Genotropin Study Assessing Use of Injection Pen

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00965484
First received: August 21, 2009
Last updated: January 26, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Growth Hormone Deficiency
Idiopathic Short Stature
Device: New Genotropin Pen
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Multicenter, Open-Label Study Assessing Dyad (Subject And Caregiver) Perception Of Convenience And Preference Of The Newly Developed Mark VII Injection Pen

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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® [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen® [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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).

  • Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen® [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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).

  • Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen® [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    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).


Enrollment: 136
Study Start Date: October 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965484

  Hide Study Locations
Locations
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90048
Pfizer Investigational Site
San Diego, California, United States, 92123-4282
United States, Colorado
Pfizer Investigational Site
Greenwood Village, Colorado, United States, 80111
United States, Florida
Pfizer Investigational Site
Gainesville, Florida, United States, 32610
Pfizer Investigational Site
Gainesville, Florida, United States, 32608
Pfizer Investigational Site
Tallahassee, Florida, United States, 32308
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21201
Pfizer Investigational Site
Baltimore, Maryland, United States, 21229
United States, Mississippi
Pfizer Investigational Site
Southaven, Mississippi, United States, 38671
United States, Missouri
Pfizer Investigational Site
Kansas City, Missouri, United States, 64108
United States, New Jersey
Pfizer Investigational Site
Morristown, New Jersey, United States, 07962
United States, Ohio
Pfizer Investigational Site
Akron, Ohio, United States, 44308
Pfizer Investigational Site
Columbus, Ohio, United States, 43205
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15218
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
Pfizer Investigational Site
Florence, South Carolina, United States, 29506
United States, Tennessee
Pfizer Investigational Site
Memphis, Tennessee, United States, 38119
Pfizer Investigational Site
Memphis, Tennessee, United States, 38105
United States, Texas
Pfizer Investigational Site
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
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00965484     History of Changes
Other Study ID Numbers: A6281291
Study First Received: August 21, 2009
Results First Received: December 2, 2010
Last Updated: January 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Genotropin Medical device Patient reported outcome

Additional relevant MeSH terms:
Dwarfism
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Bone Diseases, Endocrine
Hypopituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 29, 2014