Easypod United States User Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Growth Hormone Deficiency
• Intervention / Treatment: Device: easypod; Device: easypod

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Rockland, Massachusetts, United States, 02370
      • US Medical Information

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: easypod; Subjects is aware that the device records injection information that can be viewed by user; Device: easypod; Subjects is not aware that the device records injection information that can be viewed by user
Active Comparator: 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.	Device: easypod; Subjects is aware that the device records injection information that can be viewed by user; Device: easypod; Subjects is not aware that the device records injection information that can be viewed by user

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)	90 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices	90 Days
Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.	90 Days
Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.	90 Days

Collaborators and Investigators

• Sponsor: EMD Serono
• Investigators: Study Director: Medical Responsible, MD, EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany

Study record dates

Study Major Dates

• Study Start: March 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: May 22, 2008
• First Submitted That Met QC Criteria: June 2, 2008
• First Posted (Estimate): June 3, 2008

Study Record Updates

• Last Update Posted (Estimate): May 15, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 28358