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Genotropin Study Assessing Use of Injection Pen

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00965484
First Posted: August 25, 2009
Last Update Posted: January 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
Results First Submitted: December 2, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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.
No text entered.

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 
Overall Participants Analyzed 
[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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00965484     History of Changes
Other Study ID Numbers: A6281291
First Submitted: August 21, 2009
First Posted: August 25, 2009
Results First Submitted: December 2, 2010
Results First Posted: December 23, 2010
Last Update Posted: January 28, 2011