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A Study of Zomacton in Children With Growth Hormone Deficiency

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ClinicalTrials.gov Identifier: NCT00884000
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : July 17, 2012
Information provided by (Responsible Party):
Ferring Pharmaceuticals

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 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 or disease Intervention/treatment Phase
Growth Hormone Deficiency Drug: Genotropin Drug: Zomacton Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : July 2012

Arm Intervention/treatment
Active Comparator: 1 Drug: Genotropin
Experimental: 2 Drug: Zomacton

Primary Outcome Measures :
  1. Height Velocity [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Height SDS [ Time Frame: 12 months ]
  2. Height velocity SDS [ Time Frame: 12 months ]
  3. Change in IGF-1 and IGFBP-3 [ Time Frame: 12 months ]
  4. BA (Bone Age) [ Time Frame: 12 months ]
  5. Anti-hGH AB [ Time Frame: 12 months ]
  6. AE and tolerability [ Time Frame: 12 months ]
  7. CS Changes in safety lab, physical examination and vital signs [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00884000

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Sponsors and Collaborators
Ferring Pharmaceuticals
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Study Director: Clinical Development Support Ferring Pharmaceuticals
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Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00884000    
Other Study ID Numbers: FE999905 CS07
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012
Additional relevant MeSH terms:
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Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases