Genotropin Study Assessing Use of Injection Pen

Condition(s) targeted: Growth Hormone Deficiency; Idiopathic Short Stature

Intervention: New Genotropin Pen (Device)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: Multicenter, Open-Label Study Assessing Dyad (Subject And Caregiver) Perception Of Convenience And Preference Of The Newly Developed Mark VII Injection Pen

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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®

Secondary outcome:

Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®

Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®

Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®

Minimum age: 8 Years. Maximum age: 18 Years. Gender(s): Both.

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

Pfizer Investigational Site, Los Angeles, California 90048, United States

Pfizer Investigational Site, San Diego, California 92123-4282, United States

Pfizer Investigational Site, Greenwood Village, Colorado 80111, United States

Pfizer Investigational Site, Gainesville, Florida 32608, United States

Pfizer Investigational Site, Gainesville, Florida 32610, United States

Pfizer Investigational Site, Tallahassee, Florida 32308, United States

Pfizer Investigational Site, Indianapolis, Indiana 46202, United States

Pfizer Investigational Site, Baltimore, Maryland 21201, United States

Pfizer Investigational Site, Baltimore, Maryland 21229, United States

Pfizer Investigational Site, Southaven, Mississippi 38671, United States

Pfizer Investigational Site, Kansas City, Missouri 64108, United States

Pfizer Investigational Site, Morristown, New Jersey 07962, United States

Pfizer Investigational Site, Akron, Ohio 44308, United States

Pfizer Investigational Site, Columbus, Ohio 43205, United States

Pfizer Investigational Site, Philadelphia, Pennsylvania 19107, United States

Pfizer Investigational Site, Pittsburgh, Pennsylvania 15218, United States

Pfizer Investigational Site, Charleston, South Carolina 29425, United States

Pfizer Investigational Site, Florence, South Carolina 29506, United States

Pfizer Investigational Site, Memphis, Tennessee 38105, United States

Pfizer Investigational Site, Memphis, Tennessee 38119, United States

Pfizer Investigational Site, Dallas, Texas 75230, United States

Pfizer Investigational Site, Dallas, Texas 75235, United States

Pfizer Investigational Site, Fort Worth, Texas 76104, United States

Pfizer Investigational Site, San Antonio, Texas 78229, United States

Pfizer Investigational Site, Seattle, Washington 98105, United States

To obtain contact information for a study center near you, click here.

Starting date: October 2009
Last updated: January 26, 2011