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A Study Comparing the Effectiveness and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Treatment of Acute Pain From a Migraine Headache
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Migraine Head Pain Headache | Drug: tramadol HCl/acetaminophen | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Comparison of the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Acute Treatment of Migraine Headache Pain |
- 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
- 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.
| Enrollment: | 375 |
| Study Start Date: | April 2003 |
| Study Completion Date: | August 2003 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00297375
| Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00297375 History of Changes |
| Other Study ID Numbers: |
CR002821 |
| Study First Received: | February 24, 2006 |
| Last Updated: | June 8, 2011 |
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
|
treatment Pain acute migraine headache |
Additional relevant MeSH terms:
|
Migraine Disorders Headache Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Pain Neurologic Manifestations Signs and Symptoms Acetaminophen |
Tramadol Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics Analgesics, Opioid Narcotics Central Nervous System Depressants |
ClinicalTrials.gov processed this record on July 18, 2017