NCT00250250

An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG

An Open-Label, Multi-centre, Phase III Study of Local Tolerability of ZOMACTON 10MG (Recombinant Somatropin) Administered by ZomaJet Vision X

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

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.

Conditions

• Turner's Syndrome

Interventions

Type	Name	Description
DRUG	ZOMACTON

Timeline

• Start date: 2005-10-01
• Primary completion: 2006-03-01
• Completion: 2006-08-01
• First posted: 2005-11-08
• Last updated: 2011-05-20

Locations

6 sites across 3 countries: Czechia, France, Netherlands