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A Study in Healthy Volunteers to Evaluate Effects of Pre-Medication or Slow Dose Titration on Flushing and Gastrointestinal Events

Healthy Clinical Trial

Official title:
A Randomized, Double-Blind, Phase 3b Study to Evaluate Effects of Aspirin or Slow Dose Titration on Flushing and Gastrointestinal Events Following Oral Administration of BG00012 Dosed at 240 mg BID

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01568112
Study type Interventional
Source Biogen
Contact
Status Completed
Phase Phase 3
Start date April 2012
Completion date October 2012
View Details
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