Migraine Clinical Trial
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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