A Multi-center, Randomized, Double-blind, Parallel-group, Single-dose, Placebo-controlled Study Comparing the Efficacy and Safety of a Combination of Acetaminophen and Aspirin vs Placebo in the Acute Treatment of Migraine

Novartis0 sites900 target enrollmentOctober 2013

ConditionsAcute Migraine

InterventionsPlacebo Acetaminophen 250 mg and Aspirin 250 mg

DrugsAcetaminophen 250 mg and Aspirin 250 mg Placebo

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Acute Migraine
Sponsor: Novartis
Enrollment: 900
Primary Endpoint: Number of Subjects Who Are Pain Free at the 2-hour Assessment
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate the efficacy and safety of acetaminophen and aspirin versus placebo in the acute treatment of migraine

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

July 2014

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

Placebo

2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets

Intervention: Placebo

Acetaminophen 250 mg and aspirin 250 mg

2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg

Intervention: Acetaminophen 250 mg and Aspirin 250 mg

Outcomes

Primary Outcomes

Number of Subjects Who Are Pain Free at the 2-hour Assessment

Time Frame: 2 hours

Number of subjects who are pain free at the 2-hour assessment

Number of Subjects Who Are Nausea Free at the 2-hour Assessment

Time Frame: 2 hours

Number of subjects who are nausea free at the 2-hour assessment

Secondary Outcomes

Number of Subjects Who Are Free of Phonophobia at the 2-hour Assessment.(2 hours)
Number of Subjects Who Are Free of Photophobia at the 2-hour Assessment.(2 hours)