Dettagli per singolo studio

DEC-NET Serial number GB314

Published online	06/09/2004 12.30.00
Last updated	10/10/2005 13.00.03


This trial has been approved by an ethics committee
Current trial status	Complete(closed to recruitment of participants: follow-up complete)
Target N. of subjects	N/A
Major Disease (ICD9 class)	PITUITARY DWARFISM
Gender	Both
Age (range)	3-18 years
Eligibility criteria
Inclusion criteria
Growth retardation due to insufficient endogenous growth hormone secretion Attendance at out patients clinic parents (and children where appropriate) giving informed consent
Exclusion criteria
Children who refuse to follow the regime
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Controlled
Purpose of study
Different preparations of somatropin or rhGH (Humatrope®, Zomacton®, Genotropin®, Norditropin®, Saizen®), produced by recombinant DNA technology using Esherichia coli or mammalian cells, are currently used to treat growth hormone deficient children. All these preparations have equovalent therapeutic efficacy and pharmacokinetic properties. A daily dose of 0.03 mg/kg body weight (0.10 IU/kg) by subcutaneous injection is recommended in the treatment of children with growth hormone deficiency. Biochemie GmbH has recently developed a new rhGH (Omnitrop®), also manufactured by recombinant DNA technology, which is suitable for administration in man. The aim of this present study is to evaluate the long-term safety and efficacy of a formulation of Omnitrop® (r-hGH) in the target population and to assess the frequency of hGH antibody development. The primary objective is to evaluate the long-term efficacy in terms of height, HSDS, height velocity, HVSDS and safety of Omnitrop® (r-hGH) in the treatment of growth retardation in GHD children. The secondary objectives are to evaluate in GHD children IGF-1, IGFBP-3 serum levels after the administration of Omnitrop® (r-hGH).
Primary outcomes
Development of height.
Secondary outcomes
Changes in IGF-1 and IGFBP-2 serum levels from baseline to 3,6,9 and 12 months.
Summary of study design, objectives, and ongoing research findings
A non-randomised controlled trial to evaluate the long term efficacy and safety of a formulation of omnitrop (somatropin) in the treatment of growth retardation in children with insufficient endogenous growth hormone secretion.