Easypod United States User Trial

Growth Hormone Deficiency Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00689260
• Other study ID #: 28358
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2008
• Last updated: April 27, 2015
• Start date: March 2008
• Est. completion date: October 2009

Study information

• Verified date: April 2015
• Source: EMD Serono
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: October 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Dwarfism, Pituitary
• Growth Hormone Deficiency

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	US Medical Information	Rockland	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
EMD Serono

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)		90 Days	No
Secondary	Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices		90 Days	No
Secondary	Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.		90 Days	No
Secondary	Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.		90 Days	No