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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01568112
First received: March 29, 2012
Last updated: April 20, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the effects of aspirin or slow dose titration on flushing and gastrointestinal events following the administration of oral BG00012.


Condition Intervention Phase
Healthy Volunteers
 Drug: Standard dose BG00012
Drug: Aspirin placebo
Drug: Aspirin
Drug: Escalating doses of BG00012
Drug: BG00012 placebo
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • The incidence and severity of flushing events using the modified acute flushing scale and the modified global flushing scale [ Time Frame: An estimated duration of 8 weeks ] [ Designated as safety issue: Yes ]
  • The incidence and severity of gastrointestinal events by using modified acute gastrointestinal scale and modified overall gastrointestinal symptom scale [ Time Frame: An estimated duration of 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a measure of safety and tolerability [ Time Frame: An estimated duration of 9 weeks ] [ Designated as safety issue: Yes ]
  • Duration of Flushing side effects based on modified acute flushing scale and the modified global flushing scale [ Time Frame: An estimated duration of 8 weeks ] [ Designated as safety issue: Yes ]
  • Duration of GI side effects based on modified acute gastrointestinal scale and modified overall gastrointestinal symptom scale [ Time Frame: An estimated duration of 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 172
Study Start Date: April 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard dose of BG00012 and aspirin Drug: Standard dose BG00012 Drug: Aspirin
Pre-medication of 325mg oral tablet
Placebo Comparator: BG00012 placebo and aspirin placebo Drug: Aspirin placebo Drug: BG00012 placebo
Experimental: Escalating doses of BG00012 Drug: Aspirin placebo Drug: Escalating doses of BG00012
Experimental: Standard dose of BG00012 and aspirin placebo Drug: Standard dose BG00012 Drug: Aspirin placebo

Detailed Description:

This is a study in healthy volunteers to evaluate if aspirin taken before BG00012 administration or slowly titrating BG00012 are able to reduce flushing and gastrointestinal events . This will provide information on how to improve BG00012 tolerability .

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568112

Locations
United States, Minnesota
Research Site
St Paul, Minnesota, United States
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Medical Director, Biogen Idec
ClinicalTrials.gov Identifier: NCT01568112     History of Changes
Other Study ID Numbers: 109HV321
Study First Received: March 29, 2012
Last Updated: April 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
BG00012, Aspirin, Pre-medication, dose titration, flushing events, gastrointestinal events

Additional relevant MeSH terms:
Flushing
Signs and Symptoms
Aspirin
Dimethyl fumarate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
 Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 21, 2013