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NCT00965484 · ClinicalTrials.gov registry record · Phase 3
Genotropin Study Assessing Use of Injection Pen
A Phase 3 study of Growth Hormone Deficiency and Idiopathic Short Stature, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
- 20
- Study locations
NCT00965484: Completed Phase 3 study of Growth Hormone Deficiency and Idiopathic Short Stature, sponsored by Pfizer.
NCT00965484 is a Phase 3 study of Growth Hormone Deficiency and Idiopathic Short Stature that has completed, run by Pfizer. The registered enrollment target is 136 participants, below the 379-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00965484, a Phase 3 study of Growth Hormone Deficiency and Idiopathic Short Stature, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE New Genotropin Pen
Study Locations (20)
Florida
- Pfizer Investigational Site - Gainesville
- Pfizer Investigational Site - Gainesville
- Pfizer Investigational Site - Tallahassee
California
- Pfizer Investigational Site - Los Angeles
- Pfizer Investigational Site - San Diego
Maryland
- Pfizer Investigational Site - Baltimore
- Pfizer Investigational Site - Baltimore
Ohio
- Pfizer Investigational Site - Akron
- Pfizer Investigational Site - Columbus
Pennsylvania
- Pfizer Investigational Site - Philadelphia
- Pfizer Investigational Site - Pittsburgh
South Carolina
- Pfizer Investigational Site - Charleston
- Pfizer Investigational Site - Florence
Tennessee
- Pfizer Investigational Site - Memphis
- Pfizer Investigational Site - Memphis
Colorado
- Pfizer Investigational Site - Greenwood Village
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
What the finished NCT00965484 record still lists
NCT00965484 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 379-participant average among 16 other Growth Hormone Deficiency trials with a reported enrollment target (64% lower).
The record links to 2 conditions, with Growth Hormone Deficiency appearing as the primary indexed condition, and to 1 intervention - of which New Genotropin Pen is the first listed.
NCT00965484 names 20 study sites across 12 states, led by Florida, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT00965484 about?
NCT00965484 is a clinical study titled "Genotropin Study Assessing Use of 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.
What is the current status of trial NCT00965484?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2009-10. Estimated completion is 2010-01.
What conditions does trial NCT00965484 study?
This clinical trial studies the following conditions: Growth Hormone Deficiency, Idiopathic Short Stature.
What interventions are being tested in trial NCT00965484?
The interventions under investigation include: New Genotropin Pen (DEVICE).
Who is sponsoring clinical trial NCT00965484?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00965484 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00965484's enrollment target sits among peer trials
136 5th of 16 higher than 12 of 16 other Growth Hormone Deficiency trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Growth Hormone Deficiency trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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