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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 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 175 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01915901
The ClinicalTrials.gov registry entry for NCT01915901 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which bismuth subsalicylate (Pepto-Bismol®) is the first listed.
NCT01915901 reports 0 study locations.
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.
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