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Genotropin Study Assessing Use of Injection Pen

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Los Angeles, California, 90048 United States
Contact
1-800-718-1021
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

NCT00965484
Pfizer
Completed
Genotropin Study Assessing Use of Injection Pen

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Genotropin Study Assessing Use of Injection Pen
Multicenter, Open-Label Study Assessing Dyad (Subject And Caregiver) Perception Of Convenience And Preference Of The Newly Developed Mark VII Injection Pen
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Growth Hormone Deficiency
  • Idiopathic Short Stature
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
Experimental: Genotropin pen
All subjects will receive genotropin pen to use for 2 months.
Intervention: Device: New Genotropin Pen
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.
 
Completed
136
January 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00965484
A6281291
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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