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

February 28, 2014 updated by: Biogen

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Research Site
    • Texas
      • Dallas, Texas, United States, 75247
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Exclusion Criteria:

  • History of or positive results at the Screening visit for HIV.
  • History of or positive results at the Screening visit for hepatitis C virus antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
  • History of clinically significant gastrointestinal (GI) disease as determined by the PI (including Crohn's disease, peptic ulcer disease, ulcerative colitis, or confirmed diagnosis of irritable bowel syndrome) or active GI disease with ongoing symptoms.
  • History of severe allergic or anaphylactic reactions, considered clinically relevant by the PI.
  • Known allergy to Pepto-Bismol®, salicylates, or non-steroidal anti-inflammatory drugs, considered clinically relevant by the PI.
  • Female subjects who are pregnant based on results of the serum pregnancy test at Screening or currently breastfeeding.
  • Current enrollment in any other study treatment or disease study.
  • Receipt of any investigational drug within 5 half-lives or 30 days, whichever is longer, prior to study entry.
  • History of alcohol abuse or substance abuse (as determined by the PI) within the previous 5 years, a positive urine drug/alcohol test at Screening, or alcohol use prior to the screening visit.
  • Regular use of any tobacco product, defined as smoke or smokeless product use equivalent to >5 cigarettes/day for any consecutive week, within 3 months prior to Day 1.

Other unspecified reasons that, in the opinion of the PI or Biogen Idec, make the subject unsuitable for enrollment.

Other protocol-defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bismuth subsalicylate (Pepto-Bismol®) + DMF
Subjects will receive dimethyl fumarate (DMF) and bismuth subsalicylate (Pepto-Bismol®).
Drug: bismuth subsalicylate (Pepto-Bismol®)
524 mg bismuth subsalicylate twice a day (BID)
Other Names:
  • Pepto-Bismol®
Drug: dimethyl fumarate (DMF)
dimethyl fumarate (DMF) twice a day (BID)
Other Names:
  • BG00012
  • DMF
  • TECFIDERA™
Experimental: Placebo + DMF
Subjects will receive dimethyl fumarate (DMF) and placebo.
Drug: dimethyl fumarate (DMF)
dimethyl fumarate (DMF) twice a day (BID)
Other Names:
  • BG00012
  • DMF
  • TECFIDERA™
Drug: matching placebo (bismuth subsalicylate)
placebo twice a day (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first gastrointestinal-related event
Time Frame: Up to 8 weeks
Up to 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 1, 2013

First Submitted That Met QC Criteria

August 1, 2013

First Posted (Estimate)

August 5, 2013

Study Record Updates

Last Update Posted (Estimate)

March 3, 2014

Last Update Submitted That Met QC Criteria

February 28, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109HV110

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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