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

January 31, 2013 updated by: Ferring Pharmaceuticals

Non-interventional, Observational Study of the Application of Zomacton® in the Treatment of Growth Hormone Deficiency in Routine Clinical Practice

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • contraindication according to the SPC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Efficacy of Zomacton® treatment measured by the increase in body height per annuum
Time Frame: 5 years
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

November 16, 2012

First Submitted That Met QC Criteria

November 16, 2012

First Posted (Estimate)

November 21, 2012

Study Record Updates

Last Update Posted (Estimate)

February 1, 2013

Last Update Submitted That Met QC Criteria

January 31, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 000091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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