Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-20 @ 6:43 PM
Study NCT ID:
NCT00293657
Status:
COMPLETED
Last Update Posted:
2012-12-03
First Post:
2006-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C059451', 'term': 'lornoxicam'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-29', 'studyFirstSubmitDate': '2006-02-15', 'studyFirstSubmitQcDate': '2006-02-15', 'lastUpdatePostDateStruct': {'date': '2012-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of headache pain intensity over 24 hours after treatment, rated on a categorical scale of 0-3 and a visual analog scale (VAS).'}], 'secondaryOutcomes': [{'measure': '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.'}]}, 'conditionsModule': {'conditions': ['Headache (Migraine)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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.\n* 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).\n\nExclusion Criteria:\n\n* Subjects who are pregnant.\n* 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.\n* 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.\n* 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.\n* 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.\n* Subjects with a history of documented gastrointestinal ulceration in the past six months or hospitalization for gastrointestinal bleeding in the past year.\n* Subjects with history of impaired renal function and/or a history of kidney disease, interstitial nephritis, nephrotic syndrome, and/or peripheral edema.\n* Subjects with history of heart disease or certain related conditions.\n* Subjects with uncontrolled hypertension or hypertension that is difficult to control with medications."}, 'identificationModule': {'nctId': 'NCT00293657', 'briefTitle': 'Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.', 'organization': {'class': 'INDUSTRY', 'fullName': 'POZEN'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'LNP-201'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lornoxicam 8 mg', 'type': 'DRUG'}, {'name': 'Lornoxicam 16 mg', 'type': 'DRUG'}, {'name': 'Placebo', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36693', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama Neurology', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Little Rock Family Practice Clinic', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92660', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': "C. Phillip O'Carroll, MD, Inc.", 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'California Medical Clinic for Headache', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '06902', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'New England Center for Headache', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '33709', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Meridien Research', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33407', 'city': 'West Palm Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Premiere Research Institute', 'geoPoint': {'lat': 26.71534, 'lon': -80.05337}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Diamond Headache Clinic', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02747', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'NE Medical Research Associates, Inc.', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'zip': '48104', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Head Pain and Neurological Institute', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55441', 'city': 'Plymouth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Clinical Research Institute', 'geoPoint': {'lat': 45.01052, 'lon': -93.45551}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Headache Care Center', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Health Reserach / Ryan Headache Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University Headache Center', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Headache Wellness Center', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'North Carolina Clinical Research', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Headache Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Clinical Research Associates, Inc.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77004', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Headache Clinic', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Jean Brown Research', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '22304', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'The Innovative Clinical Research Center', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Pain Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'James Adelman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Headache Wellness Center'}, {'name': 'Sheena Aurora, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Swedish Pain Center'}, {'name': 'Gary Berman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Institute'}, {'name': 'Roger Cady, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Headache Care Center'}, {'name': 'Merle Diamond, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diamond Headache Clinic'}, {'name': 'Mildred Farmer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meridien Research'}, {'name': 'Gregory Flippo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alabama Clinical Therapeutics'}, {'name': 'Kevin Kahn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Headache Center'}, {'name': 'David Kudrow, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'California Medical Clinic for Headache'}, {'name': 'Craig LaForce, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'North Carolina Clinical Research'}, {'name': 'Ninan Mathew, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Houston Headache Clinic'}, {'name': 'S. David Miller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NE Medical Research Associates, Inc.'}, {'name': "C. Phillip O'Carroll, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "C. Phillip O'Carroll, MD, Inc."}, {'name': 'Gilbert Podolsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jean Brown Research'}, {'name': 'Kevin Roberts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Little Rock Family Practice Clinic'}, {'name': 'John Rothrock, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of South Alabama Neurology'}, {'name': 'Todd Rozen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Michigan Head Pain and Neurological Institute'}, {'name': 'Stephan Sharp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Associates, Inc.'}, {'name': 'Fred Sheftell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New England Center for Headache'}, {'name': 'Stephen Silberstein, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jefferson Headache Center'}, {'name': 'Timothy Smith, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mercy Health Research / Ryan Headache Center'}, {'name': 'Stuart Stark, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Innovative Clinical Research Center'}, {'name': 'Paul Winner, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Premiere Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'POZEN', 'class': 'INDUSTRY'}}}}