Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GTx
ClinicalTrials.gov Identifier:
NCT00467844
First received: April 30, 2007
Last updated: June 26, 2014
Last verified: June 2014
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Cachexia
Interventions: Drug: GTx-024
Drug: Placebo

  Participant Flow


  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
GTx -024 1 mg
GTx-024 3 mg
3 mg of Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    GTx -024     GTx-024     3 mg of Placebo     Total  
Number of Participants  
[units: participants]
  53     54     52     159  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     25     22     24     71  
>=65 years     28     32     28     88  
Age  
[units: years]
Mean ± Standard Deviation
  65.7  ± 10.03     66.3  ± 10.51     65.6  ± 8.73     65.9  ± 9.74  
Gender  
[units: participants]
       
Female     19     20     17     56  
Male     34     34     35     103  
Region of Enrollment  
[units: participants]
       
United States     39     37     36     112  
Argentina     14     17     16     47  



  Outcome Measures
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1.  Primary:   The Efficacy of GTx-024 on Total Body Lean Mass.   [ Time Frame: Baseline to Four Months ]

2.  Secondary:   To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.   [ Time Frame: Four 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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