One-Year Data from a Long-Term Phase IV Study of Recombinant Human Growth Hormone in Short Children Born Small for Gestational Age.

Background: This prospective, open-label, non-comparative, multicentre, long-term phase IV study is examining the efficacy and safety of somatropin [recombinant human growth hormone (rhGH)] in short children born small for gestational age (SGA) and its impact on the incidence of diabetes. This report is the first interim analysis of patients who have completed 1 year of treatment.

Methods: A total of 278 pre-pubertal patients were enrolled.

Long-term safety and efficacy of the recombinant human growth hormone Omnitrope® in the treatment of Spanish growth hormone deficient children: results of a phase III study.

Introduction: This phase III study in growth hormone (GH) deficient (GHD) children with growth retardation was designed to demonstrate the safety and efficacy of longterm treatment with the recombinant human GH Omnitrope® (Sandoz BioPharmaceuticals, Holzkirchen, Germany).

Methods: Treatment-naïve, prepubertal Spanish children (n=70) with isolated GHD were treated with Omnitrope 0.03 mg/kg/day subcutaneously.

Seven years of safety and efficacy of the recombinant human growth hormone Omnitrope in the treatment of growth hormone deficient children: results of a phase III study.

Aim: This phase III clinical study in growth hormone deficiency (GHD) children with growth retardation was designed to compare efficacy and safety of Omnitrope((R)) with Genotropin((R)) and assess the long-term safety and efficacy of Omnitrope((R)). The results of 7 years of treatment with Omnitrope((R)) are presented.

Patients And Methods: Eighty-nine treatment-naïve, prepubertal children with GHD were randomized (part 1) to Omnitrope((R)) lyophilisate (group A, n = 44) or Genotropin((R)) (group B, n = 45) for 9 months and received a subcutaneous dose of 0.

Children in clinical trials: survey on the current situation in paediatric university clinics in Germany.

Many prescribed treatments for children have not been adequately tested in children, sometimes resulting in harmful treatments being given and beneficial treatments being withheld. In the absence of specific trial-based data in children, results of studies in adults are extrapolated, which is often inappropriate because children have different range of diseases and metabolize medications differently. Trials in children are more challenging than those in adults and the pool of eligible children entering trials is often small.

The effect of anti-L-selectin (aselizumab) in multiple traumatized patients--results of a phase II clinical trial.

Objective: The objectives of this study were to evaluate safety (primary) and clinical efficacy (secondary) of the humanized monoclonal anti-L-selectin antibody aselizumab in severely injured patients.

Design: Prospective phase II, parallel group, double-blind, randomized, placebo-controlled clinical trial.

Setting: Fourteen medical intensive care units or trauma units in level I trauma centers in Belgium, Germany, and Poland.