Headache (Migraine) Clinical Trial
Official title:
A Randomized, Double-Blind, Single-Dose Study, Placebo-Controlled Evaluation of the Safety and Efficacy of Intravenous Lornoxicam in the Acute Treatment of the Headache of Migraine.
| Verified date | November 2012 |
| Source | POZEN |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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 patients with a history of migraine. Two-thirds of patients in this study will receive a single dose of intravenous lornoxicam (8mg or 16 mg) and one-third of patients will receive a single dose of an intravenous placebo.
| Status | Completed |
| Enrollment | 150 |
| Est. completion date | April 2006 |
| Est. primary completion date | April 2006 |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | The Innovative Clinical Research Center | Alexandria | Virginia |
| United States | Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan |
| United States | Alabama Clinical Therapeutics | Birmingham | Alabama |
| United States | University Headache Center | Chapel Hill | North Carolina |
| United States | Diamond Headache Clinic | Chicago | Illinois |
| United States | Headache Wellness Center | Greensboro | North Carolina |
| United States | Houston Headache Clinic | Houston | Texas |
| United States | Little Rock Family Practice Clinic | Little Rock | Arkansas |
| United States | University of South Alabama Neurology | Mobile | Alabama |
| United States | Clinical Research Associates, Inc. | Nashville | Tennessee |
| United States | C. Phillip O'Carroll, MD, Inc. | Newport Beach | California |
| United States | NE Medical Research Associates, Inc. | North Dartmouth | Massachusetts |
| United States | Jefferson Headache Center | Philadelphia | Pennsylvania |
| United States | Clinical Research Institute | Plymouth | Minnesota |
| United States | North Carolina Clinical Research | Raleigh | North Carolina |
| United States | Jean Brown Research | Salt Lake City | Utah |
| United States | California Medical Clinic for Headache | Santa Monica | California |
| United States | Swedish Pain Center | Seattle | Washington |
| United States | Headache Care Center | Springfield | Missouri |
| United States | Mercy Health Reserach / Ryan Headache Center | St. Louis | Missouri |
| United States | Meridien Research | St. Petersburg | Florida |
| United States | New England Center for Headache | Stamford | Connecticut |
| United States | Premiere Research Institute | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| POZEN |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of headache pain intensity over 24 hours after treatment, rated on a categorical scale of 0-3 and a visual analog scale (VAS). | |||
| Secondary | Assessments of symptoms of photophobia, phonophobia, nausea and vomiting, rated as present or absent; use of rescue medication in the 24 hours after dosing; response of allodynia symptoms present at time of treatment. |