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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00467844
First Posted: May 1, 2007
Last Update Posted: July 11, 2014
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 (Responsible Party):
GTx
Results First Submitted: January 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Cachexia
Interventions: Drug: GTx-024
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
GTx -024 1 mg
GTx-024 3 mg
3 mg of Placebo Placebo

Participant Flow:   Overall Study
    GTx -024   GTx-024   3 mg of Placebo
STARTED   53   54   52 
COMPLETED   34   34   38 
NOT COMPLETED   19   20   14 



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

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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  More Information