Phase 4
N=42
Easypod United States User Trial
Growth Hormone Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT00689260 ↗Enrolled (actual)
42
Serious AEs
4.8%
Results posted
Jul 2010
Primary outcome: Primary: Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log) — 20; 19.46; 20 Percent of injections missed — p=0.908
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- easypod (Device)
- Age
- Pediatric, Adult · 10+ yrs
- Sex
- All
- Sponsor
- EMD Serono
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log) |
20; 19.46; 20 | 0.908 |
| SECONDARY Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices |
5; 5; 10; 1; 3; 4 | — |
| SECONDARY Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices. |
3; 7; 10; 3; 5; 8 | — |
| SECONDARY Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices. |
2; 6; 8; 2; 2; 4 | — |
Summary
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00689260). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.