A Study Comparing the Effectiveness and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Treatment of Acute Pain From a Migraine Headache

A Comparison of the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Acute Treatment of Migraine Headache Pain

The purpose of this study is to evaluate the effectiveness and safety of tramadol HCl/acetaminophen as a pain medication compared with placebo in the treatment of acute pain from a migraine headache. Although tramadol HCl/acetaminophen is approved to treat acute pain, it is not approved for the treatment of acute pain associated with migraine headache. The study hypothesis is that tramadol HCl/acetaminophen is safe and effective as a pain medication in the treatment of acute pain associated with a migraine headache.

Although new drugs and procedures are available to treat acute migraine pain, inadequacies in treatment still exist. The ingredients in tramadol HCl/acetaminophen tablet and the way it works may be effective in the treatment of the pain of acute migraine headache. The combination of tramadol HCl/ acetaminophen works faster than tramadol alone and lasts longer than acetaminophen alone. This is a multicenter, single-dose, outpatient, randomized (study with two groups one in treatment and one control group), double-blind (neither patient nor investigator knows which patient is receiving study drug or control treatment), placebo-controlled, parallel-group (each group receives only one type of treatment) study of adult patients who experience at least moderate pain from migraine headaches. After being randomly assigned to a group patients will leave the study center with one dose (2 tablets) of study medication, either active treatment or placebo. The next time the patient has a migraine headache of at least moderate pain, the patient will take the study medication and start to answer questions about their headache pain and pain relief in a study diary. Patients should return to the study center within 72 hours of taking this dose. The study hypothesis is that tramadol HCl/acetaminophen is safe and effective as a pain medication in the treatment of acute pain associated with a migraine headache.

2 tramadol HCl (37.5 milligrams)/acetaminophen (325 milligrams) combination tablets or 2 matching placebo (inactive substance) tablets for tramadol HCl/acetaminophen taken one time orally

Inclusion Criteria:

• Patient with a history of diagnosis of migraine with or without a warning sign (aura), that meets the criteria for a migraine, for at least 1 year
• History of migraine pain at least moderate in intensity
• Incidence of 1 to 6 headaches per month in the past year
• If female, using acceptable method of birth control

Exclusion Criteria:

• Patients with routine headaches that could be confused with migraines
• No more than 13 headache days per month in the past 6 months
• Onset of migraines after age 50
• Patients with migraines involving the eyes, chronic migraine or cluster headaches
• Patients using one or more of the following medications before study entry: more than 1 type of migraine prevention medicine in the past 6 weeks, tramadol within 30 days, vitamins/herbal remedies or non-drug-related remedies for migraine for < 30 days, St. John's Wort within 30 days, investigational drug in past 30 days or any other disallowed medications