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

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ClinicalTrials.gov Identifier: NCT01731028
Recruitment Status : Withdrawn (Change of local requirements)
First Posted : November 21, 2012
Last Update Posted : February 1, 2013
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
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 or disease Intervention/treatment
Growth Hormone Deficiency Drug: Somatropin

Study Type : Observational
Actual Enrollment : 0 participants
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
Study Start Date : January 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : June 2018


Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Efficacy of Zomacton® treatment measured by the increase in body height per annuum [ Time Frame: 5 years ]

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


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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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindication according to the SPC

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): NCT01731028


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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01731028     History of Changes
Other Study ID Numbers: 000091
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013

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