Status:
COMPLETED
A Study of Zomacton in Children With Growth Hormone Deficiency
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Growth Hormone Deficiency
Eligibility:
All Genders
3-11 years
Phase:
PHASE3
Brief 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 Ge...
Eligibility Criteria
Inclusion
- Signed informed consent
- Children aged ≤3yrs old and not above 10 yrs for girls or 11 yrs for boys
- Idiopathic growth hormone deficiency confirmed during the pre-screening period by a standard GH stimulation test (defined as peak level of \<10ng/ml pr lower if so required by the country specific board(s)
- Height SDS \<-2 SD of ref value for CA
- Height velocity SDSCA ≤ 0 SD of ref value for at lease 6 months prior to pre-screening
- Height recorded for at least 6 months but not more than 18 months of pre-screening
- The difference between CA-BA≥ 1
- A positive locally performed GH stimulation test (defined as a peak plasma level of\<9ng/ml or lower if so required by the country specific board(s)) prior to the pre-screening
Exclusion
- BA above 9 yrs for girls and 10 yrs for boys
- Puberty Tanner stage \>1
- Weight \<12 Kg at screening
- Any prior treatment with GH
- Closed epiphysis
- Any diagnosed or suspected syndrome (e.g. Silver -Russell, Turner's or seckel syndrome) which possibly could affect growth
- Any other diagnosed or suspected endocrine or metabolic disorder
- Any diagnosed or suspected sever chronic disease
- Clinical signs of dysmorphic features, malformations or mental retardations
- Growth failure due to other disorders
- Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)
- Diagnosed malignant disease
- Any abnormal CS lab results that requires further investigation
- Receipt of an investigational drug within the last 28 days preceding screening or longer if considered possible to influence the outcome of the current trial
- Any knowledge of hypersensitivity to somatropin or any of the excipients of Zomacton or Genotropin
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00884000
Start Date
January 1 2010
End Date
July 1 2012
Last Update
July 17 2012
Active Locations (43)
Enter a location and click search to find clinical trials sorted by distance.
1
Semmelweiss University, 1st dept of paediatrics
Budapest, Hungary
2
Szent Janos Kh Budai
Budapest, Hungary
3
Petz Country Teaching Hospital
Győr, Hungary
4
University of Szeged
Szeged, Hungary