PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
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.