Evaluating Acceptance of New Liquid Somatropin Formulation in Children With Growth Hormone Deficiency

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

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-23

Study Completion Date

2002-10-10

Brief Summary

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This trial is conducted in Asia. The aim of this trial is to evaluate the new liquid somatropin formulation in children with growth hormone deficiency.

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Detailed Description

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Conditions

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Growth Hormone Disorder Growth Hormone Deficiency in Children Genetic Disorder Turner Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Somatropin

Group Type EXPERIMENTAL

somatropin

Intervention Type DRUG

Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin)

Interventions

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somatropin

Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written Informed Consent by patient and/or guardian/parents
* Patients with one of the following diagnosis: Growth failure due to growth hormone deficiency (GHD), Turner syndrome, or growth retardation in children with chronic renal disorders
* Patients who are willing to inject themselves and answer questionnaires or young patients whose parents/guardian are willing to inject their child and answer questionnaires
* Patients on growth hormone therapy for at least 6 weeks before entering the trial

Exclusion Criteria

* Pregnancy or breast feeding women
* Suspected or known allergy to trial product
* Other daily injection therapy (non-growth hormone, e.g insulin-therapy)
* Participating in any other trial involving other investigational products within the last 3 months

Eligible Sex

ALL

Accepts Healthy Volunteers

No