Overview

A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

Status:
Completed
Trial end date:
2016-01-04
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in Europe and Asia. The aim of the trial is to compare the safety of once weekly dosing of somapacitan (administered with an investigational pen) with daily Norditropin® FlexPro® (somatropin delivered within a prefilled pen) for 26 weeks in previously human growth hormone (hGH) treated adults with growth hormone deficiency.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Hormones
Criteria
Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years
of age at the time of signing informed consent - Adult growth hormone deficiency diagnosed
for 6 months or longer (defined as 180 days) prior to screening - Treatment with hGH (human
growth hormone) for at least 6 months at screening - If applicable, hormone replacement
therapies for any other hormone deficiencies, adequate and stable for at least 90 days
prior to randomisation as judged by the investigator Exclusion Criteria: - Active malignant
disease or history of malignancy. Exceptions to this exclusion criterion: Resected in situ
carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete
local excision. / Subjects with GHD (growth hormone deficiency) attributed to treatment of
intracranial malignant tumours or leukaemia, provided that a recurrence-free survival
period of at least 5 years is documented in the subject's file - For patients with surgical
removal or debulking of pituitary adenoma or other benign intracranial tumour within the
last 5 years: Evidence of growth of pituitary adenoma or other benign intracranial tumour
within the last 12 months (defined as below or equal to 365 days) before randomisation.
Absence of growth must be documented by two post-surgery MRI or CT scans. The most recent
MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to
270 days) prior to randomisation