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Type(s) of Cancer
Fatigue
Study Phase
Phase 3
Study Completion Date
2019-05
NCT01781468Uploaded 10-21-2023
Access via NCI by Request
PDS UID: nci-data-527
A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (NuvigilŪ) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma
Provider Information
Provider Data DescriptionDataset NCT01781468-D1-Dataset.csv (final_analysis) is one of 2 datasets associated with PubMed ID 34882169. This dataset contains data presented in the Consort Diagram, Table 1, Table 2, Table 3, eTable 1, eTable 2, eTable 3, eTable 4, and eTable 5.
SponsorAlliance for Clinical Trials in Oncology
Data ProviderNational Cancer Institute
Clinical Trials.gov Information
Brief SummaryThis randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.
ConditionsFatigue
Intervention TypeDrug: armodafinil 150 mg
Other: Placebo
Drug: armodafinil 250 mg
Drug(s)Drug: armodafinil 150 mg
Drug: armodafinil 250 mg
Total Enrolled328
RandomizationRandomized
Blinding MethodDouble
Arms InterventionArm I - Experimental
Arm II - Placebo Comparator
Arm III - Experimental
Secondary IDN10C3
PubMed (PMID)34882169
Collaborator(s)National Cancer Institute (NCI)
Region(s)United States
Age Range18 Years and older (ADULT, OLDER_ADULT)
Files: NCT01781468-D1
Data DictionaryNCT01781468-D1-Data-Dictionary_0.pdf
DATANCT01781468-D1-Dataset_0.csv
OTHERREADME.pdf
Files: NCT01781468-D2
Data DictionaryNCT01781468-D2-Data-Dictionary_0.pdf
DATANCT01781468-D2-Dataset_0.csv
OTHERREADME.pdf
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