Genotropin Study Assessing Use of Injection Pen

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00965484
First received: August 21, 2009
Last updated: January 26, 2011
Last verified: April 2010
Results First Received: December 2, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Growth Hormone Deficiency
Idiopathic Short Stature
Intervention: Device: New Genotropin Pen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who used the Genotropin® Pen for at least 3 months prior to enrollment were eligible to participate. Genotropin (somatropin) dose was not adjusted for the purposes of the study, but only based on clinical management requirements as determined by the treating physician.

Reporting Groups
  Description
Genotropin / Genotropin Mark VII Pen Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.

Participant Flow:   Overall Study
    Genotropin / Genotropin Mark VII Pen  
STARTED     136  
COMPLETED     134  
NOT COMPLETED     2  
Protocol Violation                 1  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Genotropin / Genotropin Mark VII Pen Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.

Baseline Measures
    Genotropin / Genotropin Mark VII Pen  
Number of Participants  
[units: participants]
  136  
Age, Customized  
[units: participants]
 
≤10 years of age     37  
Between 11 and 12 years of age     30  
Between 13 and 14 years of age     40  
≥15 years of age     29  
Gender  
[units: participants]
 
Female     45  
Male     91  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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®   [ Time Frame: 2 months ]

2.  Secondary:   Percentage of Dyads Reporting no Preference or Preference for New Genotropin Mark VII Injection Pen Compared to Pre-study Experience With the Genotropin Pen®   [ Time Frame: 2 months ]

3.  Secondary:   Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Easier to Use Compared to Pre-study Experience With the Genotropin Pen®   [ Time Frame: 2 months ]

4.  Secondary:   Percentage of Dyads Reporting New Genotropin Mark VII Injection Pen Preferable Compared to Pre-study Experience With the Genotropin Pen®   [ Time Frame: 2 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00965484     History of Changes
Other Study ID Numbers: A6281291
Study First Received: August 21, 2009
Results First Received: December 2, 2010
Last Updated: January 26, 2011
Health Authority: United States: Food and Drug Administration