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Completed

NCT Number: NCT00884000

A Study of Zomacton in Children With Growth Hormone Deficiency

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.

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Key information

Conditions

Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Semmelweiss University, 1st dept of paediatrics, Budapest, Hungary

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Genotropin

Drug

Zomacton

Drug

Primary outcomes

  1. Height Velocity

    Time frame: 12 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2009
Registry last updated
Jul 17, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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