Saizen® E-Device User Trial

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-09-30

Brief Summary

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The aim of the study is to evaluate the E-Device performances and handling on the use in common practice, by collecting the impressions of patients, nurses and the investigator on the graphic interface, the instructions manual, the E-Device training and the material itself.

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Detailed Description

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Conditions

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Growth Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Saizen® E-Device

Group Type EXPERIMENTAL

Saizen® E-Device

Intervention Type DEVICE

Saizen® (recombinant human growth hormone \[r-hGH\]) injection 8 milligram (mg) per 137 milliliter (mL) will be administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days.

Interventions

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Saizen® E-Device

Saizen® (recombinant human growth hormone \[r-hGH\]) injection 8 milligram (mg) per 137 milliliter (mL) will be administered using an electronic auto-injector (E-Device) subcutaneously (SC) in the evening as per local Summary of Product Characteristics (SmPC) for 60 days.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients naïve to, or experienced with, Saizen® with growth disorders in registered indications (GHD, Turner's Syndrome, Chronic Renal Failure, patient born Small Gestational Age \[SGA\] according to the local SmPC)
2. Written informed consent must be obtained from the parent(s)/legal guardian(s) at the beginning of the study. Children able to understand the trial should personally sign and date the written informed consent

Exclusion Criteria

1. Known hypersensitivity to somatropin or any of the excipients
2. Epiphyseal fusion
3. Active neoplasia (either newly diagnosed or recurrent)
4. History of intracranial hypertension with papilledema
5. Diabetes mellitus or history of significant glucose intolerance as defined by a fasting blood glucose \> 116 mg/dL
6. Severe congenital malformations
7. Severe psychomotor retardation
8. Known hepatic disease as defined by elevated liver enzymes or total bilirubin (x 2 N)
9. Current congestive heart failure, untreated hypertension, serious chronic oedema of any cause
10. Chronic infectious disease
11. Previous or ongoing treatment with sex steroid therapy such as estrogens and testosterone
12. Previous or ongoing treatment with any therapy that may directly influence growth, including GH, GHRF and long duration corticosteroids therapy
13. Proliferative or preproliferative diabetic retinopathy
14. Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
15. Precocious puberty
16. Severe associated pathology affecting growth such as malnutrition, malabsorption or bone dysplasia
17. Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment
18. Participation to any clinical study within the 30 days preceding study entry
19. Pregnancy

Eligible Sex

ALL

Accepts Healthy Volunteers

No