Phase 3
N=20
Saizen® E-Device User Trial
Growth Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00450190 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcome: Primary: Subjects' Overall Impression After Using E-Device — 0; 7; 13 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Saizen® E-Device (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Sep 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjects' Overall Impression After Using E-Device |
0; 7; 13 | — |
| PRIMARY Usefulness and Reliability of E-Device Functions |
0; 8; 12; 3; 11; 6 | — |
| SECONDARY Subjects' Feedback Immediately After Initial Training During Inclusion Visit |
1; 17; 2; 2; 15; 3 | — |
| SECONDARY Nurse/Physician's Feedback After E-Device Set up During Inclusion Visit |
1; 19; 0; 0; 19; 0 | — |
| SECONDARY Number of Subjects With Adverse Events (AEs) or Serious Adverse Events (SAEs) |
0; 0 | — |
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 interface, the instructions manual, the E-Device training and the material itself.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00450190). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.