Trials / Completed
CompletedNCT00450190
Saizen® E-Device User Trial
User Trial on the Use in Common Practice of a New Electronic Auto-injector of Saizen®, the E-Device (Electronic Device), in Children Treated by Recombinant Human Growth Hormone Over a Period of 2 Months
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2006-02-28
- Primary completion
- 2006-09-30
- Completion
- 2006-09-30
- First posted
- 2007-03-22
- Last updated
- 2018-07-23
- Results posted
- 2018-07-23
Source: ClinicalTrials.gov record NCT00450190. Inclusion in this directory is not an endorsement.