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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Ferring Arzneimittel GmbH
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01365351
First received: June 1, 2011
Last updated: April 23, 2013
Last verified: April 2013
History of Changes
  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:

MedlinePlus related topics: Dwarfism
Drug Information available for: Somatropin
U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Efficacy of ZOMACTON [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    measured by: body height, increase of body height per annum


Secondary Outcome Measures:
  • Efficacy measured by further parameters [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    measured by: local adverse reactions to the application device adverse events of Zomacton safety laboratory


Estimated Enrollment: 400
Study Start Date: November 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01365351

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

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01365351     History of Changes
Other Study ID Numbers: ZOM/011207/03
Study First Received: June 1, 2011
Last Updated: April 23, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
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
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013