Status:
COMPLETED
Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.
Lead Sponsor:
POZEN
Conditions:
Headache (Migraine)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for the acute treatment of moderate or severe headache associated with a single migraine attack in patie...
Detailed Description
The headache of migraine is the primary symptom of this disorder that is estimated to affect approximately 10% of the population of developed countries, with the majority of persons with migraine bein...
Eligibility Criteria
Inclusion
- Subjects must have a demonstrated history of migraine headaches according to the International Headache Society (IHS) criteria 1.1 or 1.2 (2004), had their first migraine prior to age 50, and have had an average migraine headache frequency of 2-6 migraines per month, of moderate or severe pain intensity, in each of the last 6 months prior to screening.
- Subjects are willing to come to the study site when he/she has onset of the headache of migraine to receive an intravenous dose of study medication and is willing to remain in the investigator's clinic for at least 2 hours after the intravenous dose for collection of study data (Subject is discharged to home after 2 hour post-dose evaluations are completed).
Exclusion
- Subjects who are pregnant.
- Subjects has known allergic reactions or intolerance to NSAIDs; any subject in whom aspirin or other non-steroidal anti-inflammatory/analgesic drugs induce the symptoms of asthma, rhinitis and nasal polyps.
- Subject is receiving any medications known or suspected to have drug interactions with lornoxicam. These include: warfarin or other anticoagulants, digoxin, probenecid, methotrexate, lithium, aspirin, cimetidine, cyclosporine and/or furosemide.
- Subjects with a non-migraine (i.e., tension-type, sinus, etc.) headache frequency of \>15 days/month in each of the 3 months (90 days) prior to screening.
- Subjects experiencing greater than an average of 6 migraine attacks per month and/or \>15 migraine days per month in the 6 months prior to screening.
- Subjects with a history of documented gastrointestinal ulceration in the past six months or hospitalization for gastrointestinal bleeding in the past year.
- Subjects with history of impaired renal function and/or a history of kidney disease, interstitial nephritis, nephrotic syndrome, and/or peripheral edema.
- Subjects with history of heart disease or certain related conditions.
- Subjects with uncontrolled hypertension or hypertension that is difficult to control with medications.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00293657
Start Date
December 1 2005
End Date
April 1 2006
Last Update
December 3 2012
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
2
University of South Alabama Neurology
Mobile, Alabama, United States, 36693
3
Little Rock Family Practice Clinic
Little Rock, Arkansas, United States, 72205
4
C. Phillip O'Carroll, MD, Inc.
Newport Beach, California, United States, 92660