A Study of Zomacton in Children With Growth Hormone Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00884000
First received: April 17, 2009
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Growth Hormone Deficiency
Drug: Genotropin
Drug: Zomacton
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised, Open-label, Parallel-group, Multi-centre Trial to Compare the Efficacy and Safety for 12 Months of Zomacton to Genotropin in Children With Idiopathic Growth Hormone Deficiency

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Height Velocity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Height SDS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Height velocity SDS [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in IGF-1 and IGFBP-3 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • BA (Bone Age) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Anti-hGH AB [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • AE and tolerability [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • CS Changes in safety lab, physical examination and vital signs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 165
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Genotropin
Experimental: 2 Drug: Zomacton

  Eligibility

Ages Eligible for Study:   3 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent
  2. Children aged ≤3yrs old and not above 10 yrs for girls or 11 yrs for boys
  3. 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)
  4. Height SDS <-2 SD of ref value for CA
  5. Height velocity SDSCA ≤ 0 SD of ref value for at lease 6 months prior to pre-screening
  6. Height recorded for at least 6 months but not more than 18 months of pre-screening
  7. The difference between CA-BA≥ 1
  8. 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 Criteria:

  1. BA above 9 yrs for girls and 10 yrs for boys
  2. Puberty Tanner stage >1
  3. Weight <12 Kg at screening
  4. Any prior treatment with GH
  5. Closed epiphysis
  6. Any diagnosed or suspected syndrome (e.g. Silver -Russell, Turner's or seckel syndrome) which possibly could affect growth
  7. Any other diagnosed or suspected endocrine or metabolic disorder
  8. Any diagnosed or suspected sever chronic disease
  9. Clinical signs of dysmorphic features, malformations or mental retardations
  10. Growth failure due to other disorders
  11. Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)
  12. Diagnosed malignant disease
  13. Any abnormal CS lab results that requires further investigation
  14. 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
  15. Any knowledge of hypersensitivity to somatropin or any of the excipients of Zomacton or Genotropin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884000

  Show 43 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00884000     History of Changes
Other Study ID Numbers: FE999905 CS07, 2008-004849-28
Study First Received: April 17, 2009
Last Updated: July 16, 2012
Health Authority: Israel: Ministry of Health
Israel: Ethics Commission
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Romania: National Medicines Agency
Romania: National Authority for Scientific Research
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health
Hungary: National Institute of Pharmacy
Germany: German Institute of Medical Documentation and Information
Germany: Ethics Commission
Russia: Ethics Committee
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
India: Drugs Controller General of India
India: Institutional Review Board

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Dwarfism
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on September 18, 2014