Genotropin Study Assessing Use of Injection Pen

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Growth Hormone Deficiency Idiopathic Short Stature

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Genotropin pen

All subjects will receive genotropin pen to use for 2 months.

Group Type EXPERIMENTAL

New Genotropin Pen

Intervention Type DEVICE

Subjects will use the genotropin pen for 2 months. After 2 months patients and caregiver will be asked to fill out a questionnaire to assess perception of the genotropin pen

Interventions

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New Genotropin Pen

Subjects will use the genotropin pen for 2 months. After 2 months patients and caregiver will be asked to fill out a questionnaire to assess perception of the genotropin pen

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

8 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No