Official Title: “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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

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

Intervention(s) in this Clinical Trial

• Drug: tramadol HCl/acetaminophen

Primary Measures

• Change in baseline headache pain severity at 2 hours post-dose from severe or moderate to mild or none, without using any nausea medication or other pain medication

Secondary Measures

• Pain free at 2, 6 and 24 hrs post-dose; difference in pain intensity and response to therapy over the first 6 hrs post-dose; reduction in occurrence and severity of symptoms; change in functional disability; subject overall rating of change.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Overall Clinical Trial Officials and Contacts

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial Study Director Johnson & Johnson Pharmaceutical Research & Development, L.L.C.  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00297375

Study ID Number: CR002821

ClinicalTrials.gov Identifier: NCT00297375

Health Authority: United States: Food and Drug Administration

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