A Study of Zomacton in Children With Growth Hormone Deficiency
Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
This trial is set up to compare Zomacton to Genotropin for the treatment of growth hormone
deficiency in children. The children will be treated for 1 year. Half of the patients will be
treated with Genotropin and half with Zomacton. During this time they will be dosed every day
by themselves or their parents at home in the evening. There will be 138 patients in the
trial from age 3 to age 11. The patients cannot have been treated before with growth hormone
and the patients must have a proven growth hormone deficiency, this will be shown by a
specific test that will be performed before the trial in the local clinic and once during the
trial. During the time of the treatment the patients will come to visit the clinic every 3
months. At these visits their heights will be measured, blood samples will be taken, physical
examinations will be performed and questions about their health will be asked. At 2 times in
the trial they will have a hand x-ray taken to measure the bone age. At the end of the trial
the patients will stop the treatment and continue on one of the marketed products available
to treat growth hormone deficiency.