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Online Surveillance of Treatment of Children With Growth Hormone Deficiency With ZOMACTON

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01365351
First Posted: June 3, 2011
Last Update Posted: June 2, 2017
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.
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
  Purpose
The purpose of this study is to investigate long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner syndrome.

Condition Intervention
Growth Hormone Deficiency Other: Growth hormone

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-interventional Study With ZOMACTON in Children With Growth Hormone Deficiency

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Efficacy of ZOMACTON [ Time Frame: Up to 5 years ]
    measured by: body height, increase of body height per annum


Secondary Outcome Measures:
  • Efficacy measured by further parameters [ Time Frame: Up to 5 years ]
    measured by: weight, increase weight per annum sitting height, increase of sitting height per annum head circumference per annum bone age, increase of bone age per annum puberty development IGF-1, IGFBP-3 psychological cofactors

  • Safety of Zomacton and application device [ Time Frame: Up to 5 years ]
    measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory


Enrollment: 1034
Actual Study Start Date: December 1, 2007
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Growth hormone
Children with growth hormone deficiency
Other: Growth hormone
Drug given by prescription

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinics and private practices
Criteria

Inclusion Criteria:

  • therapeutic need according to SPC
  • written informed consent

Exclusion Criteria:

  • contraindications according to SPC
  Contacts and Locations
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): NCT01365351


  Show 59 Study Locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Ferring Arzneimittel GmbH
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01365351     History of Changes
Other Study ID Numbers: ZOM/011207/03
First Submitted: June 1, 2011
First Posted: June 3, 2011
Last Update Posted: June 2, 2017
Last Verified: June 2017

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
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs