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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00965484
Other study ID # A6281291
Secondary ID
Status Completed
Phase Phase 3
First received August 21, 2009
Last updated January 26, 2011
Start date October 2009
Est. completion date January 2010

Study information

Verified date April 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 18 Years
Eligibility 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 Design

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


Intervention

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

Locations

Country Name City State
United States Pfizer Investigational Site Akron Ohio
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Baltimore Maryland
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Columbus Ohio
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Florence South Carolina
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Greenwood Village Colorado
United States Pfizer Investigational Site Indianapolis Indiana
United States Pfizer Investigational Site Kansas City Missouri
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Memphis Tennessee
United States Pfizer Investigational Site Morristown New Jersey
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Pittsburgh Pennsylvania
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Seattle Washington
United States Pfizer Investigational Site Southaven Mississippi
United States Pfizer Investigational Site Tallahassee Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
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