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NCT01915901 · ClinicalTrials.gov registry record · Phase 1
PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 175
- Enrollment target
NCT01915901: Completed Phase 1 study, sponsored by Biogen.
NCT01915901 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 175 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (192% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01915901, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 175 participants
- Enrollment target
Study 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
- DRUG bismuth subsalicylate (Pepto-Bismol®)
- DRUG matching placebo (bismuth subsalicylate)
- DRUG dimethyl fumarate (DMF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2013-08 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01915901 record still lists
NCT01915901 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (192% higher).
The record links to 0 conditions, and to 3 interventions - of which bismuth subsalicylate (Pepto-Bismol®) is the first listed.
NCT01915901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01915901 about?
NCT01915901 is a clinical study titled "PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] 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 ...
What is the current status of trial NCT01915901?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 175 participants. The study started on 2013-08. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01915901?
The interventions under investigation include: bismuth subsalicylate (Pepto-Bismol®) (DRUG), matching placebo (bismuth subsalicylate) (DRUG), dimethyl fumarate (DMF) (DRUG).
Who is sponsoring clinical trial NCT01915901?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01915901's enrollment target sits among peer trials
175 319th of 2000 higher than 1,679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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