An Open-Label, Multi-Centre, Phase III Study of Local Tolerability of ZOMACTON 10MG
Information source: Ferring Pharmaceuticals
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Turner's Syndrome
Intervention: ZOMACTON (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Ferring Pharmaceuticals Official(s) and/or principal investigator(s):
Delemarre van de Waal, H.A., Principal Investigator, Affiliation: Paediatric Endocrinology, University Hospital
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
Clinical Details
Official title:
An Open-Label, Multi-Centre, Phase III Study of Local Tolerability of ZOMACTON 10MG (Recombinant Somatropin) Administered by ZomaJet Vision X
Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Single Group Assignment
Primary outcome: To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X
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.
Eligibility
Minimum age: 3 Years.
Maximum age: 17 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date:
September 2005
Ending date: March 2006
Last updated: November 7, 2005
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