Ignite Creation Date:
2024-05-05 @ 4:43 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00297375
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2006-02-24
Brief Title:
A Study Comparing the Effectiveness and Safety of ULTRACET Tramadol HClAcetaminophen Versus Placebo for the Treatment of Acute Pain From a Migraine Headache
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Comparison of the Efficacy and Safety of ULTRACET Tramadol HClAcetaminophen Versus Placebo for the Acute Treatment of Migraine Headache Pain
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness and safety of tramadol HClacetaminophen as a pain medication compared with placebo in the treatment of acute pain from a migraine headache Although tramadol HClacetaminophen 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 HClacetaminophen 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 HClacetaminophen 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 HClacetaminophen is safe and effective as a pain medication in the treatment of acute pain associated with a migraine headache
2 tramadol HCl 375 milligramsacetaminophen 325 milligrams combination tablets or 2 matching placebo inactive substance tablets for tramadol HClacetaminophen taken one time orally
2 tramadol HCl 375 milligramsacetaminophen 325 milligrams combination tablets or 2 matching placebo inactive substance tablets for tramadol HClacetaminophen taken one time orally
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None