Short stature in children born small for gestational age with no catch-up growth by 2 years of age or older MedDRA version: 21.1 Level: LLT Classification code 10041093 Term: Small for gestational age System Organ Class: 100000004868
Conditions
Interventions
Product Name: somapacitan 5 mg/1.5ml PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: SOMAPACITAN
CAS Number: 1333578-34-9
Concentration unit: mg/ml milligram(s)/millilitre
Conc
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Pre-pubertal children: a) Boys: Age more than or equal to 2 years and 26 weeks and less than 11.0 years at screening. Testes volume less than 4 ml. b) Girls: Age more than or equal to 2 years and 26 weeks and less than 10.0 years at screening. Tanner stage 1 for breast development (no palpable glandular breast tissue) - Born small for gestational age (birth length and/or weight less than -2 standard deviation scores (SDS)) (according to national standards) - Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening - Impaired height velocity defined as annualised height velocity below the 50th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening - No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment Are the trial subjects under 18? yes Number of subjects for this age range: 60 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
Exclusion criteria: - Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements - Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise - Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening - Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 µg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening - Concomitant administration of other treatments that may have an effect on growth, e.g. but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder - Diagnosis of attention deficit hyperactivity disorder - Prior history or presence of malignancy including intracranial tumours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of somapacitan versus Norditropin® on longitudinal growth in children with short stature born small for gestational age with no catch-up growth by 2 years of age or older.;Secondary Objective: To evaluate the effect and safety of somapacitan versus Norditropin® in children born small for gestational age with no catch-up growth by 2 years or older.;Primary end point(s): Height velocity;Timepoint(s) of evaluation of this end point: From baseline (week 0) to visit 5 (week 13) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in bone age 2. Change in height SDS 3. Change in height velocity SDS 4. Change in fasting plasma glucose (FPG) 5. Change in homeostatic model assessment (HOMA) 6. Change in glycated haemoglobin (HbA1c) 7. Change in IGF-I SDS 8. Change in Insulin-like growth factor binding protein 3 (IGFBP-3) SDS;Timepoint(s) of evaluation of this end point: 1: From baseline (week 0) to visit 8 (week 52) 2: From baseline (week 0) to visit 6 (week 26) 3.: From baseline (week 0) to visit 6 (week 26) 4.: From screening (visit 1) to visit 6 (week 26) 5.: From screening (visit 1) to visit 6 (week 26) 6.: From screening (visit 1) to visit 6 (week 26) 7.: From baseline (week 0) to visit 6 (week 26) 8.: From baseline (week 0) to visit 6 (week 26) | — |
Countries
Algeria, Austria, Canada, Denmark, Estonia, European Union, France, Hungary, India, Ireland, Israel, Japan, Latvia, Norway, Poland, Russian Federation, Serbia, Spain, Switzerland, Thailand, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed