Easypod United States User Trial

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Growth Hormone Deficiency

Treatments: Device: easypod

Study type: Interventional

Funder types: Industry

Identifiers

NCT00689260

28358

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

42 participants in 2 patient groups

1 - Log Aware

Active Comparator group

Description:

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.

Treatment:

Device: easypod

Device: easypod

2 - Log Unaware

Active Comparator group

Description:

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.

Treatment:

Device: easypod

Device: easypod