Efficacy and Safety of Acetaminophen, Aspirin and Caffeine With Sumatriptan in the Acute Treatment of Migraine

Phase 4

Completed

• Conditions: Pain, Migraine
• Interventions: Drug: Placebo; Drug: Aspirin, acetaminophen and caffeine; Drug: Sumatriptan

• Registration Number: NCT01248468
• Lead Sponsor: Novartis

Brief Summary

The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-03-22
• Status Verified: 2012-06
• Results First Submitted QC: 2012-06-22
• Last Update Submitted: 2012-06-22
• Results First Posted: 2012-07-30
• Last Update Posted: 2012-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 752

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
Aspirin, acetaminophen and caffeine	Aspirin, acetaminophen and caffeine	AAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
Sumatriptan (100 mg)	Sumatriptan	1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets

Primary Outcome Measures

Name	Time	Method
Percent of Subjects Who Are Pain Free at 2 Hours.	2 hours	Subjects assessed severity of pain on a 4 point scale (0=none, ..., 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of pain=none at 2 hours were considered pain free at 2 hours

Secondary Outcome Measures

Name	Time	Method
Percent of Subjects Who Are Free of Nausea at 2 Hours.	2 hours	Subjects assessed severity of relevant symptom on a 4 point scale (0=none, ..., 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Percent of Subjects Who Are Free of Phonophobia at 2 Hours.	2 hours	Subjects assessed severity of relevant symptom on a 4 point scale (0=none, ..., 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours
Percent of Subjects Who Are Free of Photophobia at 2 Hours.	2 hours	Subjects assessed severity of relevant symptom on a 4 point scale (0=none, ..., 3=severe) at set time points after dosing through 4 hours. Subjects who indicated severity of relevant symptom=none at 2 hours were considered relevant symptom free at 2 hours