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Surveillance of Treatment of Children With Growth Hormone Deficiency With Zomacton®

This study has been withdrawn prior to enrollment.
(Change of local requirements)
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01731028
First received: November 16, 2012
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to investigate the long-term treatment with Zomacton® for pituitary short stature in children with insufficient growth hormone production and/or short stature caused by Turner's syndrome.


Condition Intervention
Growth Hormone Deficiency
 Drug: Somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice

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® treatment measured by the increase in body height per annuum [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of Zomacton® treatment measured by the increase in body weight per annuum [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Safety of Zomacton® and the application device measured by local adverse reactions to the application device [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Somatropin
Children with growth hormone deficiency treated with somatropin as Zomacton® according to the marketing authorization
 Drug: Somatropin
Somatropin powder and solvent for solution for injection

  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children with inadequate secretion of growth-hormone; growth retardation due to Turner's syndrome

Criteria

Inclusion Criteria:

  • therapeutic need according to the approved specific products characteristics (SPC)

Exclusion Criteria:

  • contraindication according to the SPC
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731028

Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01731028     History of Changes
Other Study ID Numbers: 000091
Study First Received: November 16, 2012
Last Updated: January 31, 2013
Health Authority: Czech Republic: State Institute for Drug Control

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 21, 2013