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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01915901

Enrollment

175

Registered

2013-08-05

Start date

2013-08-31

Completion date

2013-12-31

Last updated

2014-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief 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.

Interventions

DRUGbismuth subsalicylate (Pepto-Bismol®)

524 mg bismuth subsalicylate twice a day (BID)

DRUGmatching placebo (bismuth subsalicylate)

placebo twice a day (BID)

DRUGdimethyl fumarate (DMF)

dimethyl fumarate (DMF) twice a day (BID)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

Key Inclusion Criteria: * Must be in good health as determined by the Principal Investigator (PI) based on medical history and Screening evaluations (clinical laboratory evaluations, 12-lead electrocardiogram (ECG), and vital signs; see below for specific

Exclusion criteria

). * Must have a body mass index (BMI) of 18.0 to 34.0 kg/m2, inclusive. * Subjects of reproductive potential (including males) must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study drug. * Male subjects must agree to not donate sperm for 90 days after their last dose of study drug. * Must be naïve to dimethyl fumarate (DMF) or fumaric acid esters. Key

Design outcomes

Primary

Measure	Time frame
Time to first gastrointestinal-related event	Up to 8 weeks

Secondary

Measure	Time frame
The number of gastrointestinal-related events.	Up to 8 weeks
The duration of gastrointestinal-related events.	Up to 8 weeks
The severity of gastrointestinal-related events.	Up to 8 weeks
The percentage of subjects who discontinue dimethyl fumarate (DMF) due to gastrointestinal-related events	Up to 8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026