HealthyPhase 1NCT01915901
PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily
A Phase 1 study testing bismuth subsalicylate (Pepto-Bismol®) and dimethyl fumarate (DMF) in people with Healthy, run by Biogen at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- bismuth subsalicylate (Pepto-Bismol®) and dimethyl fumarate (DMF)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 175 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Research Site
Dallas, Texas, 75247
Research Site
Daytona Beach, Florida, 32117
Research Site
Madison, Wisconsin, 53704
About this study
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
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
- Being tested
- bismuth subsalicylate (Pepto-Bismol®), matching placebo (bismuth subsalicylate), dimethyl fumarate (DMF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bismuth subsalicylate (Pepto-Bismol®)Drug
Also called Pepto-Bismol®
524 mg bismuth subsalicylate twice a day (BID)
matching placebo (bismuth subsalicylate)Drug
placebo twice a day (BID)
dimethyl fumarate (DMF)Drug
Also called BG00012, DMF, TECFIDERA™
dimethyl fumarate (DMF) twice a day (BID)
| Study group | Role | What they receive |
|---|---|---|
| bismuth subsalicylate (Pepto-Bismol®) + DMF | Experimental | Subjects will receive dimethyl fumarate (DMF) and bismuth subsalicylate (Pepto-Bismol®). Receives: Drug: bismuth subsalicylate (Pepto-Bismol®); Drug: dimethyl fumarate (DMF) |
| Placebo + DMF | Experimental | Subjects will receive dimethyl fumarate (DMF) and placebo. Receives: Drug: matching placebo (bismuth subsalicylate); Drug: dimethyl fumarate (DMF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first gastrointestinal-related event
Measured: Up to 8 weeks
Secondary outcomes (4)
The number of gastrointestinal-related events.
Measured: Up to 8 weeks
The duration of gastrointestinal-related events.
Measured: Up to 8 weeks
The severity of gastrointestinal-related events.
Measured: Up to 8 weeks
The percentage of subjects who discontinue dimethyl fumarate (DMF) due to gastrointestinal-related events
Measured: Up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01915901
- Sponsor's protocol ID
- 109HV110
- Status last verified
- Feb 2014
- First submitted
- 1 Aug 2013
- Last updated
- 3 Mar 2014
- Results posted
- No
Publications
Koulinska I, Riester K, Chalkias S, Edwards MR. Effect of Bismuth Subsalicylate on Gastrointestinal Tolerability in Healthy Volunteers Receiving Oral Delayed-release Dimethyl Fumarate: PREVENT, a Randomized, Multicenter, Double-blind, Placebo-controlled Study. Clin Ther. 2018 Dec;40(12):2021-2030.e1. doi: 10.1016/j.clinthera.2018.10.013. Epub 2018 Nov 15.
PubMed 30447891
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01915901
- Acronym / sponsor ID
- 109HV110
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bismuth subsalicylate (Pepto-Bismol®) + DMF | Experimental | Drug: bismuth subsalicylate (Pepto-Bismol®), Drug: dimethyl fumarate (DMF)Subjects will receive dimethyl fumarate (DMF) and bismuth subsalicylate (Pepto-Bismol®). |
| Placebo + DMF | Experimental | Drug: matching placebo (bismuth subsalicylate), Drug: dimethyl fumarate (DMF)Subjects will receive dimethyl fumarate (DMF) and placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bismuth subsalicylate (Pepto-Bismol®)Also: Pepto-Bismol®524 mg bismuth subsalicylate twice a day (BID) | Drug | bismuth subsalicylate (Pepto-Bismol®) + DMF |
| matching placebo (bismuth subsalicylate)placebo twice a day (BID) | Drug | Placebo + DMF |
| dimethyl fumarate (DMF)Also: BG00012, DMF, TECFIDERA™dimethyl fumarate (DMF) twice a day (BID) | Drug | Placebo + DMF, bismuth subsalicylate (Pepto-Bismol®) + DMF |
Primary outcome
Time to first gastrointestinal-related event
Time frame: Up to 8 weeks
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
- Derived from this study: PubMed 30447891Koulinska I, Riester K, Chalkias S, Edwards MR. Effect of Bismuth Subsalicylate on Gastrointestinal Tolerability in Healthy Volunteers Receiving Oral Delayed-release Dimethyl Fumarate: PREVENT, a Randomized, Multicenter, Double-blind, Placebo-controlled Study. Clin Ther. 2018 Dec;40(12):2021-2030.e1. doi: 10.1016/j.clinthera.2018.10.013. Epub 2018 Nov 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bismuth subsalicylate (Pepto-Bismol®) and dimethyl fumarate (DMF) in people with Healthy, run by Biogen at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first gastrointestinal-related event (time frame: Up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01915901, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2014.