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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This study has been withdrawn prior to enrollment.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)
Information provided by (Responsible Party):
Ferring Pharmaceuticals Identifier:
First received: November 16, 2012
Last updated: January 31, 2013
Last verified: January 2013
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:

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 ]

Secondary Outcome Measures:
  • Efficacy of Zomacton® treatment measured by the increase in body weight per annuum [ Time Frame: 5 years ]
  • Safety of Zomacton® and the application device measured by local adverse reactions to the application device [ Time Frame: 5 years ]

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
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


Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindication according to the SPC
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01731028

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

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01731028     History of Changes
Other Study ID Numbers: 000091
Study First Received: November 16, 2012
Last Updated: January 31, 2013

Additional relevant MeSH terms:
Endocrine System Diseases
Dwarfism, Pituitary
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 21, 2017