NCT01915901

PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily

A Multicenter, Double Blind, Placebo-Controlled Study of Pepto-Bismol® (Bismuth Subsalicylate) on Gastrointestinal Tolerability in Healthy Volunteers Receiving Oral TECFIDERA™ (Dimethyl Fumarate) Delayed-Release Capsules Twice Daily

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Biogen · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	bismuth subsalicylate (Pepto-Bismol®)	524 mg bismuth subsalicylate twice a day (BID)
DRUG	matching placebo (bismuth subsalicylate)	placebo twice a day (BID)
DRUG	dimethyl fumarate (DMF)	dimethyl fumarate (DMF) twice a day (BID)

Timeline

• Start date: 2013-08-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-08-05
• Last updated: 2014-03-03

Locations

3 sites across 1 country: United States