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Easypod United States User Trial
This study is currently recruiting participants.
Verified by EMD Serono, January 2009
Sponsored by: EMD Serono
Information provided by: EMD Serono
ClinicalTrials.gov Identifier: NCT00689260
  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
Growth Hormone Deficiency

Genetics Home Reference related topics: pseudoachondroplasia
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
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

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • The primary efficacy variable is the percent of rhGH injections missed during 90 days (or during trial participation) based on the easypod™ injection log. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subject perceptions of the ease/convenience of use of the easypod™ and preference for the easypod™ compared to two other rhGH pen injection devices. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Serum


Estimated Enrollment: 100
Study Start Date: March 2008
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Dose Log Aware and Daily Diary Enabled
2
Dose Log Aware and Daily Diary Disabled
3
Dose Log Unaware and Daily Diary Enabled
4
Dose Log Unaware and Daily Diary Disabled

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Primary care clinic

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

Contacts
Contact: John Gourley 781-681-2857 john.gourley@emdserono.com

Locations
United States, Massachusetts
US Medical Information Recruiting
Rockland, Massachusetts, United States, 02370
Contact: US Med Info Office     888-275-7376        
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Ahmad AL-Sabbagh, MD EMD Serono, Inc
  More Information

Responsible Party: EMD Serono, Inc. ( Ahmad AL-Sabbagh, MD, Senior VP, Head of US Medical Affairs )
Study ID Numbers: 28358
Study First Received: May 22, 2008
Last Updated: January 6, 2009
ClinicalTrials.gov Identifier: NCT00689260  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Dwarfism
Bone Diseases, Endocrine
Hypopituitary dwarfism
Hypothalamic Diseases
Pituitary Diseases
Central Nervous System Diseases
Endocrine System Diseases
Dwarfism, Pituitary
Brain Diseases
Bone Diseases
Growth hormone deficiency
Musculoskeletal Diseases
Hypopituitarism
Bone Diseases, Developmental
Endocrinopathy

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009