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

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.
ClinicalTrials.gov Identifier: NCT00467844
Recruitment Status : Completed
First Posted : May 1, 2007
Results First Posted : February 21, 2013
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):

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

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

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

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