Skip to main content
OpenTrials
Completed

NCT Number: NCT00689260

Easypod United States User Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

US Medical Information

Rockland, Massachusetts, 02370, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Easypod

Device

Subjects is aware that the device records injection information that can be viewed by user

Primary outcomes

  1. Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)

    Time frame: 90 Days

Secondary outcomes

  1. Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices

    Time frame: 90 Days

  2. Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.

    Time frame: 90 Days

  3. Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.

    Time frame: 90 Days

Sponsors and collaborators

Lead sponsor

EMD Serono

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 3, 2008
Registry last updated
May 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.