Clinical trial NCT00965484: Genotropin Study Assessing Use of Injection Pen
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Deficiency
Idiopathic Short Stature
Keywords: Genotropin Medical device Patient reported outcome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-08-25
Enrollment: 136
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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®
timeFrame: 2 months
Secondary outcomes:
measure: Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®
timeFrame: 2 months
measure: Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®
timeFrame: 2 months
measure: Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®
timeFrame: 2 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pfizer Investigational Site
state: California
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Greenwood Village
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: Southaven
country: United States
facility: Pfizer Investigational Site
state: Mississippi
city: Kansas City
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Morristown
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: Akron
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Florence
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Dallas
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Seattle
country: United States
facility: Pfizer Investigational Site
state: Washington
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.