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Easypod United States User Trial

This study has been completed.
Sponsor:
Information provided by:
EMD Serono
ClinicalTrials.gov Identifier:
NCT00689260
First received: May 22, 2008
Last updated: August 2, 2013
Last verified: October 2010
  Purpose

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.


Condition Intervention Phase
Growth Hormone Deficiency
Device: easypod
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log) [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
  • Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
  • Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: March 2008
Study Completion Date: October 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 not aware that the device records injection information that can be viewed by user

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00689260

Locations
United States, Massachusetts
US Medical Information
Rockland, Massachusetts, United States, 02370
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Sanja Dragnic, MD EMD Serono, Inc.
  More Information

No publications provided

Responsible Party: Sanja Dragnic, Medical Director, Endocrinology, EMD Serono, Inc.
ClinicalTrials.gov Identifier: NCT00689260     History of Changes
Other Study ID Numbers: 28358
Study First Received: May 22, 2008
Results First Received: June 17, 2010
Last Updated: August 2, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dwarfism, Pituitary
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Endocrine System Diseases
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases

ClinicalTrials.gov processed this record on November 27, 2014