Short Stature children born small for Gestational Age (SGA) MedDRA version: 14.1 Level: LLT Classification code 10041093 Term: Small for gestational age System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Interventions
Trade Name: Genotropin
Product Name: Genotropin 5,3 mg
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Somatropin
Current Sponsor code: Genotropin
Concentration unit: mg/kg
Sponsors
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study: 1. Caucasian male or female subjects aged between 19-35 months at Screening Visit 1. 2. Signed and dated informed consent. 3. Born SGA (birth length and/or weight =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following will not be included in the study: 1. Severe Intra-Uterine Growth Retardation (IUGR) (birth length below - 4 SD for gestational age), if associated with dysmorphic features. 2. Severe prematurity (Gestational Age (GA) 0) based on at least 4 months measurement interval). 4. Severe familial short stature defined as: Father’s height below 155 cm or mother’s height below 145 cm. 5. Defined neurological defects and/or severe neurodevelopmental delay. 6. Defined syndromes such as fetal alcohol syndrome. 7. Severe perinatal complications like asphyxia, sepsis, Necrotizing Enterocolitis (NEC), respiratory distress syndrome, if associated with long-term sequelae (like short bowel syndrome, Broncho Pulmonary Dysplasia (BPD), cerebral palsy etc). 8. Other specific reason for short stature (eg, osteochondrodysplasia). 9. Any severe, acute or chronic illness (neurological, respiratory, gastrointestinal (eg, Coeliac disease etc) which in the opinion of the investigator may interfere with the interpretation of safety or efficacy evaluations. 10. Will be unlikely to comply with the protocol eg, inability to return for follow-up visits, or is unlikely to complete the study. 11. Is participating in any other studies involving investigational or marketed products. 12. Is currently treated with systemic glucocorticoids or has been treated with glucocorticoids for a period of one week or longer in the past 6 months. Topical or inhaled corticosteroids are permitted. 13. Subjects receiving other hormone treatment are not eligible for this study (except stable thyroid hormone replacement). 14. Any patient who meets any contraindication specified in the Genotropin Core Data Sheet, such as hypersensitivity to the active substance or to any of the excipients or any evidence of tumor activity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evalutate the efficacy of Genotropin® treatment on height SDS in short SGA children starting treatment at an age of 24-30 months as compared to untreated controls. ;Secondary Objective: The secondary objectives of this trial are to evaluate the effect of Genotropin® treatment on the overall mental and psychomotor development, body weight, body mass index (BMI) and head growth as compared to untreated controls as well as to demonstrate the safety of Genotropin® treatment in young short SGA children.;Primary end point(s): The primary endpoint will be the change from baseline in height SDS after 24 months of treatment. | — |
Countries
Austria, Czech Republic, France, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom
Contacts
Public ContactBernhard Saller
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, CT13 9NJ, UK
Outcome results
None listed