Genotropin Study Assessing Use of Injection Pen

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

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.

Study Overview

• Status: Completed
• Conditions: Growth Hormone Deficiency; Idiopathic Short Stature
• Intervention / Treatment: Device: New Genotropin Pen

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Pfizer Investigational Site
    • San Diego, California, United States, 92123-4282
      • Pfizer Investigational Site
  • Colorado
    • Greenwood Village, Colorado, United States, 80111
      • Pfizer Investigational Site
  • Florida
    • Gainesville, Florida, United States, 32608
      • Pfizer Investigational Site
    • Gainesville, Florida, United States, 32610
      • Pfizer Investigational Site
    • Tallahassee, Florida, United States, 32308
      • Pfizer Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pfizer Investigational Site
    • Baltimore, Maryland, United States, 21229
      • Pfizer Investigational Site
  • Mississippi
    • Southaven, Mississippi, United States, 38671
      • Pfizer Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Pfizer Investigational Site
  • New Jersey
    • Morristown, New Jersey, United States, 07962
      • Pfizer Investigational Site
  • Ohio
    • Akron, Ohio, United States, 44308
      • Pfizer Investigational Site
    • Columbus, Ohio, United States, 43205
      • Pfizer Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15218
      • Pfizer Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Pfizer Investigational Site
    • Florence, South Carolina, United States, 29506
      • Pfizer Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Pfizer Investigational Site
    • Memphis, Tennessee, United States, 38105
      • Pfizer Investigational Site
  • Texas
    • Dallas, Texas, United States, 75230
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75235
      • Pfizer Investigational Site
    • Fort Worth, Texas, United States, 76104
      • Pfizer Investigational Site
    • San Antonio, Texas, United States, 78229
      • Pfizer Investigational Site
  • Washington
    • Seattle, Washington, United States, 98105
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genotropin pen; All subjects will receive genotropin pen to use for 2 months.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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®	Ease of use measured using the Injection Pen Assessment Questionnaire (IPAQ) patient-reported outcome (PRO) tool (based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®	Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).	2 months
Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®	Ease of use measured using the IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® Pen (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).	2 months
Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®	Preference for use measured using IPAQ PRO tool (ease of use and preference based on 13 unique characteristics of injection pens). Section I measures ease of use of Genotropin® (very easy, somewhat easy, neither easy nor difficult, somewhat difficult, or very difficult). Section II measures ease of use of new Genotropin Mark VII Pen in comparison to pre-study experience with Genotropin® Pen (Genotropin® Pen easier to use, new injection pen easier to use, or no difference) and preference (prefer Genotropin® Pen, prefer new injection pen, or no preference).	2 months

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

General Publications

• Hey-Hadavi J, Pleil A, Deeb LC, Fuqua JS, Silverman LA, Reiner B, Newfield R, Rajicic N, Wajnrajch MP, Cara JF. Ease of use and preference for a new disposable self-injection pen compared with a reusable pen for administering recombinant human growth hormone: A multicenter, 2-month, single-arm, open-label clinical trial in patient-caregiver dyads. Clin Ther. 2010 Nov;32(12):2036-47. doi: 10.1016/j.clinthera.2010.11.007.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: August 21, 2009
• First Submitted That Met QC Criteria: August 21, 2009
• First Posted (Estimate): August 25, 2009

Study Record Updates

• Last Update Posted (Estimate): January 28, 2011
• Last Update Submitted That Met QC Criteria: January 26, 2011
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: Genotropin Medical device Patient reported outcome
• Additional Relevant MeSH Terms: Endocrine System Diseases; Genetic Diseases, Inborn; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Developmental; Dwarfism
• Other Study ID Numbers: A6281291