TO SHORT PREPUBERTAL CHILDREN BORN SMALL FOR GESTATIONAL AGE
Conditions
Interventions
Trade Name: Genotropin 5 mg and 12 mg
Genotropin MiniQuick 0.2-2.0mg
Product Name: Genotropin
Pharmaceutical Form: Powder and solvent for solution for injection
Sponsors
Pfizer AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Confirmed diagnosis of SGA: Gestational age known and ³30 weeks and birth weight and/or length =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Complicating disease, other than correctly treated hypothyroidism, such as celiac disease, neurological disease, hepatic disease, heart or renal failure, dyschondroplacias. Definition of complicating disease as judged by the Investigator. Past or ongoing malignant disease. - Diabetes mellitus Type I, Type II, or OGTT results abnormal at baseline - Concomitant syndromes (i.e. Turner syndrome verified by chromosomal analysis in girls and other syndromes such as bird headed syndrome, Noonan syndrome verified by photo at screening) other than Silver-Russell’s syndrome. - No height catch-up defined as 0 or negative difference between two repeated (first and second) height SDS measurements. Measurements must be performed within 5 and 7 months using the appropriate Swedish population based reference Karlberg 2002. Note; the subject must be at least 2,0 years old at the first measurement - Prior treatment with GH. - Unwillingness to participate in the trial, unable and/or unlikely to comprehend and/or follow the protocol or expected non-compliance - Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry into the study. - Chronic oral glucocorticoid treatment, inhalation steroids (i.e. budesonid > 400 ug or fluticason >200ug)and treatment with hormones other than levothyroxin. - MHP SDS – Height SDS > - 1 SDS screening. - Pubertal signs: girls = Tanner breast stage >B1; boys: Prader testicular volume ³3 mL. - Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results, and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if an individualized dose is superior to the fixed dose in height catch-up expressed as DIFF SDS after 36 months of treatment.;Secondary Objective: To evaluate - if an individualized dose of somatropin is as safe as the approved fixed standard dose with regard to carbohydrate metabolism, expressed as an abnormal oral glucose tolerance test (OGTT), after 36 months of treatment. - if an individualized dose of somatropin is as safe as the approved fixed standard dose with regard to insulin levels. - if an individualized dose is superior to the fixed dose in height catch-up expressed as DIFF SDS after 12 and 24 months of treatment. - the safety of an individualized dose as compared to a fixed standard dose with regard to lipid metabolism, body composition, standard laboratory tests, blood pressure and the occurrence of adverse events. - the difference between individualized and fixed dosing regimens with regard to change in height. - if there is a difference in the risk/benefit balance for increased risk of abnormal oral glucose tolerance test (OGTT) vs. improved height catch-up between the two treatment regimens.;Primary end point(s): - Change from baseline to 36 months in the DIFF SDS (MPH SDS-Height SDS ) | — |
Countries
Sweden
Outcome results
None listed