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| Sponsor: | Ferring Pharmaceuticals |
|---|---|
| Information provided by: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00250250 |
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 III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment |
| Official Title: | An Open-Label, Multi-Centre, Phase III Study of Local Tolerability of ZOMACTON 10MG (Recombinant Somatropin) Administered by ZomaJet Vision X |
| 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) |
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 |
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| Czech Republic | |
| 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 | |
| Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6, | |
| Olomouc, Czech Republic, 775 20 | |
| 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 | |
| Study Director: | Clinical Development Support | Ferring Pharmaceuticals |
More Information
| Responsible Party: | Ferring Pharmaceuticals ( Hjort, Director ) |
| Study ID Numbers: | FE999905 CS002 |
| Study First Received: | November 7, 2005 |
| Last Updated: | February 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00250250 History of Changes |
| Health Authority: | Czech Republic: State Institute for Drug Control |
|
Disease Gonadal Disorders Chromosome Disorders Endocrine System Diseases Sex Differentiation Disorders Turner Syndrome Pathologic Processes |
Urogenital Abnormalities Genetic Diseases, Inborn Syndrome Sex Chromosome Disorders Congenital Abnormalities Gonadal Dysgenesis |
