-9
Current Sponsor code: FE106483
Concentration unit: mg milligram(s)
Concentration
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or female 6-17 years of age (both inclusive). Patients will be stratified into two age groups 6-11 and 12-17. 2.A minimum weight of 20 kg and body mass index (BMI) between 14 and 25 kg/m2 for patients aged 6-15 years and BMI between 18 and 25 kg/m2 for patients aged 16-17 years. 3.An average of ??3 wet nights per week as measured during any two-week period within the last 6 months. 4.Documented capacity to concentrate their urine above 800 mOsm/kg. 5.Serum sodium concentration above the lower limit of normal at the Screening Visit (analysed at the investigational site). 6.Capable of swallowing a tablet. 7.Otherwise healthy according to medical history and physical examination. 8.Written informed consent, provided by the parents or legal guardian to the child, prior to any study-related procedures. (In addition, the child should personally sign and date the consent form when judged to be of appropriate intellectual maturity.) Are the trial subjects under 18? yes Number of subjects for this age range: 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
Exclusion criteria: 1.Known or suspected clinically significant cardiovascular disease including cardiac surgery, marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval ? 450 msec) and a history of additional risk factors for Torsade de Pointes ventricular arrhythmias (e.g. heart failure, hypokalemia, family history of Long QT syndrome) 2.The use of concomitant medications that prolong the QT/QTc interval. 3.Diabetes mellitus type I and II 4.Clinically significant renal or hepatic disease or bladder abnormality 5.Daytime urinary incontinence (?1 episode a week). 6.Positive urine stick for blood, leucocytes, proteins, glucose, ketones or nitrite. 7.Use of any concomitant medication within the last week prior to dosing. 8.Pregnant or breast-feeding. 9.Hypersensitivity to any of the components in the investigational medicinal product.* 10.Has received an investigational medicinal product within the last 12 weeks prior to the Screening Visit. 11.Previous participation in this study. 12.Other clinically significant laboratory abnormalities, which could interfere with the patient participation in this study, as judged by the investigator. 13.Clinically significant neurological, gastrointestinal, psychological, pulmonary, metabolic, endocrine, haematological, dermatological or infectious disorder, cancer or any other condition, which may interfere with trial participation or which may affect the conclusion of the study as judged by the investigator. 14.Mental incapacity or language barriers precluding adequate understanding or co-operation from the patient and/or the parents or legal guardian. *The investigational product contains lactose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the pharmacodynamic profile of 3 different dose levels of FE 106483 tablets in children with nocturnal enuresis.;Secondary Objective: •To investigate the pharmacokinetics of FE 106483. •To investigate the FE 106483 metabolite profile in plasma in children. •To investigate the frequency and severity of adverse events. •To investigate the effect of FE 106483 on laboratory values incl. serum-sodium and coagulation factors. •To investigate the effect of FE 106483 on ECGs and vital signs.;Primary end point(s): Duration of action, defined as the time that urinary osmolality remains above 200 mOsm/kg. | — |
Countries
Belgium
Outcome results
None listed