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

Turner's Syndrome Clinical Trial

Official title:

An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG (Recombinant Somatropin) Administered by ZomaJet Vision X

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250250
• Other study ID #: FE999905 CS002
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2005
• Last updated: May 19, 2011
• Start date: October 2005
• Est. completion date: August 2006

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: August 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 3 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Primary Ovarian Insufficiency
• Turner Syndrome
• Turner's Syndrome

Intervention

Drug:
• ZOMACTON

Locations

Country	Name	City	State
Czech Republic	Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,	Olomouc
Czech Republic	Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159	Prague 10
Czech Republic	Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a	Usti nad Labem
France	Centre d'Endocrinologie Pediatrique, 25 rue Boudet	Bordeaux
France	Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert	Le Havre cedex
Netherlands	Vu medisch centrum, Paediatrics, De Boelelaan 1117, PO Box 7057	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

Czech Republic,  France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X			No