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Phase 3 Completed N=136 Treatment

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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