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Trial record 38 of 239 for:    (armodafinil)

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

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ClinicalTrials.gov Identifier: NCT00825227
Recruitment Status : Terminated
First Posted : January 19, 2009
Results First Posted : March 13, 2012
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Cephalon )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Fatigue
Chemotherapy Side Effects
Interventions Drug: Armodafinil 150 mg/day
Drug: Placebo,
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description
  • 150 mg/day armodafinil
  • taxane chemotherapy treatment alone or in combination with other agents
  • placebo
  • taxane chemotherapy treatment alone or in combination with other agents
Period Title: Overall Study
Started 6 4
Completed 6 4
Not Completed 0 0
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo Total
Hide Arm/Group Description
  • 150 mg/day armodafinil
  • taxane chemotherapy treatment alone or in combination with other agents
  • placebo
  • taxane chemotherapy treatment alone or in combination with other agents
Total of all reporting groups
Overall Number of Baseline Participants 6 4 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
4
 100.0%
10
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 4 participants 10 participants
59.5  (3.73) 56.5  (5.80) 58.3  (4.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 4 participants 10 participants
Female
3
  50.0%
2
  50.0%
5
  50.0%
Male
3
  50.0%
2
  50.0%
5
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 4 participants 10 participants
6 4 10
1.Primary Outcome
Title 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
Hide Description Brief Fatigue Inventory (BFI) measures fatigue severity and impact on function on 11-point scale (0-10). Primary outcome measure is average daily rating of BFI question 3: worst level of fatigue over past 24-hours. 0 = no fatigue, 10 = worst imaginable. Study was terminated after only a few patients enrolled and therefore efficacy results were not analyzed and are not reported. Maximum response (most fatigue) would score 10 and minimum response (least fatigue) would score 0. Change was measured from Baseline (cycle 1) to cycle 2. Changes based on matching baseline period with cycle 2 period.
Time Frame Recorded once daily by the Patient, for up to 8 weeks total (Screening and Double-Blind)
Hide Outcome Measure Data
Hide Analysis Population Description
Study was discontinued after only 6 subjects were enrolled due to a business decision, so no outcome analysis was done.
Arm/Group Title Placebo Armodafinil 150 mg/Day
Hide Arm/Group Description:
  • Placebo (3 tablets matching armodafinil tablets)
  • taxane chemotherapy treatment alone or in combination with other agents
  • 150 mg/day armodafinil (3 tablets of 50 mg armodafinil)
  • taxane chemotherapy treatment alone or in combination with other agents
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Percentage of Days With Severe Fatigue, From Patient Responses to the Brief Fatigue Inventory (BFI) Assessment Questionnaire
Hide Description The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. 0 represents no fatigue, 10 represents as bad as you can imagine. The percentage of days with severe fatigue as assessed by the BFI was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.
Time Frame Duration of up to 8 weeks total (Screening and Double-Blind)
Hide Outcome Measure Data
Hide Analysis Population Description
This trial was discontinued early after only 10 of 160 planned subjects had been recruited. No efficacy data was analyzed.
Arm/Group Title Patient Responses to 150 mg/Day Armodafinil Patient Responses to Placebo
Hide Arm/Group Description:
  • 150 mg/day armodafinil
  • taxane chemotherapy treatment alone or in combination with other agents

Armodafinil 150 mg/day: - 150 mg/day armodafinil

  • concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
  • patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
  • placebo
  • taxane chemotherapy treatment alone or in combination with other agents

Placebo,: - placebo

  • concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
  • patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in the Brief Fatigue Inventory (BFI) Global Score
Hide Description The Brief Fatigue Inventory (BFI) measures severity of fatigue and impact of fatigue on daily functioning in past 24 hours. It is a 9-item questionnaire that uses an 11-point scale (0-10) to assess severity. Question 3 asks for worst level of fatigue during past 24-hours. 0 represents no fatigue, 10 represents as bad as you can imagine. The global score (0 to 90) determined by adding each item was to be assessed. Study was terminated as a result of a business decision after only a few patients were enrolled and therefore efficacy results were not analyzed and are not reported.
Time Frame Duration of up to 8 weeks total (Screening and Double-Blind)
Hide Outcome Measure Data
Hide Analysis Population Description
This trial was discontinued early after only 10 of 160 planned subjects had been recruited. No efficacy data was analyzed.
Arm/Group Title Patient Responses to 150 mg/Day Armodafinil Patient Responses to Placebo
Hide Arm/Group Description:
  • 150 mg/day armodafinil
  • taxane chemotherapy treatment alone or in combination with other agents

