Saizen® E-Device User Trial

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 3

Conditions: Growth Disorders

Treatments: Device: Saizen® E-Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00450190

26443

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Saizen® E-Device

Experimental group

Treatment:

Device: Saizen® E-Device