A Randomized, Double-Blind, Placebo-Controlled Trial Of The Prevention And Treatment Of Chemotherapy-Induced Peripheral Neuropathy Symptoms In Subjects With Advanced Colorectal Cancer
This study was terminated on July 15, 2008. The results of an interim analysis showed that
the conditional power to detect a difference in treatment groups was insufficient to warrant
study continuation and therefore termination of the trial was recommended. The decision to
terminate the trial was not based on safety concerns.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Duration Adjusted Average Change (DAAC) of Paresthesia From the Onset of Chemotherapy Measured by Numeric Rating Scale (NRS)
Period of 10 days from the onset of chemotherapy to the last cycle: Last Observation Carried Forward (LOCF)
No
Pfizer CT.gov Call Center
Study Director
Pfizer
United States: Food and Drug Administration
A0081124
NCT00380874
January 2007
March 2008
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