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

Phase 3

Completed

• Conditions: Turner's Syndrome

• Registration Number: NCT00250250
• Lead Sponsor: Ferring Pharmaceuticals

Brief 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

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.

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-11-07
• Study First Submitted QC: 2005-11-07
• Study First Posted: 2005-11-08
• Primary Completion: 2006-03
• Study Completion: 2006-08
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-19
• Last Update Posted: 2011-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X

Trial Locations

Locations (6)

Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,; 🇨🇿 Olomouc, Czech Republic

Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert; 🇫🇷 Le Havre cedex, France

Centre d'Endocrinologie Pediatrique, 25 rue Boudet; 🇫🇷 Bordeaux, France

Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159; 🇨🇿 Prague 10, Czech Republic

Vu medisch centrum, Paediatrics, De Boelelaan 1117, PO Box 7057; 🇳🇱 Amsterdam, Netherlands

Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a; 🇨🇿 Usti nad Labem, Czech Republic