Armodafinil 150 mg/day: - 150 mg/day armodafinil

  • concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
  • patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
  • placebo
  • taxane chemotherapy treatment alone or in combination with other agents

Placebo,: - placebo

  • concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
  • patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Study drug was administered during cycle 2 of taxane therapy which lasted 21 or 28 days. This was followed by a 24-week open-label extension period during which they received armodafinil for a total of 28 weeks during which adverse events were collected.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 150 mg/Day Armodafinil Matching Placebo
Hide Arm/Group Description
  • 150 mg/day armodafinil
  • taxane chemotherapy treatment alone or in combination with other agents
  • placebo
  • taxane chemotherapy treatment alone or in combination with other agents
All-Cause Mortality
150 mg/Day Armodafinil Matching Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
150 mg/Day Armodafinil Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/6 (50.00%)      1/4 (25.00%)    
Gastrointestinal disorders     
Ileus * 1  1/6 (16.67%)  1 0/4 (0.00%)  0
Infections and infestations     
Urinary Tract Infection * 1  1/6 (16.67%)  1 0/4 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Disease Progression (Prostate Cancer) / Prostate Cancer * 1  0/6 (0.00%)  0 1/4 (25.00%)  1
Nervous system disorders     
Syncope * 1  1/6 (16.67%)  1 0/4 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
150 mg/Day Armodafinil Matching Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/6 (83.33%)      3/4 (75.00%)    
Blood and lymphatic system disorders     
Lymphopenia * 1  0/6 (0.00%)  1/4 (25.00%) 
Neutropenia * 1  1/6 (16.67%)  0/4 (0.00%) 
Cardiac disorders     
Tachycardia * 1  1/6 (16.67%)  0/4 (0.00%) 
Gastrointestinal disorders     
Abdominal pain * 1  1/6 (16.67%)  1/4 (25.00%) 
Abdominal pain lower * 1  1/6 (16.67%)  0/4 (0.00%) 
Abdominal pain upper * 1  1/6 (16.67%)  0/4 (0.00%) 
Diarrhoea * 1  1/6 (16.67%)  2/4 (50.00%) 
Dyspepsia * 1  0/6 (0.00%)  1/4 (25.00%) 
Nausea * 1  1/6 (16.67%)  1/4 (25.00%) 
Stomatitis * 1  1/6 (16.67%)  0/4 (0.00%) 
General disorders     
Chest discomfort * 1  1/6 (16.67%)  0/4 (0.00%) 
Chest pain * 1  0/6 (0.00%)  1/4 (25.00%) 
Chills * 1  1/6 (16.67%)  0/4 (0.00%) 
Infections and infestations     
Tooth abscess * 1  1/6 (16.67%)  0/4 (0.00%) 
Injury, poisoning and procedural complications     
Humerus fracture * 1  1/6 (16.67%)  0/4 (0.00%) 
Investigations     
International normalised ratio increased * 1  1/6 (16.67%)  0/4 (0.00%) 
Prothrombin time prolonged * 1  1/6 (16.67%)  0/4 (0.00%) 
Skin turgor decreased * 1  0/6 (0.00%)  1/4 (25.00%) 
Metabolism and nutrition disorders     
Anorexia * 1  1/6 (16.67%)  0/4 (0.00%) 
Hypokalaemia * 1  1/6 (16.67%)  0/4 (0.00%) 
Psychiatric disorders     
Depression * 1  1/6 (16.67%)  0/4 (0.00%) 
Insomnia * 1  1/6 (16.67%)  1/4 (25.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  0/6 (0.00%)  1/4 (25.00%) 
Skin and subcutaneous tissue disorders     
Dry skin * 1  1/6 (16.67%)  0/4 (0.00%) 
Skin lesion * 1  1/6 (16.67%)  0/4 (0.00%) 
Vascular disorders     
Hypertension * 1  0/6 (0.00%)  1/4 (25.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
This trial was discontinued early after only 10 of 160 planned subjects had been recruited. No efficacy data was analyzed.
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.
Results Point of Contact
Name/Title: Vice President, Clinical Research
Organization: Cephalon, Inc.
Phone: 1-800-896-5855
Responsible Party: Teva Pharmaceutical Industries ( Cephalon )
ClinicalTrials.gov Identifier: NCT00825227     History of Changes
Other Study ID Numbers: C10953/2036/ON/US
First Submitted: January 15, 2009
First Posted: January 19, 2009
Results First Submitted: July 28, 2011
Results First Posted: March 13, 2012
Last Update Posted: November 17, 2017