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Sponsored by: |
EMD Serono |
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Information provided by: | EMD Serono |
ClinicalTrials.gov Identifier: | NCT00689260 |
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 |
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Growth Hormone Deficiency |
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 |
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 |
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1
Dose Log Aware and Daily Diary Enabled
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2
Dose Log Aware and Daily Diary Disabled
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3
Dose Log Unaware and Daily Diary Enabled
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4
Dose Log Unaware and Daily Diary Disabled
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Ages Eligible for Study: | 10 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Primary care clinic
Inclusion Criteria:
Exclusion Criteria:
Contact: John Gourley | 781-681-2857 | john.gourley@emdserono.com |
United States, Massachusetts | |
US Medical Information | Recruiting |
Rockland, Massachusetts, United States, 02370 | |
Contact: US Med Info Office 888-275-7376 |
Study Director: | Ahmad AL-Sabbagh, MD | EMD Serono, Inc |
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 |
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 |
Nervous System Diseases |