Phase 3
Completed N=120
Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
Source: ClinicalTrials.gov NCT01112865 ↗Enrolled (actual)
120
Serious AEs
1.7%
Results posted
May 2012
Primary outcomePrimary: Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® — 67.23 percentage of dyads, adult participants
Summary
Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Dyads (Participant and Caregiver or Parent) and Adult Participants Reporting no Difference or Easier to Use for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® |
67.23 | — |
| SECONDARY Percentage of Dyads and Adult Participants Reporting no Preference or Preference for the New Genotropin Mark VII Injection Pen Compared to the Genotropin Pen® |
64.17 | — |
| SECONDARY Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Easier to Use Compared to the Genotropin Pen® |
51.26 | — |
| SECONDARY Percentage of Dyads and Adult Participants Reporting the New Genotropin Mark VII Injection Pen Preferable Compared to the Genotropin Pen® |
54.17 | — |
| SECONDARY Percentage of Dyads and Adult Participants Who Would Choose the New Genotropin Mark VII Injection Pen in Preference to the Genotropin® Pen |
47.27 | 0.6858 |
| SECONDARY Ease of Use of Each Injection Pen |
4.5; 4.2 | — |
Eligibility Criteria
Inclusion Criteria
- Age greater than or equal to 8 years.
- Subjects who are starting treatment with growth hormone (Genotropin) for the first time.
Exclusion Criteria
- Subjects with Prader-Willi syndrome or chronic renal insufficiency.
- Subjects and caregivers who, in the opinion of the investigator are not able to adequately participate in the study.
- Subjects with chronic systemic disorders, such as diabetes and heart disease.
Data sourced from ClinicalTrials.gov (NCT01112865). 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. Informational only — not medical advice.