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Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier:
NCT00825227
First received: January 15, 2009
Last updated: June 21, 2012
Last verified: June 2012
History of Changes
Results First Received: July 28, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Fatigue
Chemotherapy Side Effects
Interventions: Drug: Armodafinil 150 mg/day
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
No text entered.

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
150 mg/Day Armodafinil
  • 150 mg/day armodafinil
  • taxane chemotherapy treatment alone or in combination with other agents
Matching Placebo
  • placebo
  • taxane chemotherapy treatment alone or in combination with other agents

Participant Flow:   Overall Study
    150 mg/Day Armodafinil     Matching Placebo  
STARTED     6     4  
COMPLETED     6     4  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
150 mg/Day Armodafinil
  • 150 mg/day armodafinil
  • taxane chemotherapy treatment alone or in combination with other agents
Matching Placebo
  • placebo
  • taxane chemotherapy treatment alone or in combination with other agents
Total Total of all reporting groups

Baseline Measures
    150 mg/Day Armodafinil     Matching Placebo     Total  
Number of Participants  
[units: participants]
 		  6     4     10  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     6     4     10  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  59.5  ± 3.73     56.5  ± 5.80     58.3  ± 4.62  
Gender  
[units: participants]
 		     
Female     3     2     5  
Male     3     2     5  
Region of Enrollment  
[units: participants]
 		     
United States     6     4     10  



  Outcome Measures

1.  Primary:   Change Over Time in the Patient's Daily Ratings of Their Worst Fatigue Severity (as Assessed for the Past 24 Hours), Obtained From the Patient's Responses on the Brief Fatigue Inventory (BFI) Questionnaire   [ Time Frame: Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind) ]
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2.  Secondary:   Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire   [ Time Frame: Duration of up to 8 weeks total (Screening and Double-Blind) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Change in the Brief Fatigue Inventory (BFI) Global Score   [ Time Frame: Duration of up to 8 weeks total (Screening and Double-Blind) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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