Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00250250
Status:
COMPLETED
Last Update Posted:
2011-05-20
First Post:
2005-11-07
Brief Title:
An Open-Label Multi-centre Phase III Study of Local Tolerability of ZOMACTON 10MG
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
An Open-Label Multi-centre Phase III Study of Local Tolerability of ZOMACTON 10MG Recombinant Somatropin Administered by ZomaJet Vision X
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Children with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turners syndrome are individually dosed and treated for 12 weeks
Detailed Description:
Ferring Pharmaceuticals AS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None