Status:
COMPLETED
Saizen® E-Device User Trial
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Conditions:
Growth Disorders
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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 interfac...
Eligibility Criteria
Inclusion
- 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)
- 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
- Known hypersensitivity to somatropin or any of the excipients
- Epiphyseal fusion
- Active neoplasia (either newly diagnosed or recurrent)
- History of intracranial hypertension with papilledema
- Diabetes mellitus or history of significant glucose intolerance as defined by a fasting blood glucose \> 116 mg/dL
- Severe congenital malformations
- Severe psychomotor retardation
- Known hepatic disease as defined by elevated liver enzymes or total bilirubin (x 2 N)
- Current congestive heart failure, untreated hypertension, serious chronic oedema of any cause
- Chronic infectious disease
- Previous or ongoing treatment with sex steroid therapy such as estrogens and testosterone
- Previous or ongoing treatment with any therapy that may directly influence growth, including GH, GHRF and long duration corticosteroids therapy
- Proliferative or preproliferative diabetic retinopathy
- Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
- Precocious puberty
- Severe associated pathology affecting growth such as malnutrition, malabsorption or bone dysplasia
- Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment
- Participation to any clinical study within the 30 days preceding study entry
- Pregnancy
Key Trial Info
Start Date :
February 28 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00450190
Start Date
February 28 2006
End Date
September 30 2006
Last Update
July 23 2018
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