Genotropin Study Assessing Use of Injection Pen

NCT00965484

Last updated date
Study Location
Pfizer Investigational Site
Los Angeles, California, 90048, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Growth Hormone Deficiency, Idiopathic Short Stature
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
8-18 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Age 8-18 years

- Using genotropin pen for at least 3 months prior to study enrollment

- Compliance with genotropin treatment

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Growth Hormone Deficiency, Idiopathic Short StatureGenotropin Study Assessing Use of Injection Pen
NCT00965484
  1. Los Angeles, California
  2. San Diego, California
  3. Greenwood Village, Colorado
  4. Gainesville, Florida
  5. Gainesville, Florida
  6. Tallahassee, Florida
  7. Indianapolis, Indiana
  8. Baltimore, Maryland
  9. Baltimore, Maryland
  10. Southaven, Mississippi
  11. Kansas City, Missouri
  12. Morristown, New Jersey
  13. Akron, Ohio
  14. Columbus, Ohio
  15. Philadelphia, Pennsylvania
  16. Pittsburgh, Pennsylvania
  17. Charleston, South Carolina
  18. Florence, South Carolina
  19. Memphis, Tennessee
  20. Memphis, Tennessee
  21. Dallas, Texas
  22. Dallas, Texas
  23. Fort Worth, Texas
  24. San Antonio, Texas
  25. Seattle, Washington
ALL GENDERS
8 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Genotropin Study Assessing Use of Injection Pen
Official Title  ICMJE Multicenter, Open-Label Study Assessing Dyad (Subject And Caregiver) Perception Of Convenience And Preference Of The Newly Developed Mark VII Injection Pen
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Growth Hormone Deficiency
  • Idiopathic Short Stature
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Genotropin pen
All subjects will receive genotropin pen to use for 2 months.
Intervention: Device: New Genotropin Pen
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 8, 2010)
136
Original Estimated Enrollment  ICMJE
 (submitted: August 21, 2009)
130
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 8 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00965484
Other Study ID Numbers  ICMJE A6281291
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP