A randomised, open-label, parallel-group, multi-centre trial comparing the efficacy and safety of 12 months treatment with one daily dose of ZOMACTON® to one daily dose of GENOTROPIN® in the treatment of children with idiopathic growth hormone deficiency

Ferring Pharmaceuticals A/S0 个研究点目标入组 138 人开始时间: 2009年6月3日最近更新: 2012年9月25日

适应症

试验速览

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•Inclusion criteria Pre-screening:
•1.Signed informed consent and obtained assent.
•2.Children aged = 3 years and not above 10 years for girls or 11 years for boys at the Pre-screening visit.
•3.A positive locally performed GH stimulation test (defined as peak plasma level of < 9 ng/mL or lower if so required by the country specific board(s)) prior to the Pre-screening visit.
•4.Height SDS < -2 SD of reference value for chronological age (CA)
•5.Height velocity SDSCA = 0 SD of reference value for at least 6 months prior to the Pre-screening visit
•6.Height recorded for at least 6 months but performed no more than 18 months before the Pre-screening visit.
•Inclusion criteria Screening:
•7.Reconfirmed signed informed consent and obtained assent
•8.The difference between CA-BA = 1.
•9.Idiopathic GH deficiency confirmed during the Pre-screening period by a standard GH stimulation test (defined as peak plasma level of < 9 ng/mL or lower if so required by the country specific board(s))
•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 Pre-screening:
•1.Any prior treatment with GH
•2.Any diagnosed or suspected syndrome (e.g. Silver-Russell, Turner’s or Seckel syndrome) which possibly could affect growth
•3.Any other diagnosed or suspected endocrine or metabolic disorder (e.g. Prader-Willi syndrome, diabetes mellitus or Cushing’s syndrome)
•4.Any diagnosed or suspected severe chronic disease
•5.Clinical signs of dysmorphic features, malformations or mental retardation
•6.Growth failure due to other disorders (emotional deprivation, severe chronic illness, malnutrition or chondrodysplasia)
•7.Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)
•8.Diagnosed malignant disease
•9.Any known hypersensitivity to somatropin or any of the excipients of ZOMACTON and GENOTROPIN.
•Exclusion criteria Screening:
•10.BA above 9 years in girls and above 10 years in boys (to exclude pubertal growth)
•11.Puberty Tanner Stage > I
•12.Weight < 12 kg at the Screening visit
•13.Closed epiphysis
•14.Any abnormal clinically significant lab results that requires further investigation
•15.Receipt of an investigational drug within the last 28 days preceding Screening or longer if considered to possibly influence the outcome of the current trial.

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