A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
The study compares 2 medicines used for the treatment of children who are born small and who
 stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a
 day (the medicine doctors can already prescribe).

 Participants will either get somapacitan or Norditropin® - which treatment is decided by
 chance. Both participants and the study doctor will know which treatment the participants
 get. The study will last for 4 years. Participants will take either an injection once every
 week or once every day. Participants will have 9 clinic visits and will be in the study for 1
 year. The follow-up period is at least 30 days.
Inclusion Criteria:

 -  Pre-pubertal children, boys:

 1. age between 2.5 and 11.0 years at screening.

 2. testes volume below 4 ml.

 -  Pre-pubertal children, girls:

 1. age between 2.5 and 10.0 years at screening.

 2. Tanner stage 1 for breast development (no palpable glandular breast tissue).

 -  Born small for gestational age (birth length and/or weight below -2 standard deviation
 scores) (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.

 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.