Clinical Trial: Saizen® E-Device User Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

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 interface, the instructions manual, the E-Device training and the material itself.

Detailed Summary:
Sponsor: Merck KGaA

Current Primary Outcome: To evaluate patients' feedback after 2 weeks of E-Device use with a questionnaire (by phone) on qualitative first global impression of the E-Device and on usefulness and reliability of each E-Device function [ Time Frame: 2 weeks ]

Original Primary Outcome: To evaluate patients' feedback after 2 weeks of E-Device use with a questionnaire (by phone) on qualitative first global impression of the E-Device and on usefulness and reliability of each E-Device function

Current Secondary Outcome: To evaluate patients' feedback on the use of E-Device by using a questionnaire: To evaluate the nurse/physician's feedback after the E-Device set up at the inclusion visit and To assess the safety during the treatment and follow-up period of the study [ Time Frame: Various time points ]

Original Secondary Outcome:

Information By: Merck KGaA

Dates:
Date Received: March 21, 2007
Date Started: February 2006
Date Completion:
Last Updated: February 17, 2014
Last Verified: February 2014