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

Information source: Biogen
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: BG00012 (dimethyl fumarate) (Drug); BG00012 placebo (Drug); ASA (Drug); ASA placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Biogen

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Biogen

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 Details

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

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

Primary outcome:

Incidence and severity of flushing based on the Modified Flushing Severity Scale (MFSS)

Incidence and severity of flushing based on the Modified Global Flushing Severity Scale (MGFSS)

The incidence and severity of gastrointestinal events by using modified acute gastrointestinal scale (MAGISS)

The incidence and severity of gastrointestinal events by using modified overall gastrointestinal scale (MOGISS)

Secondary outcome:

Number of Participants with Adverse Events as a measure of safety and tolerability

Duration of Flushing side effects based on modified acute flushing scale and the modified global flushing scale

Duration of GI side effects based on modified acute gastrointestinal scale and modified overall gastrointestinal symptom scale

Eligibility

Minimum age: 25 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Key Inclusion Criteria:

- Must give written informed consent and any authorizations required by local law

- Must have a body mass index (BMI) of between 18. 0 to 34. 0 kg/m2,inclusive.

- Ability to complete the tolerability scales by accurately using the hand-held subject

reporting device

- Subjects of childbearing potential must be willing to practice effective

contraception Key Exclusion Criteria:

- History of clinically significant diseases

- History of severe allergic or anaphylactic reactions

- Intolerance to Aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)

- Diarrhea, constipation, abdominal pain, flushing or nausea within 28 days prior to

Day 1 NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations and Contacts

Research Site, St Paul, Minnesota, United States
Additional Information

Starting date: April 2012
Last updated: November 3, 2014

Page last updated: August 23, 2015

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