Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
42 participants
INTERVENTIONAL
2008-03-31
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SINGLE
Study Groups
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1 - Log Aware
Dose Log Aware (patient is aware that the device records their injection information) Half the subjects in the log aware arm will complete a diary. The other half in the log aware arm will not complete the diary.
easypod
Subjects is aware that the device records injection information that can be viewed by user
2 - Log Unaware
Dose Log Unaware (patient is not aware that the device records their injection information) Half the subjects in the log unaware arm will complete a diary. The other half in the log unaware arm will not complete the diary.
easypod
Subjects is not aware that the device records injection information that can be viewed by user
Interventions
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easypod
Subjects is aware that the device records injection information that can be viewed by user
easypod
Subjects is not aware that the device records injection information that can be viewed by user
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
10 Years
18 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible, MD
Role: STUDY_DIRECTOR
EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
Locations
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US Medical Information
Rockland, Massachusetts, United States
Countries
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Other Identifiers
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28358
Identifier Type: -
Identifier Source: org_study_id
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