At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 20 enrolled

Drug / intervention

Saizen® E-Devicedevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00450190

NCT00450190Phase 3Completed

Compare CT.gov

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

Merck KGaA, Darmstadt, Germany·interventional·Posted Mar 22, 2007·Updated Jul 23, 2018

In Brief

A Phase 3 clinical trial evaluating Saizen® E-Device for Growth Disorders. Completed, enrolled 20 participants.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGrowth Disorders

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2006

Primary CompletionSep 2006

First PostedMar 2007

TodayJul 2026

First PostedMar 22, 2007

Enrollment StartFeb 28, 2006

Primary CompletionSep 30, 2006

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 19.3 years ago

Interventions

Saizen® E-Devicedevice

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.