Phase 3
Completed N=136
Genotropin Study Assessing Use of Injection Pen
Source: ClinicalTrials.gov NCT00965484 ↗Enrolled (actual)
136
Serious AEs
0.0%
Results posted
Dec 2010
Primary outcomePrimary: Percentage of Dyads (Participant and Caregiver or Parent) Reporting no Difference or Easier to Use for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen® — 73.68 percentage of dyads
Summary
Assessment of Genotropin patient and caregiver (Dyad) perception of convenience and preference of Genotropin injection pen. Patients already on genotropin will be asked to use a genotropin pen for 2 months. Patient and caregiver will be asked to complete a questionnaire at baseline and 2 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Dyads (Participant and Caregiver or Parent) Reporting no Difference or Easier to Use for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen® |
73.68 | — |
| SECONDARY Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen® |
65.15 | — |
| SECONDARY Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen® |
63.16 | — |
| SECONDARY Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen® |
59.85 | — |
Eligibility Criteria
Inclusion Criteria
- Age 8-18 years
- Using genotropin pen for at least 3 months prior to study enrollment
- Compliance with genotropin treatment
Exclusion Criteria
- Medical conditions that can affect participation in study
- Insufficient command of English language to understand questionnaire
- Using other growth hormone device and not Genotropin pen
Data sourced from ClinicalTrials.gov (NCT00965484). 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.