The primary objective of the study is to determine the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on gastrointestinal (GI)-related events reported in healthy volunteers receiving TECFIDERA™ (dimethyl fumarate \[DMF\]; also known as BG00012) twice daily (BID) The secondary objectives of this study in this study population are: To characterize the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on the frequency, severity, and duration of GI-related events and to evaluate GI-related events that lead to discontinuation of DMF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
175
524 mg bismuth subsalicylate twice a day (BID)
placebo twice a day (BID)
dimethyl fumarate (DMF) twice a day (BID)
Research Site
Daytona Beach, Florida, United States
Research Site
Dallas, Texas, United States
Research Site
Madison, Wisconsin, United States
Time to first gastrointestinal-related event
Time frame: Up to 8 weeks
The number of gastrointestinal-related events.
Time frame: Up to 8 weeks
The duration of gastrointestinal-related events.
Time frame: Up to 8 weeks
The severity of gastrointestinal-related events.
Time frame: Up to 8 weeks
The percentage of subjects who discontinue dimethyl fumarate (DMF) due to gastrointestinal-related events
Time frame: Up to 8 weeks
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