Genotropin Study Assessing Use of Injection Pen

• ClinicalTrials.gov Identifier: NCT00965484
• Recruitment Status: Completed
• First Posted: August 25, 2009
• Results First Posted: December 23, 2010
• Last Update Posted: January 28, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Growth Hormone Deficiency; Idiopathic Short Stature	Device: New Genotropin Pen	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 136 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: October 2009
• Actual Primary Completion Date: January 2010
• Actual Study Completion Date: January 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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 :

1. 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 ]
   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. 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 ]
   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).
3. Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen® [ Time Frame: 2 months ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 8 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• 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

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, 32608

Pfizer Investigational Site

Gainesville, Florida, United States, 32610

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, 38105

Pfizer Investigational Site

Memphis, Tennessee, United States, 38119

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:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• ClinicalTrials.gov Identifier: NCT00965484
• Other Study ID Numbers: A6281291
• First Posted: August 25, 2009
• Results First Posted: December 23, 2010
• Last Update Posted: January 28, 2011
• Last Verified: April 2010

Keywords provided by Pfizer:

Genotropin Medical device Patient reported outcome

Additional relevant MeSH terms:

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Endocrine System Diseases