Back to resultsAn Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG
Primary Purpose
Turner's Syndrome
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ZOMACTON
Sponsored by
About this trial
This is an interventional treatment trial for Turner's Syndrome
Eligibility 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
Sites / Locations
- Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,
- Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159
- Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a
- Centre d'Endocrinologie Pediatrique, 25 rue Boudet
- Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert
- Vu medisch centrum, Paediatrics, De Boelelaan 1117, PO Box 7057
Outcomes
Primary Outcome Measures
To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00250250
Brief Title
An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG
Official Title
An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG (Recombinant Somatropin) Administered by ZomaJet Vision X
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ferring Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Turner's Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ZOMACTON
Primary Outcome Measure Information:
Title
To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,
City
Olomouc
ZIP/Postal Code
775 20
Country
Czech Republic
Facility Name
Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159
City
Prague 10
ZIP/Postal Code
100 81
Country
Czech Republic
Facility Name
Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a
City
Usti nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
Facility Name
Centre d'Endocrinologie Pediatrique, 25 rue Boudet
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Service de Pédiatrie, Groupe Hospitalier du Havre, 55 bis, rue Gustave Flaubert
City
Le Havre cedex
ZIP/Postal Code
76083
Country
France
Facility Name
Vu medisch centrum, Paediatrics, De Boelelaan 1117, PO Box 7057
City
Amsterdam
ZIP/Postal Code
10007 MB
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG
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