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

Ferring Pharmaceuticals27 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Turner's Syndrome

Interventions

ZOMACTONDRUG

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (6)

Faculty Hospital Olomouc, Children's Clinic, Endocrinology Outpatient Department, I.P.Pavlova str. 6,

Olomouc, Czechia

Faculty Hospital Kralovske Vinohrady, Children's Clinic, Vinohradska str. 159

Prague, Czechia

Masaryk Hospital Usti nad Labem, Children's Clinic, Building D2, Endocrinology Outpatient Department, Socialni pece 12a

Ústí nad Labem, Czechia

Outcomes

Primary Outcomes

To assess the local tolerability of an individualised dose of ZOMACTON 10 mg administered by ZomaJet Vision X

Data from ClinicalTrials.gov

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