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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-08-31

Brief Summary

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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

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Detailed Description

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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

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Turner's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ZOMACTON

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes