Evaluation of growth response in short children suffering from a disease with growth retardation and treated with Somatropin: A prospective, longitudinal non-randomised, open, phase II study
- Conditions
- Genotropin®) is approved for treatment of short statured children in specific indications. A benefit can also be achieved in other pathological conditions that lead to growth retardation. Because only few data or only case reports are available in these conditions improvement of growth rate should be shown by this study.
- Registration Number
- EUCTR2004-005223-18-DE
- Lead Sponsor
- Childrens´ Hospital Erlangen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
Inclusion criteria for request of GH treatment:
Severe growth retardation (< -2,5 height SDS and annual growth velocity (HV- SDS): < 0 SD according to Reinken (1992) and parental adjusted target height < –1 SD according to Tanner (1986)
Chronological age > 4 and < 10 years, prepubertal children; for girls: Tanner breast stage B = 1, for boys: testis volume = 3 ml
Any disease which is NOT part of the registered indications for GH treatment in Germany
Written informed consent from both parents and from the patients if she/he is able to receive and understand the information
GH treatment requested by an expert in pediatric endocrinology
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 for request of GH treatment:
Participation in any other clinical study
Unable to follow the and/or comprehend the protocol ( e.g. severe mental retardation)
Previous history of intolerance or hypersensitivity to the study drug
History of malignancy
Chromosomal anomalies with increased risk for malignancy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Primary: To show an improvement of height, change in height (SDS) under GH treatment one year after visit 2 (start of GH therapy).<br><br>;Secondary Objective: Secondary: To show an increase in height velocity >1 SD compared to pretreatment height velocity and to confirm good clinical and biological safety of GH treatment in these patients (e.g. adverse events, serum IGF-I, fasting blood glucose and insulin).<br>;Primary end point(s): Primary Efficacy Variable: Increase in height (SDS)<br><br>Secondary Efficacy Variable: height velocity (SDS) and safety on GH treatment<br>
- Secondary Outcome Measures
Name Time Method