We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT01731028
Recruitment Status : Withdrawn (Change of local requirements)
First Posted : November 21, 2012
Last Update Posted : February 1, 2013
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

Layout table for study information
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
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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
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

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
Layout table for investigator information
Study Director: Clinical Development Support Ferring Pharmaceuticals
Layout table for additonal information
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01731028    
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:
Layout table for MeSH terms
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Bone Diseases, Endocrine
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases