Last updated date
ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
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
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
- Los Angeles, California
- San Diego, California
- Greenwood Village, Colorado
- Gainesville, Florida
- Gainesville, Florida
- Tallahassee, Florida
- Indianapolis, Indiana
- Baltimore, Maryland
- Baltimore, Maryland
- Southaven, Mississippi
- Kansas City, Missouri
- Morristown, New Jersey
- Akron, Ohio
- Columbus, Ohio
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Charleston, South Carolina
- Florence, South Carolina
- Memphis, Tennessee
- Memphis, Tennessee
- Dallas, Texas
- Dallas, Texas
- Fort Worth, Texas
- San Antonio, Texas
- 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 |
| |||
| 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 | 136 | |||
| Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||