Genotropin Study Assessing Use of Injection Pen

Pfizer

Status and phase: Completed; Phase 3

Conditions: Idiopathic Short Stature; Growth Hormone Deficiency

Treatments: Device: New Genotropin Pen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00965484

A6281291

Details and patient eligibility

About

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.

Enrollment: 136 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 1 patient group

Genotropin pen

Experimental group

Description:

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

Treatment:

Device: New Genotropin Pen