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| Sponsor: | Cephalon |
|---|---|
| Information provided by: | Cephalon |
| ClinicalTrials.gov Identifier: | NCT00825227 |
Purpose
Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer-related Fatigue |
Drug: armodafinil and concurrent taxane treatment (alone or in combination with other agents) Drug: placebo, in addition to taxane treatment (alone or in combination with other agents) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Armodafinil Treatment (150 mg/Day) for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents |
| Enrollment: | 10 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | March 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
1: Active Comparator
|
Drug: armodafinil and concurrent taxane treatment (alone or in combination with other agents)
|
2: Placebo Comparator
|
Drug: placebo, in addition to taxane treatment (alone or in combination with other agents)
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Contacts and Locations
Show 29 Study Locations| Study Director: | Sponsor's Medical Expert | Cephalon |
More Information
| Responsible Party: | Cephalon ( Sponsor's Medical Expert ) |
| Study ID Numbers: | C10953/2036/ON/US |
| Study First Received: | January 15, 2009 |
| Last Updated: | January 22, 2010 |
| ClinicalTrials.gov Identifier: | NCT00825227 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Cancer |
|
Signs and Symptoms Fatigue Antineoplastic Agents Therapeutic Uses Physiological Effects of Drugs Central Nervous System Stimulants |
Protective Agents Neuroprotective Agents Central Nervous System Agents Taxane Pharmacologic Actions Modafinil |