A Phase 4 interventional study of easypod and easypod in Growth Hormone Deficiency, sponsored by EMD Serono. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2015-05-15.
Sponsored by EMD Serono · Phase 4 and Interventional
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.
EMD Serono is the lead sponsor of 88 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
Subjects is not aware that the device records injection information that can be viewed by user
Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log)
Time frame: 90 Days
Subjects Perception of Easypod Ease of Use Compared to Two Other rhGH Pen Injection Devices
Time frame: 90 Days
Subject Perceptions of Easypod: Storage Convenience Compared to Two Other rhGH Pen Injection Devices.
Time frame: 90 Days
Subject Perceptions of Easypod: Preference to Use Easypod Over Two Other rhGH Pen Injection Devices.
Time frame: 90 Days
43 Subjects were randomized from 14 Clinics in the US from March 2008 through January 2009. One subject withdrew consent prior to first dose. Recruitment was ended early due to slow enrollment.
| Milestone | Log Aware | Log Unaware |
|---|---|---|
| Started | 21 | 21 |
| Completed | 19 | 21 |
| Not completed | 2 | 0 |
| Percent of injections missed | Log Aware | Log Unaware | Total |
|---|---|---|---|
| Percent rhGH Injections Missed During the Treatment Period (Based on the Easypod™ Injection Log) | 20 (0 to 71.7) | 19.46 (1.1 to 90.9) | 20 (0 to 90.9) |
| Participants | Humatrope | Genotropin | Total |
|---|---|---|---|
| Strongly Agree | 5 | 5 | 10 |
| Agree | 1 | 3 | 4 |
| Neutral | 0 | 4 | 4 |
| Disagree | 3 | 1 | 4 |
| Strongly Disagree | 2 | 3 | 5 |
| Missing | 5 | 3 | 8 |
| Participants | Humatrope | Genotropin | Total |
|---|---|---|---|
| Very Convenient | 3 | 7 | 10 |
| Convenient | 3 | 5 | 8 |
| Neutral | 5 | 3 | 8 |
| Not Very Convenient | 0 | 0 | 0 |
| Not at all Convenient | 0 | 1 | 1 |
| Missing | 5 | 3 | 8 |
| Participants | Humatrope | Genotropin | Total |
|---|---|---|---|
| Strongly Agree | 2 | 6 | 8 |
| Agree | 2 | 2 | 4 |
| Neutral | 2 | 1 | 3 |
| Disagree | 2 | 3 | 5 |
| Strongly Disagree | 3 | 4 | 7 |
| Missing | 5 | 3 | 8 |
Collected over Day 1, Week 12 and Four Week Follow-up. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Log Aware | — | 1/21 (4.8%) | 2/21 (9.5%) |
| Log Unaware | — | 1/21 (4.8%) | 5/21 (23.8%) |
| Event | Log Aware | Log Unaware |
|---|---|---|
| Brainstem TumorNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/21 | 0/21 |
| Syncopal episodesNervous system disorders | 0/21 | 1/21 |
| Event | Log Aware | Log Unaware |
|---|---|---|
| ConstipationGastrointestinal disorders | 0/21 | 1/21 |
| Injection site haematomaGeneral disorders | 1/21 | 0/21 |
| Injection site haemorrhageGeneral disorders | 0/21 | 1/21 |
| Gastroenteritis viralInfections and infestations | 0/21 | 1/21 |
| NasopharyngitisInfections and infestations | 1/21 | 0/21 |
| Back InjuryInjury, poisoning and procedural complications | 0/21 | 1/21 |
| HeadacheNervous system disorders | 1/21 | 0/21 |
| LaryngospasmRespiratory, thoracic and mediastinal disorders | 0/21 | 1/21 |
| Age, Categorical(Participants) | Log Aware | Log Unaware | Total |
|---|---|---|---|
| <=18 years | 21 | 21 | 42 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Log Aware | Log Unaware | Total |
|---|---|---|---|
| Mean | 12.4 ± 1.50 | 13.0 ± 2.56 | 12.7 ± 2.10 |
| Sex: Female, Male(Participants) | Log Aware | Log Unaware | Total |
|---|---|---|---|
| Female | 2 | 3 | 5 |
| Male | 19 | 18 | 37 |
| Region of Enrollment(participants) | Log Aware | Log Unaware | Total |
|---|---|---|---|
| United States | 21 | 21 | 42 |
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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EMD Serono