MigrainePhase 4NCT00297375
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 Phase 4 study testing tramadol HCl/acetaminophen in people with Migraine and Head Pain, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- tramadol HCl/acetaminophen
- How many people
- 375 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Aug 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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 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
- Being tested
- tramadol HCl/acetaminophen
- Keywords
- treatment, Pain, acute, migraine, headache
- Medical subject headings
- Migraine Disorders, Headache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tramadol HCl/acetaminophenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study startApr 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297375
- Sponsor's protocol ID
- CR002821
- Status last verified
- Apr 2010
- First submitted
- 24 Feb 2006
- Last updated
- 10 Jun 2011
- Results posted
- No
Publications
Silberstein SD, Freitag FG, Rozen TD, Kudrow DB, Hewitt DJ, Jordan DM, Fisher AC, Rosenthal NR; CAPSS-223 Investigators. Tramadol/acetaminophen for the treatment of acute migraine pain: findings of a randomized, placebo-controlled trial. Headache. 2005 Nov-Dec;45(10):1317-27. doi: 10.1111/j.1526-4610.2005.00264.x.
PubMed 16324164
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) Versus Placebo for the Acute Treatment of Migraine Headache Pain
- ClinicalTrials.gov ID
- NCT00297375
- Acronym / sponsor ID
- CR002821
- Keywords
- treatment, Pain, acute, migraine, headache
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Study start
- Apr 2003
- Study completion
- Aug 2003 (actual)
- First posted
- 28 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tramadol HCl/acetaminophen | Drug | – |
Primary outcome
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
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2011.
- Results publication: PubMed 16324164Silberstein SD, Freitag FG, Rozen TD, Kudrow DB, Hewitt DJ, Jordan DM, Fisher AC, Rosenthal NR; CAPSS-223 Investigators. Tramadol/acetaminophen for the treatment of acute migraine pain: findings of a randomized, placebo-controlled trial. Headache. 2005 Nov-Dec;45(10):1317-27. doi: 10.1111/j.1526-4610.2005.00264.x.
- A Comparison of the Efficacy and Safety of ULTRACET® (Tramadol HCl/Acetaminophen) versus Placebo for the Acute Treatment of Migraine Headache PainLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tramadol HCl/acetaminophen in people with Migraine and Head Pain, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00297375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2011.