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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01915901
First Posted: August 5, 2013
Last Update Posted: March 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
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.

Condition Intervention Phase
Healthy Drug: bismuth subsalicylate (Pepto-Bismol®) Drug: matching placebo (bismuth subsalicylate) Drug: dimethyl fumarate (DMF) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • Time to first gastrointestinal-related event [ Time Frame: Up to 8 weeks ]

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

Enrollment: 175
Study Start Date: August 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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: matching placebo (bismuth subsalicylate)
placebo twice a day (BID)
Drug: dimethyl fumarate (DMF)
dimethyl fumarate (DMF) twice a day (BID)
Other Names:
  • BG00012
  • DMF
  • TECFIDERA™

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01915901


Locations
United States, Florida
Research Site
Daytona Beach, Florida, United States, 32117
United States, Texas
Research Site
Dallas, Texas, United States, 75247
United States, Wisconsin
Research Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01915901     History of Changes
Other Study ID Numbers: 109HV110
First Submitted: August 1, 2013
First Posted: August 5, 2013
Last Update Posted: March 3, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Bismuth
Bismuth subsalicylate
Dimethyl Fumarate
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidiarrheals