Back to resultsStudy of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.
Primary Purpose
Headache (Migraine)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lornoxicam 8 mg
Lornoxicam 16 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Headache (Migraine)
Eligibility Criteria
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.
Sites / Locations
- Alabama Clinical Therapeutics
- University of South Alabama Neurology
- Little Rock Family Practice Clinic
- C. Phillip O'Carroll, MD, Inc.
- California Medical Clinic for Headache
- New England Center for Headache
- Meridien Research
- Premiere Research Institute
- Diamond Headache Clinic
- NE Medical Research Associates, Inc.
- Michigan Head Pain and Neurological Institute
- Clinical Research Institute
- Headache Care Center
- Mercy Health Reserach / Ryan Headache Center
- University Headache Center
- Headache Wellness Center
- North Carolina Clinical Research
- Jefferson Headache Center
- Clinical Research Associates, Inc.
- Houston Headache Clinic
- Jean Brown Research
- The Innovative Clinical Research Center
- Swedish Pain Center
Outcomes
Primary Outcome Measures
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 Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00293657
Brief Title
Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
April 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
POZEN
4. Oversight
5. Study Description
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 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.
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 being females between the ages of 20 and 50 years. Patients with migraine desire rapid and complete relief from headache and decreased frequency of recurrence over the 24 hours after treatment. Current treatments for migraine often provide incomplete pain relief and additional acute treatments are needed. Lornoxicam is a member of the NSAID class of anti-inflammatory drugs and is shown to be effective in the acute management of postoperative pain and arthritis. The current study will evaluate the efficacy of single doses of lornoxicam, administered intravenously, in treatment of the headache of migraine to determine possible future uses of this drug in this condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache (Migraine)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Lornoxicam 8 mg
Intervention Type
Drug
Intervention Name(s)
Lornoxicam 16 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Adelman, MD
Organizational Affiliation
Headache Wellness Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheena Aurora, MD
Organizational Affiliation
Swedish Pain Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gary Berman, MD
Organizational Affiliation
Clinical Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Roger Cady, MD
Organizational Affiliation
Headache Care Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Merle Diamond, MD
Organizational Affiliation
Diamond Headache Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mildred Farmer, MD
Organizational Affiliation
Meridien Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregory Flippo, MD
Organizational Affiliation
Alabama Clinical Therapeutics
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Kahn, MD
Organizational Affiliation
University Headache Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Kudrow, MD
Organizational Affiliation
California Medical Clinic for Headache
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Craig LaForce, MD
Organizational Affiliation
North Carolina Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ninan Mathew, MD
Organizational Affiliation
The Houston Headache Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
S. David Miller, MD
Organizational Affiliation
NE Medical Research Associates, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
C. Phillip O'Carroll, MD
Organizational Affiliation
C. Phillip O'Carroll, MD, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gilbert Podolsky, MD
Organizational Affiliation
Jean Brown Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kevin Roberts, MD
Organizational Affiliation
Little Rock Family Practice Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Rothrock, MD
Organizational Affiliation
University of South Alabama Neurology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Todd Rozen, MD
Organizational Affiliation
Michigan Head Pain and Neurological Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephan Sharp, MD
Organizational Affiliation
Clinical Research Associates, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fred Sheftell, MD
Organizational Affiliation
New England Center for Headache
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Silberstein, MD
Organizational Affiliation
Jefferson Headache Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Timothy Smith, MD
Organizational Affiliation
Mercy Health Research / Ryan Headache Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stuart Stark, MD
Organizational Affiliation
The Innovative Clinical Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Winner, DO
Organizational Affiliation
Premiere Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
University of South Alabama Neurology
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
Country
United States
Facility Name
Little Rock Family Practice Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
C. Phillip O'Carroll, MD, Inc.
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
California Medical Clinic for Headache
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
New England Center for Headache
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Meridien Research
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Premiere Research Institute
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Diamond Headache Clinic
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
NE Medical Research Associates, Inc.
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Michigan Head Pain and Neurological Institute
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Headache Care Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Mercy Health Reserach / Ryan Headache Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
University Headache Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Headache Wellness Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Jefferson Headache Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Clinical Research Associates, Inc.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Houston Headache Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Jean Brown Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
The Innovative Clinical Research Center
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Swedish Pain Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.
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