Status:
COMPLETED
A Study Comparing the Effectiveness and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Treatment of Acute Pain From a Migraine Headache
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PriCara, Unit of Ortho-McNeil, Inc.
Conditions:
Migraine
Head Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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. ...
Detailed Description
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 ef...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2003
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00297375
Start Date
April 1 2003
End Date
August 1 2003
Last Update
June 10 2011
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