Status:
COMPLETED
An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Turner's Syndrome
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
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 needl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00250250
Start Date
October 1 2005
End Date
August 1 2006
Last Update
May 20 2011
Active Locations (6)
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1
Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,
Olomouc, Czechia, 775 20
2
Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159
Prague, Czechia, 100 81
3
Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a
Ústí nad Labem, Czechia, 401 13
4
Centre d'Endocrinologie Pediatrique, 25 rue Boudet
Bordeaux, France, 33000