Status:
COMPLETED
Easypod United States User Trial
Lead Sponsor:
EMD Serono
Conditions:
Growth Hormone Deficiency
Eligibility:
All Genders
10-18 years
Phase:
PHASE4
Brief Summary
This study will help to determine whether an injection log on a recombinant human growth hormone (rhGH) delivery device improves subjects' adherence with injection schedules. Adherence will be compare...
Eligibility Criteria
Inclusion
- Be male or female from 10 to 18 years of age, inclusive, with open epiphyses
- Have GH deficiency diagnosed by treating pediatric endocrinologist for at least 6 months
- Be undergoing rhGH treatment via self-injection using the Lilly Humatrope® or Pfizer Genotropin® pen injection device for at least 6 months
- Be willing and able to comply with the protocol for the duration of the trial
- Have access to the Internet
- Be able to read, speak and understand English
- If female of childbearing potential, have a negative urine pregnancy test at Screening and use an acceptable form of birth control during the trial, including abstinence, a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide
Exclusion
- Known allergy or hypersensitivity to rhGH or prescribed diluent (0.3% metacresol for click.easy® cartridge)
- Severe illness during the previous 6 months
- Active malignancy (except non-melanomatous skin malignancies)
- Diabetes mellitus (type I or II)
- Pregnancy or lactation
- Any medical condition that, in the opinion of the Investigator, would jeopardize the subject's safety following exposure to the investigational device
- Participation in any other investigational study during the duration of participation in this trial
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00689260
Start Date
March 1 2008
End Date
October 1 2009
Last Update
May 15 2015
Active Locations (1)
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1
US Medical Information
Rockland, Massachusetts, United States, 02370