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Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00555009
First received: October 24, 2007
Last updated: June 1, 2010
Last verified: March 2009
Results First Received: December 22, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Brain Injuries
Growth Hormone Deficiency
Interventions: Drug: Genotropin
Drug: Placebo

  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
Due to poor recruitment, the study was terminated early; therefore efficacy analyses were not completed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Genotropin Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
Placebo Matching placebo injected SC.

Participant Flow:   Overall Study
    Genotropin     Placebo  
STARTED     4     6  
COMPLETED     2     0  
NOT COMPLETED     2     6  
Withdrawal by Subject                 0                 1  
Terminated by Sponsor                 2                 5  



  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 Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
Placebo Matching placebo injected SC.
Total Total of all reporting groups

Baseline Measures
    Genotropin     Placebo     Total  
Number of Participants  
[units: participants]
  4     6     10  
Age, Customized  
[units: participants]
     
<18 years     0     0     0  
18 - 44 years     4     4     8  
45-64 years     0     2     2  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     4     6     10  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36   [ Time Frame: Baseline, Week 36 ]

2.  Secondary:   Change From Baseline in CogState™ at Week 12 and 24.   [ Time Frame: Baseline, Week 12 and 24 ]

3.  Secondary:   Change From Baseline in Lean Body Mass and Fat Mass at Week 36   [ Time Frame: Baseline, Week 36 ]

4.  Secondary:   Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36   [ Time Frame: Baseline, Week 36 ]

5.  Secondary:   Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36   [ Time Frame: Baseline, Week 36 ]

6.  Secondary:   Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36   [ Time Frame: Baseline, Week 36 ]

7.  Secondary:   Change From Baseline in Cardiovascular Risk   [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ]

8.  Secondary:   Change From Baseline in Weight   [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ]

9.  Secondary:   Change From Baseline in Waist Circumference   [ Time Frame: Baseline, Weeks 2, 4, 12, 24, and 36 ]


  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.govCallCenter@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00555009     History of Changes
Other Study ID Numbers: A6281289
Study First Received: October 24, 2007
Results First Received: December 22, 2009
Last Updated: June 1, 2010
Health Authority: Italy: Agenzia Italiana del Farmaco (AIFA)