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NCT01568112 · ClinicalTrials.gov registry record · Phase 3
Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate
A Phase 3 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 3
- Development phase
- 173
- Enrollment target
NCT01568112 is a Phase 3 study that has completed, run by Biogen. The registered enrollment target is 173 participants.
The verdict
NCT01568112, a Phase 3 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 173 participants
- Enrollment target
Study Summary
The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.
Interventions
- DRUG ASA
- DRUG BG00012 (dimethyl fumarate)
- DRUG BG00012 placebo
- DRUG ASA placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2012-04 |
| Est. Completion | 2012-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01568112
The ClinicalTrials.gov registry entry for NCT01568112 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 173 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 4 interventions - of which ASA is the first listed.
NCT01568112 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01568112 about?
NCT01568112 is a clinical study titled "Effect of Aspirin Pretreatment or Slow Dose Titration on Flushing and Gastrointestinal Events in Healthy Volunteers Receiving Delayed-release Dimethyl Fumarate". The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) ...
What is the current status of trial NCT01568112?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2012-04. Estimated completion is 2012-10.
What interventions are being tested in trial NCT01568112?
The interventions under investigation include: ASA (DRUG), BG00012 (dimethyl fumarate) (DRUG), BG00012 placebo (DRUG), ASA placebo (DRUG).
Who is sponsoring clinical trial NCT01568112?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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