PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01915901
- Run by
- Biogen
- People needed
- 175
- Starts
- 2013-08-01
- Expected to finish
- 2013-12-01
- Last updated by the study team
- 2014-03-03
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
Where it is running
- Research Site — Daytona Beach, Florida, United States
- Research Site — Dallas, Texas, United States
- Research Site — Madison, Wisconsin, United States
Full record on ClinicalTrials.gov
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