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A Study of Zomacton in Children With Growth Hormone Deficiency

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00884000
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 17, 2009
First Posted Date  ICMJE April 20, 2009
Last Update Posted Date July 17, 2012
Study Start Date  ICMJE January 2010
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2009)
Height Velocity [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2009)
  • Height SDS [ Time Frame: 12 months ]
  • Height velocity SDS [ Time Frame: 12 months ]
  • Change in IGF-1 and IGFBP-3 [ Time Frame: 12 months ]
  • BA (Bone Age) [ Time Frame: 12 months ]
  • Anti-hGH AB [ Time Frame: 12 months ]
  • AE and tolerability [ Time Frame: 12 months ]
  • CS Changes in safety lab, physical examination and vital signs [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Zomacton in Children With Growth Hormone Deficiency
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Growth Hormone Deficiency
Intervention  ICMJE
  • Drug: Genotropin
  • Drug: Zomacton
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: Genotropin
  • Experimental: 2
    Intervention: Drug: Zomacton
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2012)
165
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2009)
138
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   India,   Israel,   Poland,   Romania,   Russian Federation,   Ukraine
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00884000
Other Study ID Numbers  ICMJE FE999905 CS07
2008-004849-28
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Development Support Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP