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

Ferring

Status and phase

Completed

Phase 3

Conditions

Turner's Syndrome

Treatments

Drug: ZOMACTON

Study type

Interventional

Funder types

Industry

Identifiers

NCT00250250

FE999905 CS002

Details and patient eligibility

About

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

Full 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.

Enrollment

27 patients

Sex

All

Ages

3 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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