Clinical trial NCT00689260: Easypod United States User Trial
Official title: A Randomized, Multicenter, 3 Month Phase IV Study to Evaluate the Effect on Subject Adherence With Injection Schedule by Using the Easypod™ rhGH Delivery Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Growth Hormone Deficiency
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 42
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

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 compared between a group of subjects who are aware of the injection log on the easypod™ rhGH delivery device and a group of subjects who are not aware of the easypod™ injection log. It is the study hypothesis that subject non-adherence rate is different for those who are aware of the injection log capability versus those who are unaware of the injection log capability. Subject perception will also be evaluated by comparing the ease and convenience of use and subject preference for the easypod™ compared to two other rhGH pen injection devices.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)
timeFrame: 90 Days
Secondary outcomes:
measure: Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices
timeFrame: 90 Days
measure: Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.
timeFrame: 90 Days
measure: Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.
timeFrame: 90 Days
Other outcomes:
Locations:
city: Rockland
country: United States
facility: US Medical Information
state: Massachusetts
Study officials:
affiliation: EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible, MD
role: STUDY_DIRECTOR
References: