An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG

This study has been completed.
Sponsor:
Information provided by:
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00250250
First received: November 7, 2005
Last updated: May 19, 2011
Last verified: May 2011
  Purpose

Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome are individually dosed and treated for 12 weeks


Condition Intervention Phase
Turner's Syndrome
Drug: ZOMACTON
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG (Recombinant Somatropin) Administered by ZomaJet Vision X

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: October 2005
Study Completion Date: August 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Ferring Pharmaceuticals A/S has developed a new ZOMACTON 10 mg formulation. The formulation provides a higher concentration and thereby a smaller volume to be administered. ZomaJet Vision X is a needle-free injection system. It sends a thin jet of ZOMACTON through the skin and into the subcutaneous tissue without the use of a needle. The mode of administration is referred to as "transjection". By use of ZomaJet Vision X, both transjection and reconstitution of ZOMACTON 10 mg can be done without using a needle. The rationale of the study is to describe the local tolerability of the new ZOMACTON 10 mg administered by ZomaJet Vision X.

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Subjects between the ages of 3 and 17 years (both inclusive) with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner's syndrome. Subjects have for a minimum of 6 months prior to study enrolment been receiving growth hormone therapy

  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 ClinicalTrials.gov identifier: NCT00250250

Locations
Czech Republic
Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,
Olomouc, Czech Republic, 775 20
Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159
Prague 10, Czech Republic, 100 81
Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a
Usti nad Labem, Czech Republic, 401 13
France
Centre d'Endocrinologie Pediatrique, 25 rue Boudet
Bordeaux, France, 33000
Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert
Le Havre cedex, France, 76083
Netherlands
Vu medisch centrum, Paediatrics, De Boelelaan 1117, PO Box 7057
Amsterdam, Netherlands, 10007 MB
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Clinical Development Support, Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00250250     History of Changes
Other Study ID Numbers: FE999905 CS002
Study First Received: November 7, 2005
Last Updated: May 19, 2011
Health Authority: Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:
Turner Syndrome
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 23, 2014