Eine Studie, in der die Wirkung und Sicherheit der einmal wöchentlichen Dosierung von Somapacitan mit dem täglich verabreichten Norditropin® bei Kindern mit Wachstumshormonmangel verglichen wird.

Product Name: somapacitan 5 mg/1.5ml PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: somapacitan
CAS Number: 1338578-34-9
Other descriptive name: SOMAPACITAN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 3.3-

Product Name: somapacitan 10 mg/1.5ml PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: somapacitan
CAS Number: 1338578-34-9
Other descriptive name: SOMAPACITAN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.7-

Product Name: somapacitan 15 mg/1.5ml PDS290
Pharmaceutical Form: Solution for injection
INN or Proposed INN: somapacitan
CAS Number: 1338578-34-9
Other descriptive name: SOMAPACITAN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 10-

Trade Name: Norditropin FlexPro 10 mg/1.5 ml
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Somatropin
CAS Number: 12629-01-5
Other descriptive name: SOMATROPIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6.7-

Gender:
Female: yes
Male: yes

Inclusion criteria:
- Prepubertal children:
- Boys:
- Age greater than or equal to 2 years and 26 weeks and less than 11.0 years at screening
- Testis volume less than 4 mL
- Girls:
- Age greater 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)
- Confirmed diagnosis of growth hormone deficiency determined by two different growth hormone stimulation tests performed within 12 months prior to randomisation, defined as a peak growth hormone level of less than or equal to 10.0 ng/mL using the world health organisation (WHO) International Somatropin 98/574 standard
- Impaired height defined as at least 2.0 standard deviations below the mean height for chronological age and gender at screening according to the standards of Center for Disease Control and Prevention
- Impaired height velocity, defined as annualised height velocity below the 25th 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
- Insulin-like Growth Factor-I (IGF-I) less than -1.0 Standard Deviation Score at screening, compared to age and gender normalized range measured at central laboratory
- No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I treatment
Are the trial subjects under 18? yes
Number of subjects for this age range: 192
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:
- Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements
- 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 ?g/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
- Diagnosis of attention deficit hyperactivity disorder
- 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
- Prior history or presence of malignancy including intracranial tumours